Autoimmunity & Inflammation
P140 is the technology platform, invented by Professor Sylviane Muller and licensed to the Company by our longstanding collaboration partner, the Centre National de la Recherche Scientifique (“CNRS”).
The Company has been developing P140 (Lupuzor™) for the treatment of Lupus. P140’s mode of action has been shown to be relevant to many autoimmune and inflammatory conditions in early pre-clinical studies.
*Phase 2/3 adaptive trial becomes a pivotal trial for filing
LUPUZOR™ for Lupus
Lupuzor™, (forigerimod or P140) is preparing to move into an adaptive phase 2/3 International pivotal trial in H2 – 2023.
Targets systemic lupus erythematosus (SLE), an autoimmune disease for which there is currently no cure. Two approved monoclonal antibody treatments have their limitations and are not widely used.
Lupuzor™, has the potential to be a novel first-line drug therapy for the treatment of lupus.
Lupuzor™, binds to heat shock protein 8 (HSPA8), over expressed on autoimmune cells. It has a novel action distinct and upstream from approved drugs .
Lupuzor™, modulates the immune system. Unlike other therapies it is not an immunosuppressant. It “normalizes” what is otherwise a hyperactive immune state.
Lupuzor™, has shown evidence of efficacy, is extremely safe and well tolerated and is convenient (single, monthly, subcutaneous injection).
Systemic lupus erythematous (SLE) is a chronic, life-threatening autoimmune, inflammatory disease with a pattern of flares and remission. It can affect multiple organs such as skin, joints, kidneys, blood cells, heart and lungs.
About 50% of SLE patients develop Lupus nephritis : an inflammation of the kidney that is caused by SLE.
Treatment: Unmet market need due to the lack of safe and effective treatments. Current drugs have serious side-effects and limited effectiveness.
Market: 5 million people globally suffer from Lupus (1.5 million Lupus sufferers in the USA).
>$2bn sales potential
P140 for CIDP
P140 (forigerimod) shows compelling pre-clinical data in Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), a progressive inflammatory condition of the nerves.
P140’s efficacy has been proven in early pre-clinical models of CIDP.
A phase 2/3 adaptive trial protocol is in process. Regulatory approval and orphan drug designation is expected is underway.
P140 offers potential to:
- reduce the frequency of CIDP disease flares
- reduce the need for hospital IV IgG therapy
- Simple autoinjection 1/month by patient at home
- reduce costs for patient and healthcare system
CIDP is neurological autoimmune disease targeting the nerves. Symptoms include: fatigue, areas of numbness, slow reflexes, weakness in arms and legs. It is characterized by a relapsing-remitting or progressive course caused by demyelination of nerves. Similar to but not the same as MS.
Treatment: Currently no effective approved drug on the market. Intravenous (IV) IgG is the only successful treatment. Hospital visits every 4-6 weeks and long IV duration of several hours.
Market: The prevalence of CIDP ranges from 0.7 to 10.3 cases per 100,000. There is a male predominance, with a gender rate ratio ranging from 1.5 to 4. CIDP primarily affects adults, and the incidence rises with advancing age. P140 could be granted ‘Orphan Drug Designation’ and fast track approval.
Sales potential >$750 million annually.
P140 - Other indications
As part of the ongoing research into P140 a number of new indications have been revealed. They all share the same common cause at the mechanistic level of the cell. Pre-clinical studies have now confirmed P140 activity in asthma (acute and chronic), gout and periodontitis. There have been no new significant drug classes addressing these indications for many years.
P140 - Second generation
We have commenced work to develop a pharmacologically improved version of P140, a second generation product that aims to further strengthen the IP position and provide therapies with different improved administration modalities, yet still maintaining P140 as the active moiety.