- Gur Roshwalb, Akari Therapeutics' CEO, has stepped down following a month or more on administrative leave, with Ray Prudo, executive chair, taking over on a temporary basis.
- This follows the release of a press release stating (incorrectly) that a fifth patient, who was withdrawn from the trial prematurely, had met the primary endpoint of the paroxysmal nocturnal hemoglobinuria (PNH) study. The data was also related in a now withdrawn report issued by Edison Investment Research, a company retained by Akari to produce research reports. Akari confirmed in a press release on Tuesday that the patient did not actually meet the primary endpoint.
- A search is ongoing for a new CEO, and further data on the Phase 2 PNH trial will be released in about four weeks. Akira's stock has slid by over 70% since the release of the interim results, from $20.15 to $6.13 at close of market yesterday.
They say that the truth hurts. Well, it certainly does for Gur Roshwalb, the (ex-)CEO at Akari Therapeutics, who has stepped down following the scandal over the misreported data.
The incorrect interim results came from a press release published on April 24, 2017. The release stated that "A fifth patient with an LDH of 3.7 X ULN [upper limit of normal] at baseline achieved the primary endpoint at day 14, but was withdrawn from the trial at day 43 due to a suspected co-morbidity unrelated to treatment, which would have excluded the patient from the trial protocol. While on Coversin, the patient met the primary endpoint (day 14), and achieved and maintained a CH50 <LLQ (day 1) but clinical response fluctuated and did not stabilize."
The news of the Edison report withdrawal broke in a press release issued on April 27. Following an internal review, it appears that Edison's report was reviewed and approved by now disgraced CEO Gur Roshwalb, which Akari states firmly was "in contravention of company policy."
Akari and members of its management may now be subject to governmental investigations and proceedings, relating to both the Edison report and the release, and two putative class actions against Gur Roshwalb and CFO Dov Elefant have been filed, seeking unspecified damages, costs and fees.
This has all rather overshadowed the results in the four patients who did complete the five-patient Phase 2 safety, efficacy and dose-ranging study. These individuals self-administered Coversin twice-daily for a month and then once daily. These patients met the primary endpoint of reductions in serum LDH of 1.8 x ULN or lower. The company has previously stated that it expects to begin a Phase 3 trial in the fourth quarter of 2017, and it's not clear whether this will be affected by the misrepresentation of data.