Akari Therapeutics’ (NASDAQ:AKTX) nomacopan met its primary safety and secondary efficacy endpoints in a Phase 2 trial of patients with bullous pemphigoid (BP).
BP is a severe orphan inflammatory skin disease characterized by chronic blistering of the skin. It is currently treated with steroids and immunosuppressants, but relapses frequently occur.
The trial achieved its primary safety endpoint, with no reports of grade 3, 4 or 5 treatment-related adverse events. It also achieved its secondary efficacy endpoint of a clinically significant improvement in the Bullous Pemphigoid Disease Area Index. The average decline in the index for all nine patients was approximately 40% at day 42.
“Clinicians continue to seek an effective treatment for BP that can be administered in outpatient settings and minimize the use of steroids, which often cause significant clinical complications in this at-risk population,” Dr. Christian Sadik, the trial’s lead investigator, said in a statement.
“I am therefore delighted by the promising results of Akari’s Phase 2 trial in BP which shows rapid efficacy, similar to potent steroids, but with the advantage of being well tolerated, and possessing a good safety profile,” he added.
Akari plans to meet with the FDA and the European Medicines Agency to discuss its pivotal trial design in third quarter 2020.
