akariBy Mitchell Young

NEW YORK and LONDON: Akari Therapeutics, Plc [NASDAQ:AKTX], a biopharmaceutical company in clinical development of a drug competitive to Alexion Pharmaceuticals [NYSE: ALXN] flagship drug Soliris, announced that the Phase II COBALT trial of CoversinTM in paroxysmal nocturnal hemoglobinuria [PNH], met its primary goals.

Akari is a public company but tiny when compared to Alexion. Akari’s market capitalization is approximately $68 million, Alexion $24 billion.

Clinical trials for drugs competing with Alexion’s Soliris typically have very small patient enrollments. Akari’s trial consisted of a total of only 9 patients. New Haven’ Achillion Pharmaceuticals [ Nasdaq: ACHN] also has a drug in development to treat [PNH], and has met its goals in a Phase II trial as well.

“We are encouraged by the results from the Phase II trial, especially the lower mean LDH value observed in the last three patients enrolled into the trial treated with 45 mg daily compared to the patients treated with 30 mg daily,” commented Dr. David Solomon, Chief Executive Officer of Akari Therapeutics.

Solomon added, “we are on track to progress into Phase III clinical trials in the first quarter of 2018 with the revised dosing regimen of 45 mg, as discussed with the FDA.”

According to the company, “the Phase II data suggest that Coversin is a potential alternative to existing therapy for patients with PNH, and could allow independence from intravenous infusions through self-administration.”

Soliris is administered via infusion, Alexion announced a licensing deal with Halozyme Therapeutics, Inc. [Nasdaq:HALO] of San , technology that will allow Alexions Soliris replacement drug ALXN1210 [ in clinical trials] to also be available to patients by self-administration without infusion, [see licensing].

Akaris expects it Phase III trial will include patients that have not been treated with Soliris as well as patients that have been on the Alexion drug. Alexion’s Soliris generates more than $3 billion annually in sales and at more than $440,000 per patient per year is considered the most expensive drug on the market today.

In reporting last week the New York Times disclosed  that activist investor Elliot Management is seeking changes to Alexion’s board and a revised strategic plan, [see Activist Investor Targets Alexion].