MEI Pharma Inc (NASDAQ: MEIP) and Kyowa Kirin Co Ltd are discontinuing global development of zandelisib outside of Japan for B-cell malignancies.
Kyowa Kirin continues the ongoing clinical trials, including the Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas.
Recently, the companies reported topline data from a MIRAGE study demonstrating a 75.4% objective response rate, and 24.6% of patients achieved a complete response.
The move follows the most recent guidance from a late November meeting with the FDA that provided further guidance regarding the design and statistical analysis for the Phase 3 COASTAL trial.
The company believes the clinical development cannot be completed within a time supporting further investment.
In March, the FDA informed that a randomized clinical trial is "needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib."
Following the zandelisib update, MEI Pharma will focus on developing two earlier clinical-stage assets, voruciclib (B-cell malignancies) and ME-344 (solid tumors).
It plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce.
Following workforce reductions, MEI expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations through clinical data milestones for voruciclib and ME-344.
The company further announced that it had engaged Torreya Partners as a financial advisor to help explore additional strategic opportunities.
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