Aileron Therapeutics Announces Initiation of Expansion Cohort and First Patient Enrolled into Expansion Cohort of Phase 1b/2 Study of ALRN-6924 as a Chemoprotection Agent
WATERTOWN, Mass., May 27, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today the expansion of one of the dose levels in the dose optimization part of its Phase 1b/2
clinical trial evaluating ALRN-6924 as an agent to protect patients with small cell lung cancer (SCLC) against chemotherapy-induced toxicity, a concept known as chemoprotection (or
myelopreservation). The first patient has been enrolled into the expansion cohort, which was triggered by results from the ongoing trial that met protocol-specified criteria for expansion.
The Company expects to enroll approximately 8 patients into this dose optimization expansion cohort to further evaluate the selected dose for chemoprotection from topotecan-induced bone
"We recently reported completion of enrollment in the third and final dose level of the dose optimization part of the trial. Results emerging from the third dose level support the data observed with the previous two cohorts, where we observed a protective effect of ALRN-6924 for severe anemia and severe thrombocytopenia when compared to historical rates of those toxicities in SCLC patients treated with topotecan,” said Dr. Manuel Aivado, President and CEO of Aileron Therapeutics. "We are very excited about the prospects of being able to develop a treatment that could turn toxic chemotherapy into a form of well-tolerated, targeted therapy.”
The Phase 1b study is designed to identify a dose and a schedule of ALRN-6924 administration to reduce chemotherapy toxicities such as severe anemia and thrombocytopenia, and other toxicities resulting from topotecan. ALRN-6924 is administered 24 hours (in the dose optimization part) or six hours (in the schedule optimization part) before each dose of topotecan, which is administered daily on days 1 through 5 of every 21-day treatment cycle.
Aileron currently plans to report interim results for the dose optimization part of the trial in June 2020. The Company plans to report the top-line final data for the dose optimization part of the trial, including this expansion cohort, and data for the schedule optimization part of the trial in the fourth quarter of 2020. The Company expects that these results will determine a recommended ALRN-6924 dose and schedule for subsequent trials.