Mahableshwarkar will lead the development of the CYB003 program, Cybin’s proprietary deuterated psilocybin analog.
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Dr. Atul Mahableshwarkar has joined Cybin as senior vice president, clinical development, the company said.
Mahableshwarkar will lead the development of the CYB003 program, Cybin’s proprietary deuterated psilocybin analog. Earlier this year, the Food & Drug Administration granted breakthrough-therapy designation to the psychedelic molecule.
“We are delighted to welcome Dr. Mahableshwarkar to the Cybin team at this critical juncture in the company’s progression,” said Amir Inamdar, chief medical officer of Cybin. “As we approach the initiation of our Phase 3 study of CYB003, Dr. Mahableshwarkar’s deep experience of successfully running global Phase 3 programs will be invaluable. His broad expertise across strategic, developmental and regulatory domains will no doubt contribute to accelerating Cybin’s path forward.”
Mahableshwarkar is a board-certified psychiatrist and experienced drug-development executive with experience in both large global and small startup companies, Cybin noted.
“He brings varied experiences from academia and industry as a site principal investigator for industry-sponsored studies and has submitted several INDs and NDAs leading to drug approvals,” the company said in a news release. “With a focus on drug-development strategy and oversight, he has designed and conducted global clinical trials in Alzheimer’s disease, anxiety disorders, bipolar disorder, major depression, Parkinson’s Disease and schizophrenia and led the development program resulting in the approval of a novel antidepressant.”
Mahableshwarkar graduated from the Armed Forces Medical College in India and completed a residency in psychiatry and a fellowship in neuropsychiatry from The Rosalind Franklin University of Health Sciences/The Chicago Medical School, where he was an associate professor and vice chair of the department of psychiatry and behavioral sciences. He also led the mental health services product line at the North Chicago VAMC, where he managed the mental-health care for veterans.
Mahableshwarkar has more than 180 scientific publications, posters and oral presentations to his credit, according to Cybin.
“With the imminent commencement of its Phase 3 study of CYB003, and the initiation of a Phase 2 study of CYB004, the company’s proprietary deuterated dimethyltryptamine program for the treatment of generalized anxiety disorder, this is an exciting time for Cybin,” Mahableshwarkar said in a news release. “I am extremely encouraged by the recently published positive data across the company’s lead pipeline products and believe that my experience overseeing smaller proof-of-principal/concept as well as large, complex, global Phase 3 trials will contribute to Cybin’s success advancing its portfolio of candidates. I share Cybin’s commitment to bringing forward improved therapeutics for patients who suffer with mental health disorders and look forward to contributing to the team’s efforts.”