Great. good morning, everyone. my name is Jessica. I'm a large cap biotech analyst at J.P. Morgan. Delighted to be continuing the conference this morning with Alnylam. Joined by a number of members of the company's management team up on stage. Just as a housekeeping note, we don't have to switch rooms for Q&A this year.
Whoo.
We're gonna stay in this room. There's gonna be mic runners if you wanna raise your hand and ask a question. If you don't wanna do it the old-fashioned way, you can also enter a question electronically on the portal and I can read it off the iPad up here. You can listen to my questions if you don't wanna ask your own. With that, I will pass it over to the company CEO, Yvonne Greenstreet for the presentation.
Thanks, Jessica. I have to say it's wonderful to be here in person to give us an opportunity to share an update on our progress at Alnylam. I'm delighted to be joined on stage with my colleagues, Akshay Vaishnaw, our President, Jeff Poulton, our Chief Financial Officer, Pushkar Garg, our Chief Medical Officer, and Tolga Tanguler, our Chief Commercial Officer. Just a heads up, as you know, during my remarks this morning, I'll be making some forward-looking statements.
Now, as many of you know, Alnylam has been the leader in advancing RNAi therapeutics as a whole new class of innovative medicines. RNAi therapeutics selectively target messenger RNA that encodes disease-causing proteins. By doing so, is able to act upstream of established classes like small molecules and monoclonal antibodies. We've established over the last 20 years or so a modular and reproducible approach to designing new medicines.
With a 100% of the human genome, in theory available for targeting via RNAi, this technology represents a substantial opportunity to significantly expand our ability to fight human disease. Leveraging this, we truly believe that Alnylam is poised to become a top-tier biotech in the years to come. You can see here, 2022 was a banner year for Alnylam. We had many important achievements. Particularly proud of all these achievements in my first year as CEO. I'd like to highlight thre on this slide.
Firstly, the excellent progress with our commercial performance, with strong growth in all of our wholly owned brands. We got landmark results from the eagerly anticipated APOLLO-B Phase III study. In the summer, the regulatory approval and launch of AMVUTTRA, our fifth RNAi therapeutic.
2023 promises to continue this momentum with the first ever clinical data from an RNAi therapeutic in the CNS and pending regulatory review, expansion of ONPATTRO into ATTR amyloidosis with cardiomyopathy. This will mark an important inflection point in the build-out of our TTR franchise. We're now an established commercial organization. As I said, 5 RNAi therapeutics approved, notably in under four years, a remarkable achievement. Here you see results from the four products that we commercialize, ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO.
We're really pleased with the continued steady growth we've delivered across this portfolio. We pre-announced strong preliminary fourth quarter and full year 2022 global net product revenues. In total, we achieved $894 million. This represents a year-over-year growth of 35%, with Q4 quarter-over-quarter growth of 13%, a particularly impressive result.
These results reflect a couple of things. They reflect robust patient demand for our innovative and transformative products, as well as excellent commercial execution. We're absolutely thrilled by our launch progress with AMVUTTRA, approved this past June in the U.S. for hereditary ATTR amyloidosis patients with polyneuropathy. In fact, we've added 400 patients on AMVUTTRA in just the fourth quarter last year, this is double the patient adds in prior quarters achieved by ONPATTRO. You know, this reflects the attractiveness of the product profile to physicians and patients. We'll provide 2023 product revenue guidance and much more color on our commercial performance in our earnings call in February. Of course, we look forward to continuing this trend of commercial excellence across our market set portfolio.
In addition to our commercial assets, Alnylam has a robust, high-yielding clinical pipeline with a diversity of opportunity that you can see here across more than a dozen programs at all stages of development, seeking to address unmet medical needs in rare but also in prevalent diseases, silencing gene targets, not just in the liver, but also in the central nervous system. You know, this is an industry-leading platform and arguably one of the most fulsome clinical pipelines in the biotech industry today. You can also appreciate on this slide the substantial product ownership that we've retained for our pipeline, where we have global or 50-50 rights for the vast majority of our programs. Our focus R&D strategy, driven by the selection of genetically validated targets, has led to an impressive probability of success rate.
As you can see on the right of the slide, currently, our cumulative POS from phase I-III over the last decade is a remarkable 62%, this is far greater than industry averages of around 5%-10%. This is a real testament to the power of our platform, combined with our focus on genetics. We've talked about our Alnylam P5x25 vision, this is really aimed at establishing Alnylam as a top-tier biotech company with transformative medicines in rare and common diseases for patients around the world. With a robust and high-yielding pipeline of first and or best-in-class product candidates from our organic product engine, while at the same time delivering exceptional financial performance.
We believe that 2023 is gonna have many milestones that's going to move us even further along in our quest to realizing this exciting vision. How do we get to P5x25 by 2025? I'd like to share with you a few key potential growth drivers that we believe can propel us on our journey to P5x25 by 2025 and beyond. I'm gonna spend a few minutes just touching on each of these. Starting with the potential near-term expansion of our ATTR amyloidosis franchise, where we aim to become the global leader in delivering impactful and highly differentiated medicines to patients with all forms of ATTR amyloidosis.
Most of you know, ATTR amyloidosis is a debilitating, progressive, and oftentimes fatal disease caused by misfolding of the TTR protein, which accumulates in and damages a wide range of tissues, including the heart, the nerves, and the gut. We're just at the beginning of this exciting growth opportunity for our TTR franchise. We're building off a foundation with ONPATTRO, where ONPATTRO is off to a strong initial launch following, as I said, approval this past June. With positive APOLLO-B results in hand, we submitted the sNDA for ONPATTRO to potentially expand the label to include the many patients with ATTR cardiomyopathy. We expect a decision from the FDA by the end of 2023. Thereafter, we see yet further expansion of the TTR franchise as we look forward to outcomes data from our HELIOS-B study and the potential approval of patisiran for ATTR with cardiomyopathy.
Ultimately, ALN-TTRsc04 from our IKARIA platform, which provides the potential for a once annual dosing regimen with a greater than 90% knockdown of TTR. We were thrilled, last year, truly thrilled to deliver positive results from the APOLLO-B Phase III study, where patisiran demonstrated important benefits in patients with TTR cardiomyopathy. Hit on the primary endpoint with a statistically significant and clinically meaningful improvement relative to placebo in the six-minute walk test at 12 months. Also achieved a statistically significant and clinically meaningful improvement relative to placebo at 12 months on the Kansas City Cardiomyopathy Questionnaire, the study's first secondary endpoint, and a key measure of patient's self-reported health status and quality of life.
These are important measures, validated regulatory endpoints of how patients function and feel, remarkable results when you consider this is just a 12-month study in 360 patients with cardiomyopathy. Importantly, in the study, patisiran demonstrated an acceptable tolerability profile. We're very encouraged by the overall safety of patisiran, including cardiac safety.
Also shown on this slide are some exploratory results that highlight the clinical importance of the primary study results. In the 12 months of the APOLLO-B study, patisiran treated patients were less likely to experience disease progression than those given placebo, according to biomarker-based expert consensus criteria. The planned cohort of patients the same timeframe, approximately a third of patisiran-treated patients experienced a reduction in cardiac uptake of technetium, an indicator of amyloid in the heart.
Collectively, we believe that these results validate the therapeutic hypothesis that RNAi-mediated silencing of TTR has the potential to result in a disease-modifying impact on the cardiac manifestations of ATTR amyloidosis and further enhance our confidence as we look ahead to HELIOS-B. To that end, we also intend to expand the ONPATTRO label to include the treatment of cardiomyopathy and hereditary wild-type ATTR amyloidosis patients. We're doing this through the HELIOS-B phase III study with patisiran. HELIOS-B is fully enrolled, has an endpoint of all-cause mortality and CV events assessed after at least 30 and up to 36 months. Pleased to say we're on track to share top-line results in early 2024. If this study is successful and pending regulatory review, we believe that patisiran as a quarterly subcutaneously injected therapeutic could potentially become a best-in-class product for the treatment of all forms of ATTR amyloidosis.
Like the rest of you, we're eagerly awaiting the conclusion of this study. Now, taking a step back and reflecting on the TTR franchise overall, we believe that we've successfully established a strong foundation in this space over the last 4+ years. Given this foundation, we're now well-positioned to potentially serve the needs of a much larger ATTR amyloidosis patient population with an established suite of commercial, clinical, and manufacturing capabilities. Which could also be efficiently scaled to support our other programs addressing prevalent diseases in our pipeline. Now this is the key second growth driver for the company, our expansion beyond rare diseases to also address some more common disease areas.
Encouraged by the efficacy and safety results from the many studies we've delivered with RNAi programs, we plan to leverage our platform to also address the many unmet needs in more common disease settings like hypertension, NASH, and diabetes. Importantly, the pharmacological features of RNAi therapeutics are uniquely suited for the treatment of chronic prevalent diseases, where durable effects enable infrequent dosing to maximize adherence, and where clamped pharmacology creates the potential for improved efficacy and outcomes. First out of the gate in this regard is what we believe is a very compelling opportunity to address unmet needs in hypertension. Hypertension, as you all know, is a highly prevalent disease with over 200 million people with primary hypertension in just the seven major markets.
Despite the widespread availability of treatments to manage the disease, more than 70% of hypertensive patients are not at their target BP goal. An increased cardiovascular risk is further exacerbated by variability in blood pressure control, inadequate nighttime control, and poor adherence to therapy. All of these factors together contribute to a substantial risk of CV morbidity and mortality. In fact, hypertension is the number one preventable cause of cardiovascular morbidity and mortality. This highlights the critical need for new differentiator therapies that can provide tonic control of blood pressure and improve adherence. Zilebesiran is our investigational RNAi therapeutic for hypertension, and we believe could transform the treatment of this disease. Our phase I data highlight this potential. Outstanding results where we've demonstrated clear preliminary evidence for greater than 90% dose-dependent knockdown of angiotensinogen.
A greater than 20 mm of mercury reduction in systolic blood pressure at six months following a single injection. Tonic blood pressure control over 24 hours. Durable reductions in the mediators of hypertension, namely Ang II and aldosterone. These attributes offer a highly differentiated profile from all existing antihypertensives, including RAS inhibitors. We're announcing today that our KARDIA-1 Phase II study is fully enrolled, thanks to our clinical colleagues as of December, and we're excited to deliver top-line results in mid-2023. We also look forward to KARDIA-2 results at or around year-end 2023. Great progress with zilebesiran. We also look forward to growth opportunities and value creations, not just from programs that we are driving, but from programs that were discovered by Alnylam but driven by partners. You can see a few of these here.
One is ALN-HBV02, or VIR-2218, led by Vir Biotechnology. They're evaluating combination regimens as a potential functional cure for chronic HBV infection. We're looking forward to additional phase II readouts this year, and we'll be making an opt-in decision ahead of phase III. Another program, partnered with Sanofi, is fitusiran. This is a first-in-class RNAi therapeutic targeting antithrombin. Sanofi is conducting multiple phase III studies designed for patients with hemophilia A or B, and with or without inhibitors. Additional phase III data are expected later this year with an NDA submission potentially on track for 2024. The last program I want to highlight is cemdisiran, an RNAi therapeutic targeting complement C5, combined with pozelimab, an antibody against C5 discovered by our partners, Regeneron.
Regeneron are evaluating the role for combination therapy with potent inhibition of C5 in ongoing studies in two complement-mediated diseases, myasthenia gravis and PNH. The third growth driver for the company comes from our sustainable innovation engine. Here, we'll continue to deliver future growth by finding novel targets, driving pipeline expansion to 2025 and beyond. We've continued to invest in major databases associated with rich genomic and phenotypic data like the U.K. Biobank and Our Future Health. We'll also continue to maintain our leadership in RNAi chemistry. We are a platform-based company, and push the boundaries of this technology, bringing forward new program enhancements like IKARIA platform, the Reversir antidote to RNAi knockdown, and the GEMINI bis-RNAi targeting two genes with one formulation.
Extrahepatic delivery provides further opportunities for growth. Had great success targeting genes in the liver, but it's just one organ system, and there are a myriad of opportunities to target genes outside the liver, CNS, eye, muscle, adipose tissue, even tumors. We continue to make good progress in this regard. Indeed, we're on the cusp of seeing important data from ALN-APP, which is our first investigational conjugate RNA therapeutic targeting a gene expressed in the CNS, and in development for the treatment of Alzheimer's disease and cerebral amyloid angiopathy. ALN-APP has the potential to offer a highly differentiated approach in Alzheimer's disease by targeting APP upstream of where antibodies currently target. APP also has the potential to act both intracellularly and extracellularly to reduce disease-causing peptides.
We believe these initial clinical data with ALN-APP, if positive, will be an important milestone, not just for this particular program, but for our overall CNS platform, where we hope to show that RNAi can achieve clinically relevant degrees of target knockdown in the CNS with a safety and dosing profile to support further development. We look forward to sharing top-line results from this study in early 2023. I'd like to wrap up now with a full list of our company goals for 2023. These show that we have a very exciting year ahead. In the interest of time, I won't walk through all of these, but at a high level, we look forward to ongoing commercial execution from the four Alnylam owned products. 10 clinical readouts from proprietary and partner-led programs.
The potential label expansion from Patro and ATTR amyloidosis with cardiomyopathy, assuming successful regulatory review. Filing 2-4 new INDs from our organic R&D engine to bring new programs into the clinic and position Alnylam for sustainable future growth. Ultimately, we have an amazing platform, but our secret source at Alnylam is our people. We're so proud of everything that we've been able to achieve in this remarkable company, thanks to the employees who are fully committed to our mission. You know, we continue to be recognized across biotech and other industries, but for multiple elements of our culture. Our leadership and scientific innovation, diversity, equity, and inclusion, so important to our social responsibility. First and foremost, a steadfast commitment to the patients that we serve.
In closing, I hope I've conveyed to you the excitement that I and my colleagues share about building Alnylam into a top-tier biopharmaceutical company. We've got a bold vision, but the roadmap to get there is clear and actionable. I hope that all of you share the same enthusiasm. I'd like to thank you for your support and your attention, and now transition to Q&A, which is in Jessica's capable hands.
Great. As a reminder, if you wanna ask a question, raise your hand. We'd love to have it be interactive, but I'll start. You pre-announced some numbers, can't even remember if it was yesterday or this morning at this point. It looks like you're seeing really strong conversion over to AMVUTTRA, to some extent from ONPATTRO. Can you talk a little bit about the dynamics you're seeing between the two products in polyneuropathy?
Yeah, happy to do that, and I'll turn it to Tolga in a moment. I just really want to underscore how incredibly well-received AMVUTTRA has been by patients and physicians. I think it really comes down to the, you know, efficacy and safety, but also the quarterly subcutaneous regimen, which essentially helps liberate patients from their disease. We're seeing patients being treated earlier in the course of the disease. We're also seeing switchers, that's an area that I think we'd like to elaborate on a bit. Maybe, Tolga, you can kinda talk about some of the dynamics that we're seeing.
Great to be here. It really is exciting to see the progress that we made with AMVUTTRA since the launch, first in the U.S. six months and last November, December period in Japan and Germany. When you look at the progress we made, I think it validates couple things. One is, first and foremost, there are a lot of patients still in need. This is a rare disease, and there are thousands of undiagnosed and untreated patients that AMVUTTRA's profile is really providing support.
Second is what Yvonne indicated. It validates the fact that AMVUTTRA's safety, efficacy, and subcutaneous quarterly profile really sets it apart as the potentially to be the standard of care. Last but not least is our commercial capabilities.
We built a foundation over five years about the commercial capabilities, and we've been able to from supporting patient diagnosis, securing formulary inclusions, all the way to making sure that the patients get access to this without any headwinds. Those are the dynamics. Now, when you look at all these points, you essentially see that we've now added nearly double the number of patients within the last quarter that we've done historically with ONPATTRO in every quarter, so we're growing the pie. Last but not least, because the profile is so attractive, both patients and physicians are switching over to ONPATTRO, that only represents 50% of our current total patient basis. Essentially this is really growing the pie, and that's what we're really excited about.
We're really pleased with the dynamic. I think it demonstrates just how well AMVUTTRA is being received and the difference that we're able to make to patients. I think the really important point that Tolga made is that we see this as an opportunity to grow the overall franchise.
How important is the every six month data, and how much of a tailwind could that create on sort of on top of what you're already seeing?
That's a great question. You know, maybe just to kind of reiterate some of the points we've already made around AMVUTTRA, the quarterly subcutaneous regimen, which has been so incredibly well received. Actually, I think beyond our initial expectations. I think, you know, six monthly would be a nice-to-have, but it's absolutely not a must-have. I think what we really have in our hands right now is a winning profile for the current formulation of AMVUTTRA. Anything else, Tolga?
Well, I mean, it also, if you think of the competitive landscape. The subcutaneous quarterly administration really sets us apart regardless of the six-month data. Obviously with the six-month data, it could certainly help us. As Yvonne put it's a nice to have.
Yeah.
Question in the audience. Can we have a mic up front?
Anybody want to ask questions, particularly about maybe our TTR franchise while we're on the topic? We're very excited about it. Somebody?
Can you just speak up and we can repeat it?
Come use the mic.
First row here.
Would it benefit you if you had 100,000 family whole genomes, and within each family there's amyloidosis? Would it help you to have that data set?
Well, I mean, look, We believe in the power of genetics. We already invest in, you know, a broad range of, as I said, genomic and phenotypic data sets. I don't know if you've got anything specific to your mind as you make that, comment, but happy to follow up with you afterwards if there's something specific.
Well, I was told to ask the question by our chief medical officer. He's not here, but it's Dr. Reynolds Delgado.
Right
...who's in the Texas Heart Institute in the Texas Medical Center, and with six of the leading cardiologists, primarily transplant people, primarily with amyloidosis. We've developed a whole genome screenings of entire families with the amyloidosis.
Yeah. Well, we'd love to hear more about it. Maybe, you know, Pushkal Garg, our Chief Medical Officer-
I just happen to have our book.
Okay. Awesome.
Maybe sticking with, TTR, but switching to the patisiran submission for cardiomyopathy. Have you gotten any initial feedback from the FDA on that sNDA, and do you expect a priority review or a standard review timeline?
Yeah, look, I'd just like to start off by saying that, you know, as many of you know, we aligned with the FDA on the design and the conduct of the APOLLO-B study, and we're absolutely delighted by the results. I mean, flawlessly executed the study. I shared with you some of the highlights of the data that we were able to generate for patisiran, you know, across multiple endpoints, not just the, you know, primary endpoint that I described, the six minute walk test or the KCCQ.
Also, you know, improvements in cardiac safety, patients receiving placebo compared to patisiran compared to placebo. Numerical benefits and mortality and a number of exploratory endpoints. We feel that what we've been able to submit to the FDA is actually a very compelling data package.
Of course, it's against the backdrop of significant unmet medical need in this area, where patients continue to progress, despite currently available treatments. We think there's a real need to bring forward an innovation like ONPATTRO for patients with ATTR amyloidosis. That being said, you know, we expect a standard review and the details of the review by the FDA as they consider the risk-benefit will be something that I'm sure they will declare on in due course. As I said, with the submission of the sNDA in December of last year, we expect a PDUFA date in quarter four 2023.
We have 1 question on the portal here. Do you expect a advisory committee for that filing?
Yeah, you know, I'll take that. It really is very difficult to make specific comments about, you know, the regulatory process. I mean, just to reiterate the fact that we believe that we've submitted a really compelling package. We believe there's significant unmet medical need in this area. We will await the review by the agency.
Is there any possibility that given how soon after your PDUFA the HELIOS-B results will become available that the FDA could want to see those data before acting on the patisiran filing?
I think it's important to note that, I mean, you know, AMVUTTRA is a completely different molecule, from ONPATTRO. The HELIOS-B study is a completely different study, you know, measuring outcomes and it's done over a very different, you know, timeframe. I think the other point to make is actually, you know, as I said in my remarks, we will, you know, get the HELIOS-B readout at in early 2024. I think it's highly unlikely, but Pushkal maybe you want to add an additional perspective.
Yeah. It's an interesting question. We've aligned with the FDA on the design of the study. As Yvonne presented, the results are extraordinarily internally consistent, both from the efficacy side, the safety side, and the exploratory data. I'll also remind, this is an sNDA for a product that's been on the market and now has been treated in over 3,000 patients for the last four years. I think we feel really good about the dataset that we have, and I think that, you know, the FDA will be able to evaluate that dataset fully.
understand the implications and hopefully reach a successful conclusion in terms of approving it for these patients who have a dramatic need for new therapies.
We had another question from the audience.
I was just hoping you could tell us a little bit more about the ALN-APP program. I think you mentioned that you're gonna be seeing data from the phase one trial. Specifically some of the Alzheimer's companies have been pretty aggressive in terms of accelerating the process of getting through clinical trials. We now have anti-amyloid drug approved.
Yeah.
Help us understand what we're going to be looking for in terms of efficacy in this phase I, and then what that means for your development timeline.
I'll make a couple of points, then invite, Pushkar.
Can you repeat the beginning of the question?
Sorry. I'll make a couple of points and invite Pushkar also to add some color. We've got a phase I study ongoing, as I said, in patients with early onset Alzheimer's disease. We expect to see those data in early 2023. The study is designed to assess safety. It's really important in an early study, but also to look at target engagement, and we'll be measuring biomarkers, sAPPα and sAPPβ. We're actually very encouraged by, you know, the progress that's been made around the amyloid hypothesis, because we actually think this is an important contributor to how to think about the amyloid hypothesis.
We believe that the mechanisms of action that we have with our RNAi program, ALN-APP, has some real advantages in terms of switching APP off at its source, but also acting intracellularly and extracellularly. We're really excited about seeing those data and hope to be able to share those with you in the near term. I don't know, Pushkar, if you wanna make any additional comments.
Not much. Maybe just I'll say again, I think, you know, as Yvonne said, I think it's great to see the progress that's happened in the field. I think these patients, obviously, we all agree, really need new therapies first and foremost. I think it suggests that the hypothesis around addressing amyloid is fundamentally important, and I think we have a very differentiated approach to do that by both addressing intracellular and extracellular amyloid, sorry, as well as, you know, various fragment lengths of amyloid by turning off upstream. We are doing this phase I study. I think it's very important in the sense that we will, A, look at safety and tolerability of administering an RNAi therapeutic for the first time intrathecally.
We'll also be able to get a sense of knockdown, looking at soluble APPα and sAPPβ, as well as the durability. I'll remind you that our non-human primate studies, we're able to use a single injection intrathecally and see knockdown for up to six months or more. That provides the opportunity for a very interesting profile. You asked about after that. You know, we'll continue to accelerate and move forward in a single ascending dose and a multiple ascending dose study. There's a couple of avenues in terms of opportunities to help patients with this disease, both Alzheimer's disease as well as cerebral amyloid angiopathy. We'll determine the development path. Of course, this will also hopefully open up opportunities to address other CNS diseases with RNAi therapeutics as well.
A lot of exciting progress hopefully on the horizon.
It's a really important point, Pushkar, that we see this program as actually as de-risking for our ambitions in the CNS. There's so many diseases that we'd like to be able to tackle that we're looking forward eagerly to seeing the phase I data from ALN-APP early this year. Jessica, any other questions? Anything?
Maybe back to TTR, another one that came in on the portal. How do you think about pricing for vutrisiran in the context of tafamidis generics, especially in Europe?
Yeah, it's a great question. Pricing, obviously an important topic. It's clearly a little early to be discussing pricing, but Tolga, you may have a couple of comments that would be helpful here.
Yeah. I mean, obviously, we're going to do our best to maximize the asset's value. When it comes to thinking about different relevant, prevalence, vutrisiran, isoxsuprine and CM, I think that's the question...
Yeah.
about cardiomyopathy, we would be addressing tenfold of the number of patients. Having said that, as Yvonne indicated, it's a highly competitive marketplace. I think it's too soon for us to make any, you know, statements around how we would actually price this.
I think it was about a month ago at your R&D day, you showed some data on zilebesiran that showed a salt effect, and I was curious if you could just elaborate a little bit on what you think that means for the product or any implications for how you would develop it or how it would be used?
Yeah, no. You know, again, just to reiterate that, look, you know, we're very pleased with the progress of zilebesiran. We really see zilebesiran having the potential for major impact on hypertension. Remember, this is an area that hasn't had any innovation, really, for years and years. This is a, this is a potential kind of breakthrough in the space. Actually, you might want to comment specifically on the details of the phase I study, particularly with respect to salt depletion.
Yeah, sure. Obviously, it was a phase I study, so both safety and efficacy were of interest to us. From a safety perspective with inhibition of angiotensinogen, one of the things to understand fully is if the blood pressure is lowered, whether that effect can be exaggerated if you then deplete the patient of salt. We did that specifically to see whether that would be safely tolerated by individuals, and it was. That's very reassuring preliminarily, this phase I study, that individuals who are on a drug like zilebesiran can withstand, you know, ordinary changes in their diet.
Issues going on in their health. It was essentially a test of safety, we're quite reassured by that. The other aspect, that, you know, we're interested in is if there is an excess effect, we can correct that readily with a saline infusion by giving salt and water back. I think it was a very comprehensive phase I study, both from an efficacy and safety viewpoint, we're very pleased with those results.
Great. It's maybe related to the obesity one, but maybe just a bigger picture question. As you keep pushing your technology into larger and larger indications, more prevalent patient populations, how do you think about what Alnylam wants to commercialize independently versus what represents a partnering opportunity?
You know, we're very fortunate to have this rich, diverse pipeline, as you say, having programs that address the needs of not just rare diseases but also more prevalent diseases. It gives us a lot of optionality. You know, we're able to progress the programs with investment that we have, and we've been very successful in progressing all of the programs under our control. You know, what we need to be open to as we think about entering some of these much larger diseases is what is the best way of really maximizing the benefits of these medicines for patients, but also the value that we create for the company.
you know, we'll keep progressing things, as we have done, but open to considering, the best value creation opportunities for, programs in our pipeline as they progress.
Great. I think our.
Jeff, is there anything you want to add?
No. I mean, I think you hit the nail on the head with the answer. It's a asset-by-asset assessment that we make in terms of how to maximize the value of the specific program.
Okay. We'll leave it there. Thank you, everyone.
Thank you.
Cheers.