Mitochondrial Myopathy Clinical Trial teleconference
12/6/2016 teleconference discussion of data from Stealth BioTherapeutics’ Mitochondrial Myopathy clinical trial.
This summer, Stealth BioTherapeutics (Stealth BT) shared preliminary positive data from the MMPOWER study. The study purpose was to evaluate safety and efficacy of elamipretide (previously known as Bendavia) in adults with primary mitochondrial myopathy and genetically confirmed mitochondrial disease.
Mitochondrial myopathy is primarily characterized by muscle weakness, fatigue, and exercise intolerance. Patients with genetically confirmed mitochondrial disorders may also experience multi-system organ involvement and myriad complications related to the body’s inability to adequately generate energy (ATP) at the cellular level. The MMPOWER trial measured changes in the participant’s ability to complete a Six-Minute Walk Rest, a performance-based measure of functional exercise capacity.
This collaborative presentation is hosted by MitoAction, the United Mitochondrial Disease Foundation, the Foundation for Mitochondrial Medicine, with Stealth BT to learn more about the results from the MMPOWER trial, and information about the planned Phase 3 clinical trial. This special presentation educates and informs patients, parents, caregivers, family members, and others involved in the daily lives of adults and children with mitochondrial disease.
Teleconference led by Stealth BT’s CEO, Reenie McCarthy. “As a leader in mitochondrial medicine, we are committed to developing innovative therapies for rare mitochondrial diseases, as well as for common diseases of aging in which impaired mitochondrial function is a final common pathway,” she says.
Teleconference/webinar offered in collaboration by UMDF, MitoAction.
Stealth reports positive results from MMPOWER trial
Mitochondrial disease organizations across the United States and Canada are thrilled with the results.
“Today’s news from the Stealth BioTherapeutics trial represents far more than data — it provides hope for every adult and child with mitochondrial disease,” said Cristy Balcells, RN MSN, Executive Director of MitoAction.
MMPOWER, a Phase 2 trial, evaluated the systemic delivery of elamipretide for the treatment of primary mitochondrial myopathy, or muscle weakness, in patients with a genetically confirmed mitochondrial disease.
“We offer our congratulations to Stealth BioTherapeutics. Twenty years ago, we never thought we would see clinical trials for mitochondrial disease, let alone the encouraging news shared with our community today,” said Charles A. Mohan, Jr., UMDF Executive Director and CEO. “We are anxious to learn more at our symposium in Seattle next week as we continue to build relationships with our science and industry partners that will result in more clinical trials and potential treatments and cures.”
Maureen Latocki, Executive Director of MitoCanada Foundation, added, “Canadians will be very encouraged by the positive results from the MMPOWER trial. We congratulate StealthBT on this achievement and look forward to next steps.”
“It is exciting to see progress and success by Stealth BioTherapeutics in this area of mitochondria-targeted drug therapy,” said Laura Stanley, Executive Director of the Foundation for Mitochondrial Medicine. “Unlocking answers in one area of mitochondrial malfunction can possibly translate into further impact for another area of mitochondrial disease.”
Stealth will present the release notes today at the BIO International Convention in San Francisco, participating in the Mitochondrial Disease Forum, and Mark Bamberger will present during the “Drug Development for Mitochondrial Disease: Examining the Current Landscape and Scientific/Regulatory Gaps” session.
Data from the MMPOWER trial will be officially presented at the United Mitochondrial Disease Foundation (UMDF) symposium on Friday, June 17 at 8:10 a.m. PT.
“We … look forward to presenting positive results from the MMPOWER trial and our ongoing development plans for elamipretide in rare mitochondrial diseases, for which there are currently no FDA-approved treatments,” said Stealth’s Chief Executive Officer Reenie McCarthy.