Clinical Development

ALRN-6924 Clinical Development Status

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.


Proof-of-Concept Clinical Results from Ongoing ALRN-6924 Phase 1b Trial

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 and here for press release.)


Upcoming Milestones

We continue to enroll patients in a schedule optimization part of the Phase 1b trial intended to determine whether ALRN-6924 given six hours prior to topotecan could be an alternative dosing schedule that could provide patients and healthcare providers with additional flexibility of when to administer ALRN-6924 before topotecan. We expect to report final results from the Phase 1b trial, including data from the 6 hour-schedule, in the first quarter of 2021.

We expect to initiate registration programs for ALRN-6924 in non-small cell lung cancer in the second half of 2021 and in a gastrointestinal cancer indication in 2022, subject to the results of a healthy volunteer study planned to initiate in the fourth quarter of 2020, and the final data from the Phase 1b study expected in the first quarter of 2021.


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