SpringWorks Therapeutics Announces Full Enrollment of Phase 2b ReNeu Trial Evaluating Mirdametinib in Patients with NF1-PNs

Author: SpringWorks Therapeutics

Published On: 01/17/2022

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has achieved full enrollment in its Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). The study enrolled over 50 adults and over 50 pediatric patients with NF1-PN. SpringWorks expects to provide an update on anticipated ReNeu trial timelines and milestones at an upcoming company-sponsored R&D Day.

“Plexiform neurofibromas can cause severe disfigurement, pain, and functional impairment, and patients living with these devastating tumors are in need of new treatments. We are very pleased to have reached another important milestone on behalf of the NF1-PN patient community by completing enrollment in the ReNeu study,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We believe that mirdametinib has the potential to be a best-in-class treatment for NF1-PN based on its clinical activity, tolerability profile, ability to be taken without regard to food, and expected availability of a pediatric formulation. We look forward to providing further updates on the trial at our R&D Day.”

The ReNeu trial is a multi-center, open-label Phase 2b trial evaluating the efficacy, safety, and tolerability of mirdametinib in patients two years of age and older with an inoperable NF1-associated PN causing significant morbidity. Patients receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib is administered in a 3-week on, 1-week off dosing schedule. The primary endpoint of the ReNeu trial is objective response rate defined as ≥ 20% reduction in target tumor volume as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability measures, duration of response, and changes from baseline in patient reported outcomes. More information about the ReNeu trial is available at www.clinicaltrials.gov under the identifier NCT03962543.

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