Aileron Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update - Seite 2

As previously reported, the Company was encouraged by the interim results of a data cutoff on January 22, 2020. In the first eleven patients across the first 2 dose levels tested, a protective effect of ALRN-6924 was observed for severe anemia and thrombocytopenia.  Based on the preliminary data from the Phase 1b trial, and historical rates of these toxicities in SCLC patients treated with topotecan, Aileron believes that ALRN-6924, when dosed before chemotherapy may have a chemoprotective effect on toxicities such as severe anemia and thrombocytopenia. 

Aileron has now completed enrollment of its final patient cohort of ALRN-6924 at a third dose level in the dose optimization part of the trial. The Company is encouraged with the initial data that is emerging from this cohort as it supports the trends observed with the previous two cohorts.

The Company plans to commence the schedule optimization part of the Phase 1b trial in June 2020. In this part of the trial, ALRN-6924 will be evaluated at up to two dose levels, potentially with an expansion cohort, in approximately up to 20 patients, and ALRN-6924 will be administered six hours before each dose of topotecan (on days 1 through 5 of every 21-day treatment cycle). The objective of the second dosing schedule is to determine if ALRN-6924 given six hours before topotecan has the potential to enhance the chemoprotection effects while also improving patient convenience by reducing the total number of days for infusion of ALRN-6924 and topotecan from six infusion days for the -24 hour schedule to five infusion days for the -6 hour schedule.

Aileron currently plans to report interim results for the three dose levels of the dose optimization part of the trial in the 2^nd quarter of 2020. The Company currently plans to report top-line final data for the dose optimization part of the trial 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.

The Company is monitoring carefully the effect of the coronavirus pandemic on the healthcare system and its clinical sites, which may impact the timing of these planned data announcements. 

First Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and investments as of March 31, 2020 were $12.7 million. In light of the Company’s cash resources and the uncertainties associated with the coronavirus pandemic, the Company has determined to focus its efforts on the development of ALRN-6924 as a chemoprotective agent, and does not plan to advance development of ALRN-6924 for any other program at this time.  The Company believes that its cash, cash equivalents and investments as of March 31, 2020 will be sufficient to fund its operations and capital expenditure requirements into the first quarter of 2021.