Akari Therapeutics NASDAQAKTX revealed that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has provided a positive opinion and recommended orphan drug status for its Coversin. The drug is for the treatment of Guillain Barré Syndrome (GBS).
According to Akari Therapeutics, Coversin, its lead clinical product, was a second-generation complement inhibitor acting on complement component-C5 thus preventing release of C5a, as well as, the formation of C5b-9, which was also called as the membrane attack complex or MAC.
The company’s CEO, Gur roshwalb, reacted to the developments to say, “We are pleased to receive this opinion from COMP, which is our first in Europe. The positive opinion underscores the continued need for the development of new therapies for GBS, where studies show that up to 35% of patients can have long-term neurological complications despite best care. We are excited by our continuing clinical advancement of Coversin and look forward to providing an update on the ongoing Phase Ib once daily subcutaneous multiple dose trial in June, as well as to initiating our Phase II trial in paroxysmal nocturnal hemoglobinuria this summer.”
Akari said Guillain Barré syndrome was an acute immune-mediated post infectious polyneuropathy where the immune system was triggered into attacking peripheral nerves, leading to progressive, fairly symmetric muscle weakness and paralysis accompanied by absent or depressed deep tendon reflexes. The company added that in animal models of GBS, Coversin was shown to provide protection against such effects.
The company said Orphan drug designation offered regulatory and financial incentives for it to develop and market therapies treating a life-threatening or chronically debilitating condition. Incidentally, it pointed out that no more than five in 10,000 persons in the EU were affected and that there was no satisfactory treatment available.