Aileron Therapeutics Inc. (NASDAQ:ALRN) has announced positive preliminary results of the company’s dose optimization portion of Phase 1b open-label trial of the continuing Phase1b/2 clinical study.
Study results show ALRN-6924 can offer chemoprotective effects
The company is evaluating ALRN-6924 in the ongoing study as an agent that can protect patients against toxicity resulting from chemotherapy, a concept called chemoprotection or myelopreservations. Participants in the study had advanced mutated small cell lung cancer and received second-line topotecan treatment after ALRN-6924 administration. The study enrolled 18 participants across the three dose levels of ALRN-6924 in the part of dose optimization in the study. Out of the 18 participants, 17 finished the first treatment round and, as a result, met the protocol-defined evaluability criteria.
Results showed there was a protective outcome against severe anemia induced by chemotherapy as well as thrombocytopenia in all does levels relative to past controls. Similarly, patients that received 0.3mg/kg of ALRN-6924 attained the protocol-defined reduction criteria for NCI CTC Grade 3/4 neutropenia in the first round of treatment.
Preliminary study results showing a positive outcome
Chief medical officer, Vojo Vukovic indicated that the trials designed for evaluation of topotecan anti-tumor efficacy. While other drugs have been showing safety data, with adverse effects on hematology toxicity. Vukovic indicated that in the current Aileron study, they are evaluating bone marrow toxicity depending on lab values that are objective measures when looking at topotecan toxicity. The preliminary results demonstrate robust chemoprotective outcomes on patients with severe thrombocytopenia, and anemia; that receive topotecan treatment.
Aileron CEO and President Manuel Aivado stated that they were pleased with the chemoprotective effect shown by ALRN-6924 in the dose optimization section of the current trial in patients with SCLC. Aivado added that from the preliminary data of the 17 patients as well as published singe-agent rates of topotecan associated toxicities in the second line, SCLC patients believe that ALRN-6924 can offer chemoprotective effects.