US-based Escient Pharmaceuticals has unveiled results that could bring a targeted approach for mast cell-medicated diseases closer to fruition.

Data from the Phase I study demonstrated that EP262 was safe and well-tolerated at all dose levels, according to Escient.

The company also stated that no serious adverse events were observed. Treatment-emergent adverse events did not increase with dose and were mild, with an incidence lower than placebo.

The Phase I study was a randomised, double-blind, placebo-controlled trial with 64 healthy volunteers to evaluate the drug candidate’s safety and tolerability. Participants in cohorts of eight were administered five single ascending doses (50mg to 1200mg) and three multiple ascending doses (50mg to 300mg) orally once daily.

Escient has developed EP262 to target G protein-coupled receptor MRGPRX2. When this receptor is activated, mast cells release a range of molecules, including histamines, that can cause hives, angioedema, type 2 inflammation, and chronic pruritus.

By blocking MRGPRX2, the company says its preclinical data shows a potential to treat mast cell-mediated diseases. The company is primarily focusing on chronic urticarias (hives) and atopic dermatitis (eczema).

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By GlobalData

The standard treatment for hives and eczema is antihistamine medication and corticosteroids, respectively. These can cause unpleasant side effects, even when prescribed for a short duration or at a low dose.

Escient chief medical officer Christian Weyer said: “The absence of significant safety findings in this first-in-human study of EP262 is consistent with findings from nonclinical toxicology studies.”

“Having pioneered research on MRGPRX2 pharmacology with our proprietary preclinical knock-in model and successfully completed Phase I, we now look forward to evaluating the therapeutic potential of this new target in patients with mast cell-mediated disorders, a first in the field.”