- MEI Pharma Inc 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.
- Price Action: MEIP shares are down 45.40% at $0.21 during the premarket session on the last check Tuesday.
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