Akari Therapeutics’ Phase II trial investigating Coversin (nomacopan) in mild-to-moderate bullous pemphigoid has so far enrolled seven out of its nine-patient target as of three to four weeks ago, a source with knowledge of the trial said. The trial was aimed to complete within six months but it is still enrolling in its eighth month, the source noted, adding it is hoped the final two patients would be recruited in the next couple of months.
ClinicalTrials.gov shows the six-week, open-label Phase II trial (NCT04035733) is still enrolling from one site in Germany and another in the Netherlands. But the source noted there are five sites in Germany and two sites in the Netherlands. The last enrolment update for this trial was made by Akari on 23 April via a media release, when it announced data from the first three patients.
Bullous pemphigoid is a rare skin condition seen in elderly patients, which in general makes it harder to recruit for clinical trials, the source said. Another potential reason for the enrolment delay is the time needed to finalise contracts between Akari and the trial sites, he added.
ClinicalTrials.gov shows the trial has a 25 September 2018 actual study start date, with an estimated primary completion date of 19 September 2019. In a 31 July media release, Akari announced it will have a Phase II oral presentation at this year’s European Academy of Dermatology and Venereology (EADV) Congress. The Congress will be in Madrid, Spain in October 9–13, 2019.
Data from the first three patients show that these patients’ Bullous Pemphigoid Disease Area Index (BPDAI) scores—the trial’s primary endpoint—fell 31% from baseline on day seven, 45% on day 21, and 52% on day 42, as per the April media release. Nomacopan, dosed once daily subcutaneously, was well-tolerated in the three patients and there were no drug-related adverse events reported, it states.
Nomacopan works by inhibiting terminal complement activation C5 and the lipid mediator leukotriene B4, thought to be relevant in bullous pemphigoid, the company website shows. Bullous pemphigoid’s primary symptom is large, fluid-filled blisters on the skin by the lower abdomen, upper thighs, and armpits.
Akari, which has a market cap of $3.4bn, did not respond to request for comment.