4D pharma PLC (AIM:DDDD, NASDAQ:LBPS) said it finished recruitment for the first part of its phase I/II evaluation of MRx-4DP0004 in patients with partly controlled asthma.
In all, 30 people with the condition have been enrolled on the 12-week study with top-line results expected in the second half of this year.
Chief scientific officer, Alex Stevenson, said of the double-blind placebo-controlled trial: “[It] is expected to provide further validation of the favourable safety profile of Live Biotherapeutic products as a novel class of drug across a wide range of indications, including respiratory disease.”
In the same announcement, 4D said it voluntarily ended enrolment in the phase II assessment of MRx-4DP0004 for the treatment of hospitalised patients with Coronavirus (COVID-19) to focus on its core pipeline.
It cited the increase in vaccination rates, declining hospitalisation rates, and progress in the MRx-4DP0004 asthma clinical trial for the decision.
The company is a specialist in the emerging area of the human microbiome (the bacteria that reside mainly in the gut) and has developed Live Biotherapeutics — products that contain live organisms such as human commensal bacteria.
The approach focuses on single strains to assess specific mechanisms of action targeting a defined disease pathway.
Toxicity has always been a major impediment to the success of new drugs.
In developing its Live Biotherapeutics, 4D has isolated bacteria from healthy human donors which are expected to have “highly attractive safety profiles”.