Cybin Bolsters Clinical Team as CYB003 Phase 3 Trial Nears
Key Insights
Cybin (search) has expanded its clinical team to support the upcoming Phase 3 trial of CYB003 for Major Depressive Disorder (search) (MDD).
Key appointments include Dr. Mirza Rahman as SVP, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as VP, Clinical Pharmacology.
The strengthened team will support pivotal trials across 12 countries, enhancing internal capabilities and pharmacovigilance.
Cybin (search) Inc. (NYSE American:CYBN) (Cboe CA:CYBN) has announced the expansion of its clinical team to support the imminent Phase 3 pivotal program for CYB003, a deuterated psilocin analog, in the adjunctive treatment of Major Depressive Disorder (search) (MDD). The company has appointed Dr. Mirza Rahman as Senior Vice President, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as Vice President, Clinical Pharmacology, alongside other additions to the clinical operations team.
This strategic expansion aims to bolster Cybin (search)'s capabilities as it prepares to initiate a global Phase 3 trial for CYB003, involving three studies across up to 12 countries. The trial will assess the efficacy and safety of CYB003 as an adjunctive treatment to standard antidepressant therapy in patients with MDD.
New Leadership Appointments
Dr. Mirza Rahman brings over 25 years of pharmaceutical industry experience, with a focus on pharmacovigilance, clinical development, and patient safety. His previous leadership roles at Organon and Otsuka Pharmaceuticals underscore his expertise in guiding pharmacovigilance strategies and prioritizing patient safety.
Dr. Marcelo Gutierrez has extensive experience leading clinical pharmacology programs within the central nervous system (CNS) and other therapeutic areas. His prior positions at Forest Research Institute, Actelion Pharmaceuticals, Novartis, and Amylyx involved establishing clinical pharmacology centers of excellence and contributing to multiple NDA submissions and approvals.
CYB003 Clinical Program
CYB003 is Cybin (search)'s proprietary deuterated psilocin analog, designed to offer potential advantages over traditional psilocybin, including optimized pharmacokinetic properties. The Phase 3 program is designed to evaluate CYB003's effectiveness in conjunction with standard antidepressant medications for individuals suffering from MDD.
Doug Drysdale, CEO of Cybin (search), stated, "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. Their expertise will be instrumental to our efforts."
About Cybin
Cybin (search) is a neuropsychiatry company focused on developing innovative treatment options for mental health conditions. Their pipeline includes CYB004, a deuterated DMT program in Phase 2 development for generalized anxiety disorder (search), and a research pipeline of 5-HT receptor-focused compounds.