MedRhythms has announced that the company’s pivotal trial for MR-001, a novel digital intervention being developed to treat gait deficits in chronic stroke, was successfully completed and met its primary endpoint of improvement in gait speed.
The multi-site randomised controlled trial was conducted at eight of the top rehabilitation hospitals and research institutions in the USA, according to a MedRhythms press release. It included adult chronic stroke survivors who participated in 30-minute sessions, three times per week, over a five-week intervention period. The study participants either used MR-001 or were part of an active control group.
MedRhythms intends to submit these “important clinical data” for peer review in a scientific journal, and to present the data at a major conference later this year, the release also notes.
MR-001, which is in development to treat chronic stroke gait deficits, is anticipated to be the first product the company brings to market.
Another advanced pipeline programme being worked on by MedRhythms is MR-004—a novel, investigational prescription digital therapeutic targeting gait deficits in multiple sclerosis, for which the company has entered into a license agreement with Biogen. The company has also initiated feasibility studies of MR-005, which is in development to treat gait deficits in Parkinson’s disease, and MR-010, which is in development to treat gait deficits in post-acute stroke.
“There are at least three-and-a-half million chronic stroke survivors living with gait deficits for which there is currently no standard of care in the USA,” said Brian Harris, CEO and co-founder of MedRhythms. “The topline results from our pivotal trial in chronic stroke suggest that our product can help address this unmet need to improve walking. Successfully completing our pivotal trial with MR-001 is a critical milestone and represents significant progress towards getting this solution into the hands of patients who need it.”