Arctic Bioscience - Announces top-line results from the phase 2b HeROPA study

All patients have passed 6 months of treatment in the HeROPA phase 2b clinical study, which compared HRO350 to placebo. While the high dose active treatment arm showed an effect close to the assumed effect level, the placebo rate was unexpectedly high, preventing the achievement of the primary end-point. The HeROPA study is still ongoing and placebo controlled for 52 weeks.

"We have strong confidence in our phospholipid-based technology platform for resolving inflammation. The study is still ongoing, and the promising effects observed in the treatment arm at the 6-month read-out are encouraging. This is a 52-week trial, and based on prior clinical studies, we know that HRO350 has time to onset of effect”, says CEO Christer L. Valderhaug.

Arctic Bioscience will continue investigating the data in collaboration with its Contract Research Organization (Smerud Medical Research International) to identify the reasons behind the unexpectedly high placebo rate. Mild-to-moderate psoriasis is a fluctuating disease where patients can experience spontaneous improvements, and the disease is often less severe during the summer, due to sunlight exposure. Thus, endpoints analyzed after 52 weeks of treatment may elucidate how disease fluctuation over a full year may have impacted the 26-week primary endpoint. Of note, there have been no safety concerns, and no unexpected serious events related to the study medication have been reported to date.

“We will investigate deeper into the data from the 6-month read-out, while the study proceeds with 12-months of treatment. Our aim is to provide an oral treatment option for patients, and to that end we have carefully and pro-actively explored alternative regulatory and go-to-market strategies, which we will assess as new insights emerge. The data shows potential, and once we have completed more detailed analyses, we will decide on the course we believe offers the greatest potential moving forward”, says CEO Christer L. Valderhaug.

PASI50 (50% improvement in PASI score) was chosen as primary endpoint to align with regulatory guidelines on clinical studies in psoriasis. The study is still ongoing, thus numeric data are not disclosed at this time.

“The high placebo rate in this trial was surprising and warrants further investigation. Data from our previous study showed a statistically significant improvement over placebo in the same patient population, and we also have cellular studies showing anti-inflammatory effects of HRO350 with relevance in psoriasis. We are grateful to the patients and investigators participating in the HeROPA trial, and hope that 52-week data may provide further answers on effect rate versus placebo and document safety”, says Medical Director Runhild Gammelsæter.

Arctic Bioscience will continue the global market expansion of its nutraceutical pipeline where we see a significant growth potential. The company will also perform a full strategic and organizational assessment to secure a sustainable financial platform. Cash preservation initiatives will be put in place to ensure that available financial resources enable the company to complete the 12-month study and continue product development, regardless of the strategic direction taken.

CEO Christer Valderhaug and Medical Director Runhild Gammelsæter, will present the findings of the study and the next steps during a webcast on Wednesday, October 16th, at 12:00 CET. A separate invitation will be published at Newsweb.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act. This stock exchange announcement was published by Jone R. Slinning, CFO at Arctic Bioscience AS, on the date and time as set out above.