Aileron Therapeutics (NASDAQ:ALRN) has announced the commencement of the expansion of dose levels in its Phase 1b/2 dose optimization clinical study evaluation of ALRN-6924 as a protection agent for small cell lung cancer patients against toxicity resulting from chemotherapy.
Aileron to enroll eight patients in cohort expansion
The company has started the expansion cohort and enrolled the first patient. Results from the ongoing trials triggered the expansion of the cohort since the results met specified protocol criteria for the expansion. Aileron is now expecting to enroll around eight patients in the expansion of dose optimization for further evaluation of the selected dose for myelopreservation against topotecan-brought bone marrow toxicities.
Manuel Aivado, the CEO and President of Aileron Therapeutics, indicated that the company recently completed the third and last dose level enrolment for the dose optimization study. The CEO added that so far, results from the third dose level are consistent with previous data observed in the two cohorts. The company observed ALRN-6924’s protective effect in severe thrombocytopenia and severe anemia relative o previous toxicity rates in topotecan-treated SCLC patients. Aivado added that the company was excited by the prospects of developing a treatment that is likely to change toxic chemotherapy into a well-tolerated targeted therapy.
Dose optimization study to guide subsequent trials
Aileron has designed a Phase 1b trial to identify a schedule and dose of ALRN-6924 that can be administered to minimize chemo toxicities like severe thrombocytopenia, anemia, and others that can result from topotecan treatment. In the dose optimization, part ALRN-6924 is given 24 hours, or in the schedule optimization it is given 6 hours before every topotecan dose
Currently, the company is planning to provide interim data for the dose optimization trial part in June 2002. Similarly, Aileron will report top-line final results of the dose optimization trial part that includes cohort expansion, as well as data for schedule optimization trial part in Q4 2020. The company is optimistic that data from the studies will help determine the accepted ALRN-6924 dose and the schedule for subsequent studies.