We are currently underway with a proof-of-concept Phase 1b study evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced bone marrow toxicities, such as severe anemia, thrombocytopenia and neutropenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan.
The protocol for this study consists of a phase 1b and a randomized, controlled phase 2; the Phase 1b has two parts: dose optimization and schedule optimization.
In June 2020, we announced positive interim data from the dose optimization part of the Phase 1b study demonstrating that treatment with ALRN-6924 resulted in protective effects against severe chemotherapy-induced anemia and thrombocytopenia in patients across three dose levels (0.3, 0.6, and 1.2 mg/kg) relative to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 also met the protocol-defined criterion for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle, triggering a cohort expansion at this dose level, from six to 14 patients. In August 2020, we announced the completion of enrollment in the cohort expansion.
In the fourth quarter of 2020, we plan to initiate enrollment in a healthy volunteer study to determine dosing schedules for ALRN-6924 that will support and further de-risk the company’s long-term vision to provide a chemoprotective medicine for patients with a p53-mutation regardless of cancer type or chemotherapeutic drug.
We also plan to report final Phase 1b dose optimization data in the fourth quarter of 2020, including data from the dose optimization expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data, in addition to preliminary Phase 1b schedule optimization data.
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