Akari Therapeutics Announces Phase II COBALT trial of Coversin™ in Patients with PNH Met the Primary Endpoint
- Last three patients enrolled into the Phase II COBALT trial on the new dosing regimen (45 mg per Day) saw a more rapid decline in LDH than those in the original dosing regimen. The Day 28 Endpoint was less than or equal to 1.5 x ULN for all three patients.
- The new dosing regimen at 45 mg per day is expected to be used in the Phase III trials
- Company to host and webcast investor and analyst event
December 10, 2017, at 8:00 p.m. ET
The median LDH value of the last three patients enrolled, who utilised the higher 45mg dose, rapidly fell 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. In a total of 70 patient-months exposure, there have been no drug-related serious adverse events. In the eight patients in the COBALT Phase II trial, six were transfusion-dependent prior to the trial. Of those six patients, three have not required transfusions while on Coversin during the COBALT trial and during the Company’s long-term safety study, CONSERVE.
COBALT, the Phase II 90-day, open label single arm clinical trial is evaluating Coversin in patients with PNH who have never received a complement blocking therapy. All patients who have completed the Phase II COBALT trial entered the long-term safety study, CONSERVE. One patient in COBALT and one patient in CONSERVE with rising LDH levels were, as an alternative to higher dosing, moved as per protocol to twice daily dosing with a subsequent fall in LDH. The median LDH levels of the other three patients at Day 180 of CONSERVE was 1.77 times the ULN.
Under a separate Eculuzimab-resistent protocol, a ninth patient has been treated for 22 months with an average LDH level from month 2 onwards of 1.3 times the ULN.
“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.
“The 45 mg per day dosing of Coversin, as used for the last three patients recently enrolled into COBALT, saw plasma LDH levels in these patients fall rapidly to 1.5 times the ULN or below by Day 28,” said Principal Investigator
Akari plans to commence two Phase III PNH clinical trials with Coversin beginning with CAPSTONE in the first quarter of 2018, a Phase III trial that will include treatment naïve patients. The second Phase III trial, ASSET, is planned for the second half of 2018 and will include Soliris® switch patients.
Akari Therapeutics Investor & Analyst Event
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. Akari's lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long acting versions.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the
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Source: Akari Therapeutics Plc