Catalent signs ODT technology development agreement with Cybin

The CDMO's Zydis technology will help the Canadian biotech to develop fast-acting, shorter-duration formulations of its potential therapy for treatment-resistant psychiatric disorders

CYB003 was recently acquired by Cybin through its purchase of Adelia Therapeutics at the end of 2020.

The project is due to start in April 2021 at Catalent's 250,000-sq. ft site in Swindon, UK, which houses the company’s Zydis development and manufacturing operation, and is capable of producing more than one billion ODTs annually.

Initially, the CDMO will conduct feasibility studies for the manufacturing and analytical testing of ODT doses containing varying quantities of CYB003, alongside different excipients.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, making it ideal for consumers with a swallowing disorder, as well as pediatric and geriatric patients.

Delivering CYB003 in such a dose form could have significant benefits, as an ODT would allow pre-gastric delivery and prevent first pass metabolism, potentially improving the pharmacokinetic profile of the drug.

According to Jonathan Arnold, President of Oral and Specialty Delivery at Catalent, pre-gastric absorption is "crucial" for CYB003's efficacy.

“Our focus on reducing the need for health system resources, such as in-clinic therapist time, is an important part of our goal to create scalable, more accessible treatments for mental health disorders," said Doug Drysdale, Cybin’s CEO.