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V ClinBio and Camargo Team to Develop Prodrug Technology Platform.

M2 PHARMA-March 8, 2018-V ClinBio and Camargo Team to Develop Prodrug Technology Platform


- Cincinnati, Ohio-based biopharmaceutical company V ClinBio Inc. has entered into service agreements with Camargo Pharmaceutical Services, LLC, the company said.

Camargo will provide end-to-end regulatory consulting and strategic development services including pre-investigational new drug (pre-IND) meeting planning and preparations through new drug applications submissions, for V ClinBio's two (2) proprietary medications, CLX-106 and CLX-103, for the treatment of relapsing-remitting multiple sclerosis and ulcerative colitis, respectively.

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.

Camargo is a highly experienced global strategist specializing in drug and fixed-dose combination product development and approval utilizing the regulatory pathway provided for in Section 505(b) (2) of the US Federal Food, Drug, and Cosmetic Act.

CLX-106, a patented novel formulation of MMF conjugated to icosapentaenoic acid for the treatment of RRMS and psoriasis, has demonstrated a highly differentiated profile compared with other MMF prodrugs in development.

CLX-103 is a novel, patented prodrug molecular conjugate of mesalamine, eicosapentaenoic acid and caprylic acid designed to offer incremental benefits over the currently approved 5-ASA formulations for the treatment of ulcerative colitis.

V ClinBio, focused on transforming existing compounds into differentiated new therapeutics, is driving the development of novel drug products for treatment of immune and other related diseases.

It develops new molecular entities (NMEs) using incremental innovation and prodrug technology targeted to provide better pharmacokinetic, pharmacodynamics, physicochemical properties, and to enable the development of known agents for both existing and new indications.

Camargo provide comprehensive drug development services specialized for the 505(b) (2) approval pathway and global equivalent processes.

By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, the company builds and executes robust development plans. The company works with product developers across more than 25 countries.

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Publication:M2 Pharma
Date:Mar 8, 2018
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