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Aileron Therapeutics Announces Completion of Enrollment in Dose Optimization Expansion Cohort of Proof-of-Concept Phase 1b Study of ALRN-6924
Study is evaluating ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC)
About this update from Rein Therapeutics, Inc.
[{"type":"text","content":"Study is evaluating ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC) treated with topotecanPreviously reported positive interim data from dose optimization part of study demonstrated 0.3 mg/kg dose of ALRN-6924, now being evaluated in expansion cohort, resulted in most robust chemoprotective effectsData readouts anticipated in Q4 2020: Final dose optimization data, including data from expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data; preliminary data from recently initiated schedule optimization part of study WATERTOWN, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today that it has completed enrollment in the dose optimization expansion cohort of its ongoing open-label Phase 1b clinical study of ALRN-6924. Aileron is focused on transforming the experience of chemotherapy for cancer patients by developing and delivering a novel chemoprotective medicine to protect against multiple chemotherapy-induced side effects. The proof-of-concept Phase 1b study is 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.\n “We’re very encouraged by the data we reported from the dose optimization part of the Phase 1b in June demonstrating ALRN-6924’s potential to shield multiple healthy cell types from chemotherapy-induced damage without limiting the effect of chemotherapy on cancer cells,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. “Per the interim findings, the 0.3 mg/kg dose of ALRN-6924 achieved the most robust and consistent chemoprotective effects of the three dose levels evaluated. The chemoprotection results were further supported by pharmacodynamic biomarker results also observed in the interim analysis.” Dr. Aivado continued, “We look forward to reporting the final results of the dose optimization part of the Phase 1b, including findings from the 0.3 mg/kg e...