We are currently underway with a proof-of-concept Phase 1b study evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced bone marrow toxicities, such as severe anemia, thrombocytopenia and neutropenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan.
In October, we announced new positive clinical results from our ongoing Phase 1b trial demonstrating that treatment with ALRN-6924 24 hours prior to second-line topotecan administration resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated small cell lung cancer (SCLC). With these data, ALRN-6924 has achieved clinical proof of concept. The results were featured in a late-breaking poster presentation entitled, “Prevention of Chemotherapy-induced Myelosuppression in SCLC Patients Treated with Dual MDM2/MDMX Inhibitor ALRN-6924” at the 32nd EORTC-NCI-AACR Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics. (Link here for poster)
In the second quarter of 2021, we plan to begin enrollment in a Phase 1b randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with advanced non-small cell lung cancer (NSCLC) undergoing treatment with first-line carboplatin doublet chemotherapy (with or without immune checkpoint inhibitors). This trial, which will advance ALRN-6924 into a large cancer indication, represents a key step toward advancing our vision to bring chemoprotection to all patients with p53-mutant cancer regardless of cancer type or chemotherapy.
In 2021, we also plan to report additional results from our ongoing Phase 1b clinical trial in patients with SCLC. The data set, which we plan to announce in the first quarter of 2021, will include results across all dose levels evaluating ALRN-6924 administered 24 hours prior to topotecan administration (“24-hr schedule”), including an exploratory 0.2 mg/kg dose level, as well as results from a cohort evaluating 0.3 mg/kg ALRN-6924 administered six hours prior to topotecan administration (“6-hr schedule”), which has now completed enrollment, with a total of six patients.
In addition, we initiated a healthy volunteer study in November 2020 to characterize the time to onset, and magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Due to COVID-19-related delays, we have updating our guidance on the readout of the healthy volunteer study from the second quarter of 2021 to mid-2021.
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