4D pharma PLC (AIM:DDDD, NASDAQ:LBPS) shared 'highly encouraging' follow-up data from its early-stage asthma trial using its lead live biotherapeutic asset.
The first part of the phase I/II study revealed ‘multiple’ signs that MRx-4DP0004 might help control the condition, supporting its move onto the second stage of the clinical evaluation process.
Crucially, researchers achieved their primary goal of proving the oral medication was safe and well-tolerated.
"The further clinical results announced today are highly encouraging," chief executive Duncan Peyton said.
“Beyond achieving the primary endpoint, we have seen positive trends in multiple secondary endpoints of efficacy that we will be assessing in Part B [of the trial process], including statistical significance at all time points in what will be the primary endpoint in the Part B phase of this trial."
In all, 34 people took part in the early-stage assessment of MRx-4DP0004, 16 of whom took a medicinally inert placebo, with the remainder receiving the active compound.
At end of treatment, just over 80% of patients receiving MRx-4DP0004 experienced reductions in their asthma control questionnaire score, as compared to the placebo group.
The next stage, Part B of the phase I/II trial, will see the recruitment of up to 90 people.
The group generates live biotherapeutic drug candidates from good bacteria strains taken from the human microbiome, which resides mainly in the gut.