(Alliance News) - 4D Pharma PLC announced on Monday it has seen positive results from part A of its phase I/II trials for its asthma treatment known as MRx-4DP0004.
The Leeds-based pharmaceutical company said part A of the trial met its primary endpoint and said that the safety profile of its treatment was comparable to the placebo. No serious adverse events related to treatment were reported.
The treatment had previously demonstrated the ability to reduce airway inflammation in a pre-clinical model of severe asthma.
The phase I/II trial was a multi-centre, double-blind, placebo-controlled study in patients with partly controlled asthma taking long-term medication. The primary endpoint of part A was to evaluate the safety and tolerability of the treatment, with secondary endpoints evaluating clinical activity.
It enrolled 34 patients randomized at a one-to-one ratio to receive MRx-4DP0004 or a placebo twice daily for 12 weeks, in addition to their usual maintenance therapy.
4D Pharma said the treatment generated promising signals of clinical activity, which has supported progression into Part B of the study. Part B is expected to enrol up to 90 patients, informed by the clinical signals identified in part A.
Shares in 4D Pharma were down 1.5% at 58.51 pence on Monday in London.
By Heather Rydings; heatherrydings@alliancenews.com
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