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Lead Pharma to start Phase I Clinical Trials with Psoriasis treatment

Lead Pharma, a pharmaceutical company developing innovative medicines for the treatment of immunological and oncological indications, has achieved a fourth milestone under its license & 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, for the treatment of the autoimmune skin disease psoriasis.

“We are excited to have reached this important milestone in our collaboration with Sanofi. This is Lead Pharma’s first compound to enter the clinic, representing a significant next step in the realization of our growth ambitions”, said Frans van den Berg, Chief Executive Officer of Lead Pharma.

“The progression into clinical development with this project is great validation of our strength in innovative drug discovery, which is also being applied to our internal pipeline projects”, added Arthur Oubrie, Chief Scientific Officer of Lead Pharma.

Steve Pascoe, MD, Head of Immuno-Inflammation Development at Sanofi Genzyme, commented: “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.”

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.