Stealth BioTherapeutics Inc. (NASDAQ: MITO) stock plunged by 3.57% at last close whereas the MITO stock price gains by 6.17% in the after-hour trading session. Stealth BioTherapeutics is a clinical-stage biotechnology firm dedicated to the research, development, and marketing of innovative medicines for mitochondrial illnesses. Mitochondria are the body’s principal source of energy generation and are essential for appropriate organ function.
MITO stock’ Recent Development
On Dec 20, 2021 Stealth BioTherapeutics provided information on its Duchenne muscular dystrophy (DMD) research programme following a pre-IND meeting with the FDA’s Division of Cardiology and Nephrology (DCN). It also entails reaching agreement on Stealth’s proposal to use myocardial fibrosis progression as a surrogate endpoint in a clinical study.
The pre-investigational new drug (IND) meeting was held to examine Stealth’s projected DMD development strategy. DCN agreed that cardiac fibrosis measured with late gadolinium enhancement (LGE) on magnetic resonance imaging (MRI) may be used as a main endpoint in Stealth’s planned new clinical study. DCN also described the processes that would be required for an Accelerated Approval based on this outcome if it is determined that slowing fibrosis progression is reasonably expected to result in therapeutic benefit in DMD.
DCN said that the clinical study design was in line with various critical features, while urging that further information be presented with Stealth’s anticipated IND on others. Stealth intends to meet with DCN again early next year as it progresses toward submitting an IND in the first part of the year and perhaps starting a study in the second half of the year, depending on regulatory comments and funding.
New preclinical evidence from Stealth has shown that combining elamipretide with an exon-skipping phosphorodiamidate morpholino oligomer (PMO) dramatically enhances dystrophin expression levels in the X-linked muscular dystrophy (mdx) mouse model. PMO is a medicinal class that has previously been approved by the FDA and commercialised for its effects on skeletal muscle.