NEWARK, N.J.--(BUSINESS WIRE)--Cellix Biosciences Inc. (“Cellix Bio”), a development-stage pharmaceutical company, today announced confirmation from the U.S. Food and Drug Administration (FDA) that the 505(b)(2) regulatory pathway is appropriate for development of CLX-106 for treatment of relapsing-remitting multiple sclerosis (RRMS). 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 (DMF), an approved RRMS therapy that achieved global sales of over $4 billion in 2016. A pre-clinical safety study and a clinical pharmacokinetic (PK) study will be conducted as expected; future clinical studies will be designed as suggested by the FDA in a recent pre-Investigational New Drug (pre-IND) meeting. Cellix Bio has engaged Camargo Pharmaceutical Services, LLC (“Camargo”) for regulatory consulting and strategic development services for CLX-106 in the United States.
Mahesh Kandula, CEO of Cellix Bio, stated, “We are excited with the responses we have received on our development plan from the FDA. With the FDA’s confirmation that the 505(b)(2) pathway is acceptable for CLX-106, we expect to have relatively lower drug development costs and a faster path to approval.”
Camargo is the global development and commercialization partner with a proven ability to help bring life-changing therapies to the market faster and more cost-effectively. “Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ruth Stevens, Chief Scientific Officer and Executive Vice President, Camargo Pharmaceutical Services. “We look forward to continuing work with Cellix Bio to advance its treatment for RRMS to benefit patients in need worldwide.”
About Cellix Biosciences
Cellix Bio is an innovative biopharmaceutical company founded by Mahesh Kandula, CEO and innovator of SynergixTM technology, and Subbu Apparsundaram, CDO & COO. Cellix Bio is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact with value driven clinical outcomes. Cellix Bio works closely with the scientific community, universities and research institutions to advance and build the value of SynergixTM technology, develop the most promising intellectual property, and create value for its stakeholders and investors. Cellix Bio has a robust pipeline of new medicines addressing unmet medical needs across diverse therapeutic areas including neurology, inflammation and metabolic diseases. For more information on Cellix Bio, visit http://www.cellixbio.com.
About Camargo Pharmaceutical Services
Camargo offers a full portfolio of pharmaceutical services from concept through commercialization to improve medicines. Founded in 2003, Camargo has emerged as one of the recognized experts and industry leaders utilizing the FDA 505(b)(2) approval pathway. The company is passionate about the client’s success and the differences we can make in the lives of others. Camargo’s global reach and client base extends to more than 25 countries. Camargo is headquartered in Cincinnati, Ohio. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com.