Health and Healthcare

Is Stealth Bio Done After Mitochondrial Myopathy Study?

Chris Lange

Published: December 20, 2019 10:40 am

Last Updated: December 23, 2019 4:57 pm

Stealth BioTherapeutics Corp. (NASDAQ: MITO) shares were absolutely crushed on Friday after the firm announced results from its late-stage study in patients with primary mitochondrial myopathy. Specifically, the top-line results come from the Phase 3 MMPower-3 trial evaluating elamipretide.

Unfortunately, the study did not meet its primary endpoints assessing changes in the six-minute walk test and Primary Mitochondrial Myopathy Symptom Assessment Total Fatigue Score.

Safety results demonstrated that treatment with elamipretide was well tolerated, with most adverse events mild to moderate in severity.

Looking ahead, Stealth Bio said that it plans to review its operational resources to align them with its near-term priorities of progressing its Barth, AMD and pipeline programs. The company expects to provide further guidance next month.

CEO Reenie McCarthy commented:

We are deeply grateful to our patients and families, our investigators and their teams, and our advocacy partners for their support of this study, and share their disappointment that it did not meet the promise of our earlier trials in this indication. We remain confident in the promise of our platform and committed to our mission of improving the lives of people living with diseases involving mitochondrial dysfunction. We plan to meet with the FDA in early 2020 regarding our Barth syndrome program, where we have observed significant improvement in cardiac stroke volume during open-label extension, and continue to enroll our Phase 2b clinical trial in geographic atrophy associated with dry age-related macular degeneration, in which we observed improvement in visual function during an earlier Phase 1 study. We are also progressing our pipeline of second-generation mitochondrial therapeutics, with lead pipeline compound SBT-272 entering Phase 1.

Shares of Stealth Bio were last seen down about 65% at $4.84, in a 52-week range of $4.26 to $20.99. The consensus price target is $23.17.