08:00 Tue 29 May 2018
Immupharma PLC - Update on Pivotal Phase III Trial of Lupuzor
FOR IMMEDIATE RELEASE
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
("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
This new data follows the top-line trial results published on
Highlights of new data analysis
· Further data analysis demonstrated that in the Europe cohort1 (130 patients) Lupuzor™ plus standard of care ("
· 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
· 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
· 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 |
|
|
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 |
|
|
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 |
|
|
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
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
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
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:
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Notes to Editors
ImmuPharma is a pharmaceutical development company listed since 2006 on AIM of the
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,
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:
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
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