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

  • Sanofi, Lead Pharma’s collaborative partner in the development of
    SAR441169, successfully initiated first human dosing with this novel
    RORγt Inverse Agonist candidate treatment
  • For Lead Pharma this represents a fourth payable milestone in the
    SAR441169 collaboration with Sanofi

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.

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About Autoimmune Disorders

A wide range of human diseases are driven by deregulated immune
function. These immune-mediated disorders include joint diseases such as
rheumatoid arthritis and inflammatory bowel diseases such as ulcerative
colitis and Crohn’s disease. Often, these diseases are characterized by
inappropriate activation of molecules termed cytokines, which are
important mediators of normal immune function. When inappropriately
activated, these powerful molecules can cause severe damage to multiple
body systems. Symptoms of immune-mediated diseases range from mild skin
rashes to severe organ failure to death. In addition to the significant
suffering of patients, the socioeconomic burden of just rheumatoid
arthritis has been estimated at approximately $40 billion in the U.S.
alone (cf. J Rheumatol 2011; 88; 55-61; http://www.jrheum.org/content/88/55).

About RORγt

The nuclear receptor retinoic acid receptor-related orphan receptor
gamma, also known as RORγt, is a key regulator of the cytokine immune
pathway, which leads to the differentiation of T cells to a
pro-inflammatory subtype of T helper cells called Th17. RORγt drives the
production of key pro-inflammatory proteins, including interleukin
(IL)-17A, IL-17F and the receptor for IL-23. In the last years, several
clinical studies have validated the critical role of the IL-17 pathway
in chronic autoimmune-related inflammation. Recent findings have
demonstrated that the biological function of RORγt can be moderated with
small molecules and have advanced this target to the cutting edge of
drug discovery.

About Lead Pharma

Lead Pharma is a pharmaceutical company focusing on the discovery and
development of innovative medicines for the treatment of autoimmune
diseases and cancer. Lead Pharma’s drug discovery engine combines
medicinal, structural, and computational chemistry with molecular
pharmacology, cell and tissue-based pharmacology. Lead Pharma has a
pipeline of first- and best-in-class small molecule drugs in various
stages of drug discovery and pre-clinical development.

Lead Pharma is a privately owned company based in Oss, the Netherlands.
Shareholders in the company include BOM Brabant Ventures, Oost NL, Biox
Biosciences and Waterman ventures.

About the license & collaboration agreement

In February 2015, Lead Pharma and Sanofi entered into a license &
research collaboration agreement to discover, develop and commercialize
small molecule therapies directed against RORγt. Lead Pharma is eligible
to receive milestone payments and is entitled to receive royalty
payments on global sales from any resulting products.

For more information visit: www.leadpharma.com

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Media Inquiries:
LifeSpring Life Sciences Communication,
Leon Melens
Tel.: +31 (0) 6 538 16 427


Lead Pharma Holding B.V.
Frans van den Berg MSc
Chief Executive Officer
Tel.: +31 412 782999

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