A Phase 2 clinical trial, COBALT, assessing Akari Therapeutics' (NASDAQ:AKTX) lead candidate Coversin in patients with paroxysmal nocturnal hemoglobinuria (PNH) met the primary endpoint of a statistically significant reduction in LDH (lactate dehydrogenase) to within 1.8x the upper limit of normal (ULN) by day 28 (a reduction to within 2x of ULN within 28 days is considered successful).
The last three patients enrolled, treated with the higher dose of 45 mg, experienced a drop in LDH to 1.5x the ULN at day 14 and below 1.5x the ULN at day 28 and day 60. Subjects receiving the 30 mg dose showed a median LDH value of 2.2x the ULN at day 28 and 1.7x the ULN at day 60.
Half (n=3/6) of the transfusion-dependent patients at study entry did not a require transfusion while on Coversin therapy during COBALT or the long-term safety study.
Two Phase 3 studies evaluating the 45 mg/day dose should commence next quarter. CAPSTONE will assess Coversin in treatment-naive PNH patients and ASSET will include patients that will switch from Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab).
Coversin is a second-generation complement inhibitor.
Management will host an investor and analyst event on Sunday, December 10 at 8:00 pm ET.
Shares are up 1% after hours on light volume.
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