SpringWorks Reports Positvie Topline Results For Mirdametinib From Phase 2b ReNeu Trial

(RTTNews) - SpringWorks Therapeutics, Inc. (SWTX), a clinical-stage biopharmaceutical company, Thursday announced positive topline results from the pivotal Phase 2b ReNeu study evaluating the company's drug candidate mirdametinib to treat neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Plexiform neurofibroma is a type of benign tumor that grow along nerves.

The ReNeu study enrolled 2 cohorts of patients-pediatric and adult with NF1-PN.

The primary endpoint was Confirmed Objective Response Rate (ORR), defined as 20% or more reduction in tumor volume assessed by Blinded Independent Central Review (BICR). As of September 20, 52% of pediatric patients and 41% of adult patients had BICR confirmed objective responses.

Additional data are expected to be presented at a medical conference in the first half of 2024.

SpringWorks said it plans to submit a New Drug Application (NDA) for mirdametinib to the FDA in the first half of 2024.