Stealth BioTherapeutics (Stealth) is a privately held clinical-stage biopharmaceutical company developing a first-in-class platform of novel therapeutic compounds.
Stealth’s new pipeline candidate for the proposed treatment of mitochondrial dysfunction is expected to move into clinical stage trials by the end of 2019.
Under the terms of the collaboration announced earlier this week, Evotec will be responsible for all preclinical and toxicology/safety studies ahead of the trials.
Mario Polywka, COO of the preclinical contract research organization (CRO) Evotec, said in a press release, “Our INDiGO platform reduces time and cost while consistently producing a quality data package for clinical trial agreements and investigational new drug filings.”
Mark Bamberger, CSO of Stealth stated, “Our team at Stealth evaluated all options to help support the progression of our newest pipeline candidate through IND filing, and we are confident that Evotec, with its INDiGO platform and the team of experts they have assembled, is the best option to ensure the rapid and high-quality advancement of the compound.”
Neither companies provided further comment.
Mitochondrial dysfunction
Elamipretide, a treatment of mitochondrial dysfunction in both genetic mitochondrial diseases but age-related diseases as well, is already in clinical trials by Stealth. The therapy is a Mitochondria-targeting peptide according to an animal study conducted in 2016.
“We believe that our first-in-class mitochondrial medicines offer a novel approach to the treatment of human disease,” said Reenie McCarthy CEO of Stealth in the press release.
Elamipretide received Orphan Drug and Fast Track designation for its potential to treat primary mitochondrial myopathy (PMM), Barth syndrome, and Leber’s hereditary optic neuropathy.
Stealth also is developing the candidate for dry age-related macular degeneration.
According to NIH, Mitochondrial diseases are caused by genetic mutations. Barth Sydrome, for example, is caused by a mutation in the TAZ gene which is located in the mitochondria, and Leber’s is caused by mutations in mitochondrial DNA.
