MMS Holdings (MMS) ? a data-focused CRO ? provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer's disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company's lead development candidate, PRX-P4-003.
Experts at MMS provided regulatory strategy, writing and operations support, including submission publishing, through an exploratory IND and pre-IND submission, with contributions made from a global team on a 24-hour support clock.
"This submission, especially the use of an exploratory IND, shows how MMS is highly supportive of the most efficient ways to get our Sponsors to FDA approvals," said Ben Kaspar, Senior Manager, Regulatory Strategy, MMS. "Our Sponsors are at an advantage when we provide focused and concise support when needed."
Dr. Uma Sharma, Chief Scientific Officer at MMS, added, "Our continued support and partnership with Praxis Bioresearch as they are awarded a fast-track SBIR Grant will lead to innovative therapies for neurological disorders. We're grateful to be able to contribute to the development of life-changing treatments."
With the positive clinical data from the Phase 0 program and funding of the Fast-Track SBIR Grant, Praxis can now advance PRX-P4-003 to early clinical development.
"It has been a pleasure to work with the MMS team through the successful exploratory IND and Pre-IND meeting submission," says Sandeep Patil, PhD, MD, CEO and Co-Founder, Praxis Bioresearch. "We appreciate timely insights from Ben Kasper in addition to the tireless efforts from the broader submission team that remained dedicated and enthusiastic throughout the process in spite of our challenging timelines."
MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years.
Praxis Bioresearch, LLC, is a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders. Praxis's lead development candidate is PRX-P4-003, a novel prodrug stimulant designed to offer the proven clinical activity of currently marketed stimulants while reducing risk of abuse and addiction. For more information visit: www.praxisbioresearch.com.
These press releases may also interest you