V ClinBio Inc. has entered into a service agreement with Camargo Pharmaceutical Services. Camargo will provide end-to-end regulatory consulting and strategic development services including pre-Investigational New Drug meeting planning and preparations through New Drug Applications (NDA) submissions for V ClinBio’s two proprietary medications, CLX-106 and CLX-103, for the treatment of relapsing-remitting multiple sclerosis (RRMS) and ulcerative colitis (UC). After receiving data from initial proof-of-concept trials in humans, V ClinBio plans to implement clinical plans for both CLX-106 and CLX-103.

Both CLX-106 and CLX-103 utilize the proprietary Synergix drug delivery platform, which generates novel prodrugs of approved therapies and conjugates them with long chain fatty acids. This approach targets two critical points in a disease more efficiently than can be achieved by co-administration or independent dosing of multiple therapies and allows for development via the US 505(b)(2) regulatory pathway. 

“With our rich pipeline of products, we are excited to partner with Camargo to bring these two promising medical advancements to patients with RRMS and UC respectively,” said Bob Oliver president and chief executive officer of V ClinBio. “The management team at V ClinBio determined that our best path to market with our lead compounds CLX-103 and CLX-106 would be the 505(b)(2) regulatory pathway, and as such, our aim was to collaborate with a leader in the field.”

“Our goal at Camargo is to develop and execute a strategic roadmap for the 505(b)(2) regulatory pathway and drive commercial success for our partners,” said Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services. “We are excited to work with V ClinBio on the regulatory strategy employing innovative technologies with FDA-approved pharmaceuticals that address the unmet needs of patients worldwide.”