Lead Pharma Announces Start of Phase I Clinical Trials with SAR441169 Candidate Treatment for Psoriasis

OSS, The Netherlands–(BUSINESS WIRE)–Lead Pharma, a pharmaceutical company developing innovative medicines
for the treatment of immunological and oncological indications, today
announced that it 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.

“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.