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ImmuPharma targets regulatory approval as follow-up study confirms “outstanding” safety profile of Lupuzor
Corporate Update - Replacement
7 May 2019
("ImmuPharma" or the "Company")
CORPORATE UPDATE - replacement
The 'Corporate Update' announcement released on 7 May 2019 at 700am under RNS No 1178Y has been replaced. All material details remain unchanged. The Notes to Editors have been added. The full text is shown below.
ImmuPharma PLC (LSE: IMM), the specialist drug discovery and development company provides an update on ongoing activities.
Lupuzor™ is the Company's late stage asset for Lupus, a potential life threatening auto-immune disease. Following the conclusion of the pivotal Phase III trial in 2018, ImmuPharma continues to look at opportunities which the Board believes over the longer term have the potential of bringing Lupuzor™ to market. As part of this strategy, the Company confirms that it continues to engage with potential corporate partners as well as consulting with regulatory advisors on potential pathways to market. Whilst these activities continue the commencement of the Managed Access Program for Lupuzor™ will be postponed until the Company has further clarification on these activities.
Lupuzor™ Extension Study
The Lupuzor™ open label extension study, from the original Phase III trial, with a total of 62 eligible patients recruited throughout the US and Europe, remains on track to report results in Q2 2019.
Merger of Elro Pharma and Ureka
ImmuPharma's subsidiaries Elro Pharma Sarl and Ureka Sarl, both based in France, are focussing on unique technologies: the Nucant cancer programme (Elro) and the peptide platform (Ureka).
As previously announced, the Company has been exploring its options to licence, divest or 'spin-off' the technologies of both of these subsidiaries to unlock their future potential and enhance value to shareholders.
Following an internal review, the Company's intention is to merge these two subsidiaries, in order to create a stronger combined company with a platform technology together with a drug candidate in clinical development, with a view to securing external investment either from private equity or through a public listing on a European stock exchange. This in turn would allow ImmuPharma PLC to focus on Lupuzor™ and the overall P140 platform for different auto-immune indications. Further details will be announced in due course.
Further to the announcement of 1 April 2019, all discussions with Incanthera on the Nucant cancer programme and broader collaboration discussions have now terminated.
ImmuPharma will provide a further update on its operations and strategy in its Final results for the year ended 31 December 2018, which are expected to be announced by the end of this month.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")
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Notes to Editors
About ImmuPharma plc
ImmuPharma (AIM: IMM) is a pharmaceutical development company listed since 2006 on AIM of the London Stock Exchange 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.
The 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". Top line data was announced on 17 March 2018. The data showed that Lupuzor™ demonstrated a superior response rate over placebo (52.5% vs 44.6% "responders") in the primary analysis on the Full Analysis Set of all 202 patients. Importantly the study confirmed the outstanding safety profile of Lupuzor™, with no serious adverse events being reported. However, due to the high response rate in the placebo group, this superior response did not allow statistical significance to be reached (p = 0.2631) and the trial's primary end point was not met. For more information go to: http://www.immupharma.co.uk/top-line-results-lupuzor-pivotal-phase-iii-trial.
ImmuPharma together with Professor Sylviane Muller, Lupuzor's inventor, have presented evidence supporting Lupuzor's™ Forigerimod / P140 peptide activity in several other major auto-immune disease indications outside of Lupus including Rheumatoid Arthritis, Crohn's Disease, and Asthma. In particular, the peptide appears to have general effects against chronic inflammatory indications. Other pre-clinical evidence supports the molecule's use in: Neuropsychiatric lupus (NPSLE); Gougerot-Sjögren syndrome (GSS); and Guillain-Barre disease (chronic/CIDP).
For more information, please visit www.immupharma.co.uk
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