Corporate News Blog - Akari Therapeutics Announces Enrolment of Additional Patients in COBALT Phase-II Clinical Trial of Coversin(TM)
LONDON, UK / ACCESSWIRE / October 13, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Akari Therapeutics, PLC (NASDAQ: AKTX) ("Akari"), following which, we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=AKTX. The Company announced on October 11, 2017, the enrolment of three additional patients in the ongoing Phase-II COBALT clinical trial of Coversin™ in patients with paroxysmal nocturnal hemoglobinuria (PNH). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Progress of COBALT Phase-II Clinical Trial
Out of the eight patients enrolled in COBALT, the Phase-II 90-day, open label single arm clinical trial, four have completed the trial and have all moved into Akari's long-term safety study, CONSERVE. The data was presented at the 22nd Congress of the European Hematology Association (EHA) in June 2017. One of the initial five patients enrolled was withdrawn from the study on day 43.
Pursuant to an amended protocol based on a revised dosing regimen, three new patients were enrolled, who have now completed approximately 8, 3, and 2 weeks, respectively. The first of the three patients had an LDH (lactate dehydrogenase) value of 1.5 times the ULN at day 28, meeting the primary endpoint of serum LDH reduction to ≤1.8 times the ULN. The other two patients have not yet reached the primary endpoint measurement date. No drug-related serious adverse events were reported.
Akari Announces Regulatory Progress Following FDA Meeting
Following advice of United States Food and Drug Administration (FDA), the Company plans to advance Coversin™ towards Phase-III clinical trials, beginning with CAPSTONE in Q1 2018, a Phase-III clinical trial of Coversin™ in naïve PNH patients.
Akari Demonstrated Positive Response with Coversin™ in Phase-2 PNH Trial
On April 24, 2017, Akari presented data from an interim analysis of its Phase-2 trial of Coversin™ in PNH, as well as preclinical data for additional indications and other opportunities, at Research and Development Day. The Company demonstrated positive response from the trial.
About Coversin™
Coversin™ is Akari's lead product candidate. It is a recombinant small protein derived from a protein discovered in the saliva of the Ornithodoros moubata tick. Coversin™ 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 Coversin™ are PNH and atypical Hemolytic Uremic Syndrome. To date, the Company has demonstrated full complement inhibition and marked lactate dehydrogenase reduction in a PNH patient with eculizumab resistance.
About Paroxysmal Nocturnal Hemoglobinuria (PNH)
PNH is a rare, chronic, debilitating disorder that most frequently presents in early adulthood and usually continues throughout the life of the patient. PNH results in the death of approximately 50% of affected individuals due to thrombotic complications, and until recently, had no specific therapy.
About Akari Therapeutics, Plc (NASDAQ: AKTX)
Founded in 2005, Akari 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. The Company is based in New York City, New York.
Last Close Stock Review
On Thursday, October 12, 2017, the stock closed the trading session at $6.96, dropping 5.95% from its previous closing price of $7.40. A total volume of 310.94 thousand shares have exchanged hands. Akari Therapeutics' stock price skyrocketed 7.24% in the last one month and 52.97% in the past three months. The stock currently has a market cap of $83.31 million.
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