The biopharma Cybin Inc. (NYSEAMERICAN:CYBN) has filed a submission of an Investigational New Drug (IND) application with the FDA for its Phase 1/2a first-in-human clinical trial focused on CYB003.
CYB003 is a proprietary psilocybin analog as a proposed treatment of major depressive disorder (MDD) as an adjunct to psychotherapy.
The study would enroll approximately 40 patients, according to a description on ClinicalTrials.gov. The trials would focus on studying the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of CYB003 in patients with MDD.
The proposed study would use the Montgomery-Asberg Depression Rating Scale to gauge improvements in mood and other parameters.
Psilocybin has received a growing amount of interest in recent years. The compound is the focus of more than 50 studies, including Phase 2 studies focused on depressive and post-traumatic stress disorders.
Cybin is also investigating the potential of its deuterated psilocybin analog to treat alcohol use disorder and mental distress in frontline healthcare workers.
“Following the successful completion of our IND-enabling work just last month, we are very excited to have reached this major milestone toward advancing CYB003 into clinical development so quickly. Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD,” said Doug Drysdale, Cybin CEO, in a news release.
The company believes its deuterated CYB003 psilocybin analog may offer less variability in plasma levels, a faster onset of action, a shorter duration of effect and superior tolerability compared to oral psilocybin.
“Through this Phase 1/2a trial, we are primarily looking to demonstrate the improved [pharmacokinetics] and safety profile of CYB003, as well as efficacy. We have designed the trial to allow people to continue to take their antidepressant medication, which will also allow us to assess the effect of CYB003 on people who are treated with an SSRI. At this time, we expect to have a PK and safety data readout by the end of 2022,” Drysdale said.