Benzinga | Jul 1, 2021 08:06AM EDT

Aileron Therapeutics Announces Initiation Of Randomized, Double-Blind, Placebo-Controlled Trial Of ALRN-6924 In Patients With Advanced Non-Small Cell Lung Cancer

* Phase 1b trial anticipated to enroll 60 patients with advanced p53-mutated NSCLC undergoing chemotherapy with first-line carboplatin plus pemetrexed

* Study will evaluate proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life

* First interim safety data anticipated at the end of 2021 and final results mid-2022

* ALRN-6924 uses p53 mutation as biomarker to ensure selective chemoprotection of healthy cells without protecting cancer cells

* Nearly 1 million patients in the U.S. are diagnosed every year with p53-mutated cancer, including half of the approximately 190,000 NSCLC patients diagnosed in the U.S., annually1

* Aileron plans to ultimately pursue a tumor-agnostic indication for ALRN-6924 as chemoprotective agent for patients with p53-mutated cancer regardless of type of cancer or chemotherapy

BOSTON, July 01, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (NASDAQ:ALRN) today announced that it has initiated a randomized, double-blind, placebo-controlled clinical trial in the US and in Europe of ALRN-6924 as a chemoprotective agent to treat patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors in this Phase 1b trial. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy's attack on cancer cells, a concept known as chemoprotection.

"We are pleased to initiate this trial, which builds on promising data we previously reported from our proof-of-concept trial of ALRN-6924 in patients with small cell lung cancer (SCLC)," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "This NSCLC trial represents important progress in our clinical development strategy, as it involves a p53-mutated cancer indication that affects one of the largest cancer patient populations, and it is our first randomized, double-blind, placebo-controlled trial. In addition, the trial is designed to help us further advance our ultimate goal of pursuing a tumor-agnostic indication for ALRN-6924 as a chemoprotective agent for patients with p53-mutated cancers regardless of type of cancer or chemotherapy, with the potential to help millions of patients."