Skye Bioscience Inc (OTCQB:SKYE), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, said it has selected NextPharma as its contract manufacturing organization (CMO) for its phase 2 clinical trial material.
NextPharma is a European pharmaceutical contract development and manufacturing organization that supplies products globally from its nine sites.
It provides services that range from pharmaceutical development, clinical supplies, scale-up and process validation to commercial manufacturing for a large range of dosage forms, Skye said, noting that NextPharma’s expertise enables it to provide a unique service in certain specialized areas such as ophthalmics.
“Skye completed an extensive search and due diligence process to choose an ideal CMO to produce SBI-100 Ophthalmic Emulsion for its next stages of development and we are pleased that NextPharma has partnered with us on this project,” Punit Dhillon, CEO and chair of Skye said in a statement.
READ: Skye Bioscience reports slight delay in the production of its Phase 1 drug to treat glaucoma
“Apart from their broad expertise in manufacturing commercially-approved drugs for major pharmaceutical clients, NextPharma is also experienced in handling controlled substances, which will be valuable in serving Skye’s needs.
"During our pre-Investigational New Drug (IND) meeting with the FDA’s Division of Ophthalmology, we confirmed that our nonclinical safety package would be sufficient to support a phase 2 study under our first US IND," Dhillon added.
He said Skye plans to file its IND for a US phase 2 clinical study in the fourth quarter of this year and that it expects to start the study in the first half of 2023 and report final data by year-end 2023.
NextPharma CEO Peter Burema said the company manufactures a broad range of ophthalmic drugs at its Tampere site in Finland and that it is "well prepared to implement the production process to meet Skye’s requirements for its innovative new drug candidate”.
Skye Bioscience is a pharmaceutical company unlocking the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with significant unmet needs. The company’s lead program, SBI-100 OE, is focused on developing a treatment for glaucoma, the world’s leading cause of irreversible blindness.
Contact the author at jon.hopkins@proactiveinvestors.com