MetrioPharm is set to advance its psoriasis asset into phase 2b after bringing the drug through an early test of its safety and potential efficacy. Top-line data from the phase 2a suggest MP1032 is safe and hint at its potential to lessen the severity of psoriasis symptoms.
Zurich, Switzerland-based MetrioPharm tested oral macrophage modulator MP1032 in 44 patients with moderate to severe psoriasis. Half of the subjects were randomized to receive MP1032, while the rest were given twice-daily doses of placebo. Investigators at four sites in Germany gave subjects these regimens for six weeks, after which they kept tabs on the patients for a further four weeks.
MetrioPharm was primarily looking for evidence its drug is safe enough to move into a larger trial. On this count, the study delivered for the Swiss-German biotech. Investigators saw the same set of moderate to mild adverse events—common cold, headache and itching—across both arms of the study. And with the study being free from serious adverse events, effects on blood-count parameters and tolerability-related dropouts from the MP1032 cohort, a key part of MetrioPharm’s vision for the positioning of the asset remains viable.
“From a clinical point of view, an oral drug with a better tolerability profile than currently available drugs, is desirable,” Wolfgang Vanscheidt, M.D., one of the study's principal investigators, said in a statement. “I am looking forward to seeing how MP1032 performs in upcoming clinical trials.”
The upcoming clinical trial referred to by Vanscheidt is three-month phase 2b that will give higher doses of MP1032 in a bid to build on the hint of efficacy seen in the phase 2a.
In making its case for the efficacy of MP1032, MetrioPharm focused in on the 16 patients from the treatment arm whose exposure levels to the drug topped 120 ng*hr/ml. Among these subjects, scores on the PASI scale of psoriasis severity fell by a median of 25% from baseline, compared to a 12% drop in the placebo arm. In the four weeks after stopping treatment, the PASI scores of the treatment group moved back toward baseline levels while the those of the placebo arm, “remained relatively unchanged.”
With MP1032 showing the clearest sign of efficacy in subjects whose exposure levels topped a certain level and the safety data coming in clean, MetrioPharm has decided to increase the dose above the twice daily administrations of 100 mg used in the phase 2a.
The data from the phase 2b will go some way to validating the approach taken by MetrioPharm. MP1032 is the lead candidate from a platform MetrioPharm thinks can improve outcomes in immune-mediated inflammatory diseases by targeting shared areas of their pathways. As such, while MetrioPharm is initially assessing the effect of MP1032’s modulation of the H2O2-mediated activation state of macrophages and downregulation of the M1 state in psoriasis, it thinks the oral asset could also treat patients with conditions including tendinopathy and arthrosis.