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Akari Therapeutics Announces Successful End-of-Phase II Meeting With FDA to Initiate Pivotal Phase III Study for Treatment of Bullous Pemphigoid With Nomacopan

Published: 2020-08-12 12:23:00 ET
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  • Phase III randomized placebo-controlled study in moderate to severe bullous pemphigoid (BP) patients with a primary endpoint of complete disease remission on minimal oral corticosteroids (OCS) agreed to with the FDA.  
  • Treatment arms will be tapered to minimal OCS and an important secondary endpoint is reduction in cumulative OCS on nomacopan as high dose OCS are regarded as unsafe in this vulnerable patient population.  
  • BP Phase III trial expected to start H1 2021  
  • Nomacopan has been granted orphan drug designation by theFDA and the EMA for the treatment of BP  
  • Nomacopan has potential to replace long term steroid treatment (standard of care) in BP, which has multiple adverse effects in this elderly and frail population

NEW YORK and LONDON, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces a successful End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding Akari’s proposed pivotal Phase III program for the treatment of BP.

The FDA has agreed to a two-part pivotal trial with Part A and Part B having the same structure, duration, endpoints and target population of moderate and severe BP patients.

In the Phase III study, patients will be randomized to receive either nomacopan plus oral corticosteroids (OCS) or placebo plus OCS. Following an initial stabilization phase, the steroids will be tapered according to disease response to a minimal level of OCS (<0.1mg/kg/d prednisone or equivalent) which is considered safe. If disease response is rapid, as was seen in the nomacopan Phase II study in patients with BP, OCS could be tapered to the minimal level within six weeks. The goal of conventional OCS tapering is to achieve minimal therapy (prednisone