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Aileron Therapeutics Is Pleased to Outline Strategy to Strengthen Phase 1b Clinical Trial of ALRN-6924 in Patients with p53-Mutated Breast Cancer
Enhancements to protocol, informed by recent ALRN-6924 data, are designed to improve the opportunity to demonstrate protection against chemotherapy-induced
About this update from Rein Therapeutics, Inc.
[{"type":"text","content":"Enhancements to protocol, informed by recent ALRN-6924 data, are designed to improve the opportunity to demonstrate protection against chemotherapy-induced severe neutropenia, alopecia (hair loss) and potentially other toxicities in patients with p53-mutated breast cancerKey protocol enhancements include: Selection of 1.2 mg/kg dose of ALRN-6924 with the goal to extend duration of cell cycle arrest and, thus, chemoprotectionNew primary endpoint that is more closely aligned with regulatory precedents for approved supportive care products Planned readouts include: data from initial patients in 4Q 2022; interim analysis on 12 patients in 2Q 2023; and topline results from 20 patients in 3Q 2023Cash runway has been extended; now expected to fund operations through end of 1Q 2024, including Phase 1b trial topline results and preparations for a pivotal trial, pending breast cancer trial data BOSTON, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, today outlined its strategy to strengthen the company’s Phase 1b chemoprotection trial of ALRN-6924 in patients with p53-mutated breast cancer. The Phase 1b, open-label, single-armi, multicenter trial is designed to evaluate the safety, tolerability and chemoprotective effect of ALRN-6924 in up to 24 patients with p53-mutated breast cancer undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. The primary endpoints are duration and incidence of severe neutropenia (Grade 4) in cycle 1. Secondary endpoints include the chemoprotective effect of ALRN-6924 on chemotherapy-induced alopecia, as well as other hematologic and non-hematologic toxicities. TAC will be administered every 3 weeks for 4 to 6 cycles based on investigators’ discretion. ALRN-6924 will be administered at 1.2 mg/kg on 3 consecutive days in each treatment cycle, Days 0, 1 and 2, while chemotherapy will be administered on Day 1. “Our team has worked methodically and expeditiously to modify the Phase 1b breast cancer trial in order to enhance our opportunity to demonstrate a robust chemoprotective effect of ALRN-6924 in patients with p53-mutated breast cancer. The evidence-based modifications we are implementing ref...