Cocoon Biotech, a biotechnology company focused on utilizing its silk protein-based drug delivery technology for the development of formulations to treat osteoarthritis, has entered into service agreements with Camargo Pharmaceutical Services, LLC (Camargo) to provide end-to-end regulatory consulting and strategic development services for Cocoon's pipeline of products initially developed for the treatment of osteoarthritis. The first joint programme will involve biocompatible silk fibroin loaded with a small molecule therapeutic, and will include pre-Investigational New Drug (pre-IND) meeting planning and preparations through to New Drug Application (NDA) submissions.

Camargo is a highly experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1100 FDA meetings and more than 200 FDA, NDA and ANDA approvals.

"We are pleased to be partnering with Camargo, as they will be an important part of the team which will help execute our pre-IND and overall regulatory strategy in an effort to expedite our products into the clinic and ultimately into the hands of physicians who can help the many osteoarthritis patients in need of more effective medicines," stated Ailis Tweed-Kent, managing director., founder and chief executive officer of Cocoon Biotech. "We believe that the vast experience that Camargo has in navigating regulatory agencies worldwide will be very beneficial to Cocoon both in the near-term and in years to come."

"Our goal at Camargo is to guide our clients with the most cost- and time-effective strategy to navigate the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners," said Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services. "Cocoon's vision of enabling healthy, productive lives for patients worldwide by utilizing silk protein technology excites all of us at Camargo."

Cocoon Biotech's platform technology is biocompatible silk fibroin leveraged as a drug delivery material for osteoarthritis and other unmet medical needs. Silk protein has been shown to be biocompatible and biodegradable in humans, and can be formulated to release active small molecule or biologic drugs locally over many months. Our lead program is a silk fibroin hydrogel loaded with a small molecule drug that aims to provide long-term relief of pain and inflammation when injected into the joint of patients living with osteoarthritis. This lead product is targeted to provide significant safety and/or efficacy advantages over existing oral or intra-articularly delivered treatments for osteoarthritis.

Cocoon Biotech was founded in 2013 to bring treatments for arthritis and other debilitating diseases to market. Cocoon Biotech's platform technology is biocompatible silk protein that can be loaded with small molecule or protein therapeutics and injected into joints to provide effective, long-lasting pain relief and potentially delay the progression of disease. This platform will leverage several unique properties of the silk protein fibroin, including biocompatibility, stability, ease of manufacturing, and the ability to form injectable hydrogels containing high drug loads.