Hi, and welcome to this webcast from Arctic Bioscience. My name is Christer Valderhaug, the CEO, and with me today is our medical director, Runhild Gammelsæter. The topic today is the results from the six-month readout of the HeROPA study. The ongoing phase IIb HeROPA trial is a 52-week trial with 521 patients recruited. The trial is studying the efficacy and safety of HRO350 in mild to moderate psoriasis. The primary endpoint, meaning PASI 50 at 26 weeks, was not met, mainly due to a higher-than-expected placebo response. Secondary endpoints at week 52 will be critical to understand the potential of HRO350 and its long-term efficacy and safety in mild to moderate psoriasis. I will now hand it over to Runhild to elaborate more around HRO350 and the readout results.
Thank you very much, Christer. HRO350 is a unique novel oral drug candidate in clinical development for the treatment of mild to moderate psoriasis, and it's currently in a phase IIb clinical trial. The active pharmaceutical ingredient is PEs, phospholipid esters from herring roe, and these polar lipids have a number of biologically active metabolites, which we've been exploring in a research project supported by a grant from the Norwegian Research Council. This includes data on specialized pro-resolving mediators, SPMs, endogenous bioactive lipids, which promote resolution of inflammation, and these lipid mediators have previously been shown to have a role in psoriasis, where they can impact key cytokine pathways, driving the inflammation, which is a hallmark of psoriasis. When primary immune cells, which been pretreated to be inflamed, so they're mimicking psoriasis, are treated with HRO350, they produce SPMs involved in the resolution of inflammation.
These findings elucidate a potential mode of action of HRO350 and support an anti-inflammatory effect, which could include activating key SPM pathways. This could be a promising treatment modality in inflammatory conditions, including psoriasis. Resolution of inflammation, also called immunoresolution, is a therapeutic frontier. SPMs are key in promoting the resolution of inflammation. Figure one shows how inflammation in the body involves a required increase in cytokines. However, this should naturally be resolved by a shift in the involved cell types, resolving that inflammation. If this natural resolution does not occur, as shown in figure two, a chronic inflammatory state can follow. Today, most treatment modalities for chronic inflammatory diseases like psoriasis involve reducing the inflammation by, for example, inhibiting cytokines. There is currently ongoing a lot of research in how to promote natural resolution of inflammation.
And at the EADV Congress in September, we presented data on anti-psoriatic effects of herring roe oil in immune cells and skin cells. And this cellular research supports an anti-psoriatic mechanism of HRO350, and it shows that phospholipid esters from herring roe can have immunomodulatory anti-psoriatic effects by affecting signaling on the IL-17/IL-23 axis in both immune cells and psoriatic skin cell models. So HRO350 is currently being investigated in mild to moderate psoriasis, and the HeROPA trial is a phase IIb study with a one-year placebo-controlled period. And there are three treatment arms, two doses of HRO350 versus placebo. And the HeROPA trial was fully recruited, with 521 patients randomized early this year, and we had a sufficient number of patients completing six months of treatment to analyze the primary endpoint as planned.
That primary endpoint is set at six months of treatment, and that's indicated in point one in this figure. The study will continue until all patients have completed one year of placebo-controlled treatment, point two in the figure, where secondary endpoints will be assessed. The rationale for a one-year placebo-controlled period was that the pilot clinical trial on HRO, which was conducted at Haukeland, showed an effect at 26 weeks, which improved further over time. The primary endpoint in the HeROPA trial is PASI 50, and that measures the proportion of patients with a 50% reduction in the psoriasis area and severity index after 26 weeks of treatment versus placebo. A number of secondary endpoints are set at 52 weeks, and that includes new PASI assessments, patient-reported outcomes, and of course, safety.
All the patients in the HeROPA trial have passed six months of treatment, and the primary endpoint has been read out as planned. The results show that the response rate in the HRO350 high dose group was close to the estimated effect level. However, the number of patients with PASI 50 response in the placebo group was higher than predicted, and thus, there was no statistically significant difference from placebo. Of note, there have been no safety concerns so far in the HeROPA trial, and no unexpected serious events related to the study medication have been reported to date. Now, I would like to express my gratitude to the patients and investigators participating in the HeROPA trial, and because the study is still ongoing, we're not disclosing numeric details on the results until the study is complete.
The high placebo rate in this trial, it was surprising, and it warrants further investigation. It's known that placebo rates in mild and fluctuating diseases can be high. Analyzing data after one year of treatment will give further information on potential seasonal and yearly fluctuations in the patients. We hope that the 52-week data can provide further answers on effect rate versus placebo, and also to document the safety of HRO350, and I'll now hand back over to Christer to talk about the way forward.
Thank you, Runhild. From a patient perspective, HRO350 still has the potential as an oral treatment option in mild to moderate psoriasis, with a new mode of action and based on natural raw material. Data after 52 weeks of treatment will give further information about the benefit-risk profile of HRO350, as well as long-term treatment results versus placebo in a population with fluctuating disease. As Runhild mentioned, there has been no safety concerns so far in the HeROPA trial, and no unexpected serious events related to the study medication. Going forward, we need to analyze 52-week data to look at long-term outcomes of HRO350 versus placebo in this patient population. Additionally, the planning of a phase III clinical trial will temporarily be put on hold until 52-week data are evaluated.
We will also put on hold establishing a drug manufacturing line until the further drug development program for HRO350 is clarified. Commercially, we will explore potential alternative routes to market for HRO350. For example, a non-prescription route. On the financial side, the liquidity situation has been closely monitored over time, and various financing alternatives are being considered to secure the future funding of the company's activities post the primary data readout. Cash preservation initiatives are implemented to ensure available financial resources into 2025, enabling upcoming key inflection points in Q1. We will also perform a full strategic and organizational assessment to secure a sustainable financial platform going forward. Finally, the company expects to continue delivering double-digit annual nutra revenue growth towards profitability in 12 to 18 months. With that, we are rounding off our presentation.
If you have any follow-up questions, please contact either Runhild or myself. Thank you very much for the attention.