US-based Reneo Pharmaceuticals has plans to institute cost-saving initiatives, including a workforce reduction by 70%, after its lead candidate mavodelpar failed to meet primary and secondary endpoints in the Phase III trial.
The Phase III STRIDE trial (NCT04535609) evaluated mavodelpar in adult patients with primary mitochondrial myopathies (PMM). The drug did not demonstrate a significant change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24, the study’s primary endpoint.
Following the results, Reneo also suspended the open-label extension Phase II/III STRIDE AHEAD trial (NCT05267574). Furthermore, the company terminated all mavodelpar development activities, as per a 14 December press release.
Reneo’s CEO Gregory Flesher noted that the company will publish the generated data once the final analyses are complete as they are “vitally important to the scientific community” despite the negative outcome.
Reneo’s stock tanked following the news and was down by 82.7% at the market close on 14 December, compared to the market close on the previous day.
PMM are a group of disorders that are associated with changes in genetic material, such as depletions, deletions, or mutations. These changes are found within the DNA of mitochondria (mDNA) or with genes outside the mitochondria (nuclear DNA), and they predominantly affect the skeletal muscle. The disease affects about 1 in 5,000 individuals in the US, as per the US National Organization for Rare Disorders.
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Mavodelpar is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. The drug was also evaluated in fatty acid oxidation disorders in a Phase I trial (NCT03833128). Reneo disclosed positive results from the study in July 2022. The trial showed that mavodelpar was safe and well tolerated in 24 patients with PMM.
In January, the drug was granted fast track designation from the US Food and Drug Administration for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the fatty acid oxidation disorders.
With the current restructuring, Reneo joins the growing list of pharmaceutical companies such as Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have chosen to cut employees to pour their resources into clinical programmes.
Another drug being developed to treat PMM includes Stealth BioTherapeutics’s elamipretide. The drug is being evaluated in a Phase III NuPower clinical trial (NCT05162768) in patients with PMM due to nuclear DNA mutations.