4D pharma has started with a multicentre Phase I/II double-blind, placebo-controlled study of MRx-4DP0004 in patients with poorly controlled asthma.
The company said Monday in a press release that the study will enrol 90 asthma patients not adequately controlled on their current inhaler maintenance therapy. According to the statement, the patients will take MRx-4DP0004 in addition to existing maintenance therapy. This is the world’s first clinical study of a Live Biotherapeutic in patients with poorly controlled asthma, the company said. It also noted that the results are expectedin 2020.
Alex Stevenson, 4D’s Chief Scientific Officer, said this study opens the full potential of the gut microbiome and Live Biotherapeutics or ‘LBPs’ to treat diseases beyond the gastrointestinal tract. “This year, we have expanded our clinical pipeline to evaluate LBPs in diseases anatomically distant from the gut, firstly in oncology, and now in asthma,” Stevenson noted.
He said that despite available therapies, many asthma patients struggle to achieve control of their disease and suffer from exacerbations often requiring hospitalisation. The results from this study will be an important proof-of-concept in the development of live biotherapeutics as a next generation therapy in asthma management, he concluded.