Camargo in Drug Delivery, Regulatory Consulting Deal

Camargo Pharmaceutical Services, a Cincinnatti, Ohio-based provider of drug development services, has entered into a service agreement with Cocoon Biotech, a Boston-based biotechnology company focused on silk protein-based drug delivery technology, to provide end-to-end regulatory consulting and strategic development services for Cocoon’s pipeline of products initially developed for treating osteoarthritis.

Camargo has experience in strategizing drug and combination-device product development and approval using the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Section 505(b)(2)  permits the US Food and Drug Administration to rely, for approval of a new drug application (NDA), on data not developed by the applicant of the NDA, such as published literature or the agency’s finding of safety and/or effectiveness of a previously approved drug product.

The first joint program between Camargo and Cocoon Biotech will involve biocompatible silk fibroin loaded with a small-molecule therapeutic and will include pre-investigational new drug application meeting planning and preparations through to NDA submissions.

Cocoon Biotech’s biocompatible silk fibroin platform technology is based on the concept that silk protein, which has been shown to be biocompatible and biodegradable, can be formulated to release active small-molecule or biologic drugs locally over many months, Cocoon Biotech said. The company’s lead program is a silk fibroin hydrogel loaded with a small-molecule drug for providing long-term pain relief and for alleviating inflammation when injected into the joints of patients with osteoarthritis. This lead product is developed to provide an alternative over existing oral or intra-articularly delivered treatments for osteoarthritis.

Source: Cocoon Biotech

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