Arctic Bioscience — Earnings Release 2024

Oct 14, 2024

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

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.

For further information, please contact:

Christer L. Valderhaug

CEO

Mobile: +47 920 84 601

Email: christer@arctic-bioscience.com

About Arctic Bioscience

Arctic Bioscience is a biotech company developing and commercializing

pharmaceutical and nutraceutical products based on unique bioactive marine

compounds.

The company is developing HRO350 - a novel oral drug candidate. HRO350 is being

developed for treatment of patients with mild-to-moderate psoriasis. This is a

large patient group in need of new effective medicines with beneficial safety

profile.

Nutraceuticals from Arctic Bioscience are sold globally as bulk ingredients as

well as finished goods under the ROMEGA® brand.

Arctic Bioscience is led by a highly skilled team of talents with diverse and

highly relevant background.