Update on Pivotal Phase III Trial of Lupuzor

RNS Number : 4395P

Immupharma PLC

29 May 2018

 

FOR IMMEDIATE RELEASE                                                                                                                       29 May 2018

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

ImmuPharma PLC

("ImmuPharma" or the "Company")

Further Analysis from its Pivotal Phase III Trial of Lupuzor™ in Patients with
Systemic Lupus Erythematosus (SLE) Shows Positive Results in the Europe Cohort¹

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to announce further analysis of the results from its pivotal Phase III trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, a potentially life threatening auto-immune disease.

This new data follows the top-line trial results published on 17 April 2018 and which may create new commercial value for Lupuzor™.  As previously announced, across the whole study population, in those patients who had anti-dsDNA autoantibodies, Lupuzor™ demonstrated a superior response rate over placebo (61.5% vs 47.3%, p=0.0967), although these results were not statistically significant.

Highlights of new data analysis

·      Further data analysis demonstrated that in the Europe cohort¹ (130 patients) Lupuzor™ plus standard of care ("Active Group") showed statistically significant reductions (71.1% vs 48.8%, p=0.0218) in disease activity compared to placebo plus standard of care ("Comparator Group") in 79 patients (60.8%) who were anti-dsDNA autoantibody positive ("Antibody Positive").

·      In the US cohort (72 patients) there were 28 patients who were Antibody Positive (40%) with an equal number of 14 patients in both the Active and Comparator Groups. Of these, 5 patients were responders in the Active Group with 6 responders in the Comparator Group (35.7% vs 42.8%). This contrasting result in the US compared to the positive result in the Europe cohort, may be due to a number of differing factors between the two cohorts, which requires further investigation.

·      Scientific literature indicates that approximately 60-70% of patients diagnosed for Lupus are Antibody Positive². These proportions were seen in the Europe cohort (60.8% of patients were Antibody Positive) and could therefore be considered as representative of the overall Lupus population.

·     In those patients who were anti-dsDNA autoantibody negative ("dsDNA negative") there was almost no difference in disease activity reduction between the Active Group and Comparator Group.

·     Anti-dsDNA autoantibodies are a recognised biomarker for Systemic Lupus Erythematosus.

·     This finding indicates that the activity of Lupuzor™ could be correlated with the presence of anti-dsDNA autoantibodies in Lupus patients. ImmuPharma believes that predictive biomarkers, such as anti-dsDNA autoantibodies, could allow identification of patients that are more likely to respond positively to treatment with Lupuzor™.

·     The results can be summarised as follows:

Full Set	Active Group	Comparator Group
N	101	101
Anti-dsDNA antibody positive (N=107, 53%)	52 (51.5%)	55 (54.4%)
Responders in anti-dsDNA antibody positive patients	32 (61.5%)	26 (47.3%)

Europe Cohort	Active Group	Comparator Group
N	65	65
Anti-dsDNA antibody positive (N=79, 60.8%)	38 (58.5%)	41 (63%)
Responders in anti-dsDNA antibody positive patients	27 (71.1%)	20 (48.8%)

US Cohort	Active Group	Comparator Group
N	36	36
Anti-dsDNA antibody positive (N=28, 38.9%)	14 (38.9%)	14 (38.9%)
Responders in anti-dsDNA antibody positive patients	5 (35.7%)	6 (42.8%)

¹ The phase III trial had two regional cohorts per protocol:

                           1) Europe cohort (Czech Republic, France, Germany, Hungary, Poland & Mauritius) 

2) US cohort

Each cohort had patients randomised 1:1 between the Active Group and the Comparator Group.

² Isenberg DA, et al. Ann Rheum Dis 2016; 75:323-331. Mosca M, et al. J Rheumatol 2006; 33(4): 695-697. Gheita TA, et al. Lupus 2018; 27(7):1081-1087.

Next steps

Immupharma will continue to review the Lupuzor™ Phase III pivotal study's full dataset and will provide further updates as information becomes available and as publications are submitted in medical journals and scientific congresses.

ImmuPharma will discuss these findings with its regulatory, scientific and medical experts in order to formulate discussions with the regulatory agencies on next steps.  In parallel, the Company will also continue to progress discussions with potential corporate partners. At present there can be no guarantee that these discussions will result in a positive outcome for the Company but further announcements will be made as appropriate.

Extension study

The Lupuzor™ extension study, which was announced on 18 January 2018, is continuing and at present 44 patients have been recruited.  The study is anticipated to conclude recruitment around the end of June 2018 and report results in 2019.  We believe that this will provide more valuable information on the potential efficacy and safety of Lupuzor™.

Commenting on the results, Dr Robert Zimmer MD, PhD, Chief Scientific Officer said: "We believe these additional results in Antibody Positive patients are of great value.

The data showed that Antibody Positive patients in the Europe cohort responded significantly better when receiving Lupuzor™, compared to those in the Comparator Group.

Current treatments (monoclonal antibodies, steroids etc.,) prescribed to Lupus patients are essentially symptomatic treatments acting irrespectively of the antibody status of the patients. The potential efficacy of Lupuzor™ seems to be correlated with the presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and we hope to confirm that Lupuzor™ will come to be considered as a disease modifying agent.

We believe this is in line with what healthcare practitioners are seeking: precision medicines to target therapies, using biomarkers that reference precisely those patients who could benefit from the treatment options available. This should reduce healthcare costs and improve patient outcomes."

Tim McCarthy, Chairman added: "In this study Lupuzor™ has demonstrated a superior response rate over placebo and confirmed its exceptional safety profile.  We believe this gives Lupuzor™ a compelling product profile. We are highly encouraged by the statistical significance achieved in the Antibody Positive patient group in the Europe cohort. We continue to believe Lupuzor™ has the potential to bring a much needed treatment to Lupus sufferers around the world. We look forward to providing our shareholders with further updates as we move forward with this programme."

For further information please contact: ImmuPharma plc (www.immupharma.co.uk) + 44 (0) 20 7152 4080 Tim McCarthy, Chairman Lisa Baderoon, Head of Investor Relations Twitter: @immupharma + 44 (0) 7721 413496 Northland Capital Partners Limited (NOMAD & Joint Broker) David Hignell, Dugald Carlean, Jamie Spotswood, Corporate Finance Rob Rees, Corporate Broking [phone] Bryan, Garnier & Co. (Joint Broker) Phil Walker, Corporate Finance Dominic Wilson, Sales [phone]

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Notes to Editors

ImmuPharma PLC 

ImmuPharma 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^™ was 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 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 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. We are also investigating its use in age-related macular degeneration where it has demonstrated positive preclinical efficacy results, diabetic retinopathy and other ophthalmological indications.

Metabolism and Diabetes

ImmuPharma's 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 University of Bordeaux and 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); Non-Alcoholic Steato-Hepatitis (NASH) and there is also potential in cancer treatment (protein/protein interaction; P53 gene).

 

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