Stealth BioTherapeutics (USA), a clinical-stage biopharmaceutical company developing a first-in-class platform of novel therapeutic compounds for the treatment of diseases associated with mitochondrial dysfunction, announced that it is advancing a new pipeline candidate into investigational new drug (IND) enabling studies in collaboration with long-term partner Evotec AG (Germany).
Stealth’s nomination of this novel pipeline candidate marks the culmination of a development initiative resulting in a diverse proprietary pipeline of compounds for the treatment of mitochondrial dysfunction arising in the context of both genetic mitochondrial diseases as well as age-related diseases. Stealth’s lead candidate, elamipretide, has received Orphan Drug and Fast Track designation with respect to late stage clinical development efforts in primary mitochondrial myopathy (PMM), Barth syndrome and Leber’s hereditary optic neuropathy (LHON). Stealth is also developing elamipretide for dry age-related macular degeneration, the leading cause of blindness in the elderly.
Stealth expects to advance its new pipeline candidate to clinical stage studies by the end of 2019 utilizing Evotec’s INDiGO platform. INDiGO is a market-leading integrated drug development solution that accelerates early drug candidates into the clinic by reducing time from nomination to IND submission, typically in less than 52 weeks. Under the terms of the collaboration, Evotec will be responsible for all preclinical and toxicology/safety studies ahead of clinical trials in 2019.