Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced the appointment of senior clinical team leaders, Dr. Mirza Rahman as Senior Vice President, Patient Safety & Pharmacovigilance and Dr. Marcelo Gutierrez, Vice President, Clinical Pharmacology, as well as the expansion of its clinical operations team.
These additions have been made in preparation for the commencement of Cybin’s Phase 3 pivotal trial of CYB003, its proprietary deuterated psilocin program in development for the adjunctive treatment of MDD. Previously, the Company announced the hiring of experienced drug development leaders Dr. Atul R. Mahableshwarkar, and Dr. Tom Macek, as program leads for CYB003 and CYB004, respectively. Together, the team provides significant expertise and decades of experience across critical domains that are integral to the Company’s upcoming pivotal program.
“As we stand ready to commence our Phase 3 pivotal trial of CYB003, we are pleased to welcome these talented and experienced industry leaders to our clinical development team,” said Doug Drysdale, Chief Executive Officer of Cybin. “Dr. Mirza Rahman’s expertise in patient safety and pharmacovigilance, and Dr. Marcelo Gutierrez’s proven track record of delivering clinical pharmacology packages for advancing drugs through the regulatory process, will be instrumental to our efforts. These seasoned industry leaders, as well as the other additions to our clinical operations team, bring a wealth of knowledge and experience around mental health disorders, and will further bolster our internal capabilities, pharmacovigilance, and chemistry, manufacturing and controls management. As we advance to our Phase 3 program, which consists of three studies across 12 different countries, we look forward to benefiting from the guidance and operational experience of Cybin’s newest team members,” concluded Drysdale.
Cybin has strengthened its clinical and R&D team with the recent addition of senior team members:
- Dr. Mirza Rahman, M.D., M.P.H., FACPM, Senior Vice President, Patient Safety & Pharmacovigilance. Dr. Rahman has over 25 years of experience in the pharmaceutical industry, primarily in Pharmacovigilance, but also in Clinical Development, Medical Affairs, Pharmacoeconomics, Manufacturing, and Regulatory Affairs. Previously, Dr. Rahman served in leadership positions at global healthcare companies including Organon and Otsuka Pharmaceuticals, where he played an integral role in leading pharmacovigilance strategy and prioritizing patient safety. Dr. Rahman is board-certified in Public Health & General Preventive Medicine and serves as the President of the American College of Preventive Medicine. In addition, he is an Adjunct Associate Professor at both Columbia University & the University of Guyana.
- Dr. Marcelo Gutierrez, Ph.D., Vice President, Clinical Pharmacology. Dr. Gutierrez has extensive experience leading clinical pharmacology programs across central nervous system (“CNS”) and other therapeutic areas. Dr. Gutierrez previously held leadership positions in the field of Clinical Pharmacology and Global Health at various pharmaceutical companies including Forest Research Institute, Actelion Pharmaceuticals, Novartis, and Amylyx, where he led the creation of several clinical pharmacology centers of excellence and successfully contributed to bringing four drugs through NDA submission and approval.
- Atul R. Mahableshwarkar M.D., DLFAPA, Senior Vice President, Clinical Development. Dr. Mahableshwarkar is leading the CYB003 program, Cybin’s proprietary deuterated psilocybin analog program in development for the adjunctive treatment of MDD. Dr. Mahableshwarkar is a board-certified psychiatrist and accomplished drug development executive with experience in both large global and small startup pharmaceutical companies. 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.
- Dr. Tom Macek, Pharm.D., Ph.D., Senior Vice President, Clinical Development. Dr. Macek is leading the CYB004 program, Cybin’s proprietary deuterated DMT program in development for the treatment of Generalized Anxiety Disorder. Dr. Macek brings decades of pharmaceutical industry experience in new drug development across all phases of research (pre-IND to post-approval) across diverse treatment modalities and has submitted or supported several INDs and NDAs/BLAs leading to drug approvals.
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin program, about to enter Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated DMT program in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.