16 July 2018 - - Newark, New Jersey-based drug design and development company Cellix Biosciences, Inc. has received confirmation from the US FDA that the 505(b) (2) regulatory pathway is appropriate for development of CLX-106 for treatment of relapsing-remitting multiple sclerosis (RRMS), the company said.
CLX-106 is a novel molecular conjugate designed to deliver an optimal therapeutic profile of monomethyl fumarate (MMF) for RRMS. MMF is the active moiety of dimethyl fumarate, an approved RRMS therapy that achieved global sales of over USD 4bn in 2016.
Cellix Bio has engaged Camargo Pharmaceutical Services, LLC for regulatory consulting and strategic development services for CLX-106 in the US.
The company works with the scientific community, universities, and research institutions to advance and build the value of the Synergix platform, develop the most promising intellectual property, and create value for its stakeholders and investors.
Cellix has a robust pipeline of new medicines addressing unmet medical needs across diverse therapeutic areas including neurology, inflammation, and metabolic diseases.