# INTERVIEW: ImmuPharma Will continue to push Lupuzor forward

- Link: https://www.directorstalkinterviews.com/interview-immupharma-will-continue-push-lupuzor-forward/412749478
- Published: 2018-04-18T07:28:17+01:00
- Author: Giles Arbor

**Immupharma Plc** (LON:IMM) Chairman Tim McCarthy talks to DirectorsTalk about 
the topline results of the Lupuzor™ pivotal phase III. Tim provides his perspective
on the data issued to the market, shares his confidence on the overall safety and
efficacy of Lupuzor, talks about next steps regarding partnering, other project 
in the pipeline and the current cash position.

ImmuPharma Plc is a pharmaceutical development company listed since 2006 on AIM 
of the London Stock Exchange (AIM: IMM), focusing on developing novel medicines 
with high sales potential in specialist markets with serious unmet need. ImmuPharma
is led by a commercially focused Board and management team with extensive experience.

**Lupuzor™**

Lupuzor™ (also referred to as Forigerimod, or P140) is ImmuPharma’s lead compound
and a potential treatment for lupus (or Systemic Lupus Erythematosus), a chronic,
potentially life-threatening auto-immune disease. Lupuzor™ has a novel mechanism
of action aimed at modulating the body’s immune system so that it does not attack
healthy cells, and avoids causing adverse side effects. It has the potential to 
halt the progression of the disease in a substantial proportion of patients.

Lupuzor™ has been granted Fast Track status by the US FDA and approval to start 
Phase III under Special Protocol Assessment (SPA) comprising of two phase III trials.
This SPA was subsequently amended due to its strong safety and efficacy profile 
to allow for a reduced number of patients in the pivotal Phase III trial thereby
reducing the projected cost and time of development considerably.

The recently completed pivotal Phase III clinical trial was entitled “A 52-Week,
Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the
Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients
With Systemic Lupus Erythematosus”.

**Commercial Opportunity**

There are an estimated five million people globally suffering from Lupus, with approximately
1.5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America).
Current ‘standard of care’ treatments, including steroids and immunosuppressants,
can potentially have either serious side effects for patients or limited effectiveness,
with over 60% of patients not adequately treated. If Lupuzor™ is approved, it will
be entering a market with the potential for multi-billion dollar sales.

**P140/Forigerimod in other indications**

ImmuPharma together with Professor Sylviane Muller, Lupuzor’s inventor, have presented
new evidence supporting Lupuzor’s™ Forigerimod / P140 peptide activity in several
other major auto-immune disease indications outside of Lupus. In particular, the
peptide appears to have general effects against auto-immune and even chronic inflammatory
indications and pre-clinical evidence supports the molecule’s use in: Neuropsychiatric
lupus (NPSLE); Gougerot-Sjögren Syndrome (GSS); Guillain-Barré Syndrome; Chronic
Inflammatory Demyelinating Polyneuropathy; Arthritis; Crohn’s Disease and Asthma.

**Oncology and Ophthalmology**

ImmuPharma’s second most advanced pipeline programme, IPP-204106, is a potential
treatment for various cancers and acts by modulating angiogenesis and proliferation.
The programme involves the development of synthetic peptides, Nucants, which target
certain nuclear proteins such as nucleolin and nucleophosmin on the surface of cells,
with very high affinity and selectivity. Nucleolin is a protein which controls critical
pathways within the cell. The protein is over-expressed at the surface of dividing
cells which makes its binding with Nucants very attractive because of its potential
selectivity – this is of particular importance in tumour targeting. It has been 
recently demonstrated (published in Cancer Res) that the Nucants improve the vascularisation
of tumours, increasing thereby the cytotoxic drug concentration and consequently
the reduction of tumour size. In connection with the increased vascularization we
investigated its use in age-related macular degeneration where it has demonstrated
positive preclinical efficacy results, diabetic retinopathy and other ophthalmological
indications. Two phase I trials have been completed and IPP-204106 is Phase II ready.

**Metabolism and Diabetes**

ImmuPharma Plc subsidiary ‘Ureka’ has initiated the development of a novel and innovative
peptide technology platform through the collaboration with CNRS, gaining access 
to pioneering research centred on novel peptide drugs at the Institut Européen de
Chimie et Biologie (IECB). Jointly, ImmuPharma and CNRS have filed a new co-owned
patent controlling this breakthrough peptide technology. Ureka’s current focus is
in Diabetes Type II (GLP-1 analogues – once a month administration) and in Non-Alcoholic
Steato-Hepatitis (NASH) where outstanding results have been obtained in validated
pre-clinical experiments with peptide URK 614. There is also potential in cancer
treatment (protein/protein interaction; P53 gene).

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