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™ (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”.
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).