Benzinga | Mar 2, 2021 07:23AM EST

Aileron Therapeutics Expands Enrollment Target For Upcoming Phase 1b Clinical Trial Of ALRN-6924 In Patients With Advanced Non-Small Cell Lung Cancer From 40 To 60 Patients

-- Placebo-controlled trial anticipated to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed --

-- Trial anticipated to begin in second quarter 2021 with initial data anticipated at the end of 2021 and final results mid-2022 --

-- Regulatory pathway now clarified for chemoprotection with recent U.S. FDA approval of first-generation chemoprotective drug for patients with extensive-stage small cell lung cancer1 --

-- ALRN-6924 is the first and only reported chemoprotective agent in clinical development to use a biomarker to ensure selective chemoprotection of healthy cells without protecting cancer cells --

WATERTOWN, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (NASDAQ:ALRN) today announced that it has expanded the enrollment target for its upcoming Phase 1b clinical trial of ALRN-6924 in patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy. Aileron plans to enroll 60 patients, increased from the original target of 40 patients, with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors). The company anticipates beginning to enroll patients in the trial in the second quarter of 2021. 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 novel concept known as chemoprotection.

"Last month, the field of chemoprotection took a giant step forward with the approval of the industry's first chemoprotection agent, which is approved to decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive small-cell lung cancer1. With this milestone, the regulatory path for chemoprotective agents like ALRN-6924 has now been clarified. ALRN-6924 is the first and only reported chemoprotective agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. This strategy is designed to selectively protect healthy cells in the body from chemotherapy while ensuring we do not protect cancer cells. As a result, healthy cells are spared from chemotherapeutic destruction while chemotherapy continues to kill cancer cells. Given the high prevalence of p53-mutated cancers, we believe ALRN-6924 could potentially benefit millions of patients worldwide," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron.