COVID-19 Industry Impact

Mitochondrial-Based Therapeutics – Pipeline Analysis, Clinical Trials and Developments

Mitochondrial-based therapeutics pipeline currently exhibits a burgeoning pipeline with 27 drug candidates.

Mitochondria generate adenosine tri-phosphate (ATP) through oxidative phosphorylation, and also plays a key role in apoptosis. Mitochondrial therapeutic development is focused on diseases, which are caused by mutations in mitochondrial deoxyribonucleic acid (DNA) or in nuclear gene encoding mitochondrial protein.

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Mitochondrial dysfunction contributes to the pathology of many common disorders, such as neurodegeneration, metabolic disease, heart failure, and ischemic-reperfusion injury. Therefore, several strategies are aimed to therapeutically restore mitochondrial function and hence, smaller number of agents have entered in clinical trials for the development of mitochondrial based therapeutics drugs. The report states that positive clinical trial results and technological advancements are the major factors driving the growth of the mitochondrial-based therapeutics pipeline.

It has been observed that regulatory bodies are increasingly granting designations to mitochondrial-based therapeutics drugs, in order to pace up the development process of clinical trials. For instance, Modis Therapeutics Inc.’s drug candidate, MT1621, received Breakthrough Therapy Designation by the USFDA in 2019; Orphan Drug Designation by the USFDA and EMA; and PRIority Medicines (PRIME) designation by EMA in 2018, for the treatment of TK2 deficiency.

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Other than the companies mentioned above, Stealth BioTherapeutics Inc. and CohBar Inc., are also engaged in the development of mitochondrial-based therapeutics.