Phrixus Pharmaceuticals announces SMARTT/NHLBI award of regulatory affairs and initial pharmacology and toxicology services for Carmeseal-MD under development to treat respiratory and cardiac deficits in Duchenne muscular dystrophy
ANN ARBOR, MI – 1 December 2014
Phrixus Pharmaceuticals, Inc., a specialty pharma company based in Ann Arbor, MI, today announced that the company has received an award of regulatory affairs and initial pharmacology and toxicology services for Carmeseal-MD (Poloxamer-188 NF), which is being developed to treat respiratory and cardiac deficits in Duchenne muscular dystrophy (DMD), the most devastating of the muscular dystrophies. Funding for these services is from the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) program: “Science Moving towards Research Translation and Therapy” (SMARTT). Regulatory affairs support will be provided by RTI International, Research Triangle Park, NC, and the pre-clinical studies will be conducted by SRI International, Menlo Park, both under contract with the NHLBI SMARTT program.
Thomas A. Collet, President and CEO of Phrixus commented: “We are delighted to receive this award from NHLBI and to receive their support for our aspiration of making Carmeseal-MD the first therapy for respiratory and cardiac dysfunction in DMD, the two leading causes of mortality in this under-served patient population. The support from SMARTT will allow us to establish a clinical development path for Carmeseal-MD as an easy-to-administer, once-a-day subcutaneous injection similar to long-acting insulin.
SMARTT Program Director, Sonia Skarlatos, PhD, commented: “The mission of SMARTT is to accelerate translation of research from bench to bedside by providing services that support pre-clinical studies and regulatory submissions. We congratulate Phrixus on successfully completing the SMARTT review process, and look forward to assisting with studies that will move the company closer to submission of an investigational new drug FDA.