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Primary mitochondrial myopathy treatment: REN001 wins FDA orphan drug title

 Last Update: 2020-07-14
 Source: Internet
 Author: User

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Reneo Pharmaceuticals announced today that the U.SFood and Drug AdministrationAdministrationAgency (
FDA) has awarded the company's primary candidate, REN001, the orphan drug for the treatment of primary mitochondrial muscle disease (PMM)The company also announced the positive results of the recently completed REN001 clinical study of PMM patientsREN001 is a selective PPAR agonisant that treats hereditary myopathy, including PMMPMM is a serious disease caused by a mutation in the mitochondrial gene, and muscle function in PMM patients usually decreases, adversely affects daily function, and shortens the patient's lifespanThere are currently no FDA-approved drugs for PMMDr Niall O'Donnell, chief executive of Reneo Pharmaceuticals, said: "The lives of patients with mitochondrial myopathy are affected in many waysReneo completed a 12-week clinical trial (REN001 study) in PMM patients with mitochondrial genetic defects and muscle historyPatients take REN001 once a day orally, and most choose to participate in an additional 36-week open label extension studyThe REN001 study examined the results of walking tests and some symptom questionnaires, and the safety data of the study showed that REN001 was safe and well tolerated in PMM patients

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