Phase I trials for psoriasis candidate treatment begin

Pharma, biosimilars in the medicines supply chain

Lead Pharma, a pharmaceutical company developing innovative medicines for the treatment of immunological and oncological indications, has achieved a fourth milestone under its license and collaboration agreement with Sanofi, triggering an undisclosed milestone payment.

The milestone payment is linked to Sanofi’s dosing of the first human volunteers in a Phase I clinical trial of SAR441169, a novel inverse agonist of the nuclear hormone receptor RORγt.

This Phase I study by Sanofi will assess the tolerability, safety, and pharmacokinetics of single and ascending once daily oral dosing of SAR441169 in healthy adult subjects, and is aimed at gaining early evidence on effectiveness after four weeks of oral treatment in patients with moderate to severe psoriasis.

Frans van den Berg, Chief Executive Officer of Lead Pharma, said: “We are excited to have reached this important milestone in our collaboration with Sanofi.”

Dr Steve Pascoe, Head of Immuno-Inflammation Development at Sanofi Genzyme, said: “With the initiation of clinical investigations in humans, this promising RORγt inverse agonist moves one step closer to advancing psoriasis treatment. This is not only exciting for psoriasis sufferers, but could also hold hope for others since this candidate compound works on the interleukin-17 inflammatory pathway, known to be critical in the treatment of a range of chronic autoimmune diseases.”