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Wired News – Akari’s Phase-II COBALT Trial of Coversin in Patients with PNH Met the Primary Endpoint

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LONDON, UK / ACCESSWIRE / December 12, 2017 / Active-Investors issued a free report on Akari Therapeutics, PLC (NASDAQ: AKTX), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=AKTX as the Company's latest news hit the wire. On December 08, 2017, the New York based biopharmaceutical Company announced that the Phase-II COBALT trial, assessing the Company's lead candidate CoversinTM in patients with paroxysmal nocturnal hemoglobinuria (PNH) met the primary endpoint of a significant reduction in serum LDH (lactate dehydrogenase) to ≤1.8 times the upper limit of normal (ULN) by day 28. Sign up now for our free research reports at:

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Progress of Phase-II COBALT Trial

Three additional patients were enrolled, together with the earlier five patients, into the COBALT, the Phase II 90-day, open label single arm clinical trial evaluating CoversinTM in patients with PNH who have never received a complement blocking therapy. The last three patients enrolled were treated with a revised dosing regimen of 45 mg every 24 hours. The median LDH value of the last three patients enrolled treated with higher 45mg dose, drop to 1.5 times the ULN at day 14 and below 1.5 times the ULN at day 28 and day 60, which was lower than the earlier patients on a 30mg dose who had a median LDH value of 2.2 times the ULN at day 28 and 1.7 times the ULN at day 60. No drug-related serious adverse events were observed.

Three of the six patients who were transfusion-dependent prior to the trial, did not require transfusions while on CoversinTM during the COBALT trial, and during the Company's long-term safety study, CONSERVE.

Akari to Progress into Phase-III Trials in Q1 2018 with Revised Dosing Regimen of 45 mg/day

Akari plans to commence two Phase-III PNH clinical trials with Coversin evaluating the revised dosing regimen of 45 mg in Q1 2018, as discussed with the US Food and Drug Administration (FDA) at a Type B End of Phase-II Meeting in September 2017.

CAPSTONE will assess the first Phase-III trial that will include treatment naïve patients. The second Phase-III trial, ASSET, is planned for the second half of 2018. The trial will include patients that switch from Alexion Pharmaceuticals' Soliris®. Soliris® is the first and only therapy approved for the treatment of patients with PNH to reduce hemolysis. Soliris® is approved for the treatment of patients with PNH in nearly 50 countries worldwide, including the United States, the European Union, and Japan.

What is Paroxysmal Nocturnal Hemoglobinuria?

Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, chronic, debilitating disease of the blood characterized by destruction of red blood cells, blood clots, and impaired bone marrow function. PNH is primarily a disease of younger adults and usually continuous throughout the life of the patient. The disease results in the death of approximately 50% of affected individuals, and until recently, had no specific therapy.

About CoversinTM

CoversinTM, Akari's lead product candidate, is a recombinant small protein derived from a protein discovered in the saliva of the Ornithodoros moubata tick. CoversinTM is a second-generation and potentially best-in-class complement inhibitor, acts on complement component-C5, preventing release of C5a and formation of C5b–9. Akari's initial clinical targets for CoversinTM are PNH and atypical Hemolytic Uremic Syndrome.

About Akari Therapeutics, PLC

Founded in 2005, Akari Therapeutics is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system, and the bioamine system for the treatment of rare and orphan diseases, in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression.

Stock Performance Snapshot

December 11, 2017 - At Monday's closing bell, Akari Therapeutics' stock dropped 4.90%, ending the trading session at $4.66.

Volume traded for the day: 1.86 million shares, which was above the 3-month average volume of 520.54 thousand shares.

Stock performance in the last month – up 9.65%

After yesterday's close, Akari Therapeutics' market cap was at $69.25 million.

The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry. This sector was up 0.3% at the end of the session.

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