Shots:

• The company has completed enrolment in the P-IIb ReNeu trial to evaluate mirdametinib in 50 adults & ~50 pediatric patients aged 2yrs. with NF1-associated plexiform neurofibromas (NF1-PN)
• The 1EPs of the trial is ORR with ≥ 20% reduction in target tumor volume as measured by MRI & assessed by BICR while 2EPs include safety, tolerability, DoR & changes from baseline in PROs. As of  Mar 23, 2021  cutoff date, 50% of patients had achieved an ORR as assessed by BICR, 80% remained on study & median time on treatment was ~12mos.
• Mirdametinib is an oral, allosteric small molecule MEK inhibitor & has received ODD from the US FDA & EC for NF1 & FTD from the US FDA for NF1-PN patients aged ≥2yrs.

 Ref: Globenewswire | Image: SpringWorks