Her er hele teksten:
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.
Ødelegger alle kreftstudier, siden plutselig alle er friskere enn forventet etter/under covid.