Reneo Pharmaceuticals has achieved its target enrolment in the Phase IIb STRIDE trial of its potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist mavodelpar (REN001) to treat primary mitochondrial myopathies (PMM).
The international, double-blind, randomised, placebo-controlled pivotal trial is designed to evaluate mavodelpar in adult patients with PMM due to mitochondrial (mtDNA) defects.
It will assess the safety and efficacy of mavodelpar administered at 100mg orally, once-a-day, for 24 weeks.
The change from baseline in the distance walked during the walk test for 12 minutes at week 24 is the trial’s primary efficacy endpoint.
Reneo Pharmaceuticals president and CEO Gregory Flesher said: “We are very pleased to announce the dosing of the 200th patient in the ongoing Stride study.
“We achieved our target enrollment and have several pending patients that are awaiting their baseline visit. As such, we anticipate a total enrollment of more than 200 patients and topline results in the fourth quarter of 2023.
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“We are also pleased to see that approximately 85% of the eligible patients from STRIDE have opted to participate in STRIDE AHEAD, the mavodelpar two-year safety study.”
The open-label, long-term safety STRIDE AHEAD trial will be conducted outside of the US in PMM patients.
Recently, it was amended to allow enrolment of PMM patients due to both mtDNA and nuclear DNA (nDNA) defects.
Next year, the data from the STRIDE and the long-term safety results from the STRIDE AHEAD trials will be submitted to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in planned marketing applications.
Mavodelpar is currently in clinical development for two rare genetic mitochondrial diseases.