Aileron Therapeutics Outlines Strategy To Strengthen Phase 1b Clinical Trial Of ALRN-6924 In Patients With p53-Mutated Breast Cancer

Author: Benzinga Newsdesk | August 01, 2022 07:52am

 

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 cancer

• Key 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, chemoprotection
  • New 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 2023
• Cash 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

 

Posted In: ALRN