Akari Therapeutics (AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced Monday that it has received positive opinion for Orphan Drug Designation for Coversin in the European Union for treatment of Guillain Barré Syndrome.
The European Medicines Agency or EMA Committee for Orphan Medicinal Products has issued a positive opinion recommending orphan drug designation for Coversin. Akari's lead clinical product is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9, also known as the membrane attack complex or MAC.
Guillain Barré syndrome is an acute immune-mediated post infectious polyneuropathy where the immune system is triggered into attacking peripheral nerves, leading to progressive, fairly symmetric muscle weakness and paralysis accompanied by absent or depressed deep tendon reflexes.
In animal models of GBS, Coversin has been shown to provide protection against such effects.
Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available.
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