IMMUPHARMA PLC 24 MAY 2019
ImmuPharma PLC
('ImmuPharma' or the 'Company')
FINAL RESULTS ANNOUNCEMENT
for the twelve months ended 31 December 2018
ImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug discovery and development company, is pleased to announce its final results for the twelve months ended 31 December 2018 (the 'Period').
Key Highlights (including post Period review)
· Stable financial performance over the Period
o Cash balance of £4.9 million (31 December 2017: £2.7 million)
o Loss for the period of £7.2 million (31 December 2017: £6.2 million)
o Research and development expenses of £4.7 million (31 December 2017: £5.1 million)
o Basic and diluted loss per share of 5.19p (31 December 2017: 4.75p)
o A successful,£10 million (gross) fundraising completed in January 2018
o Acquired a 15% stake in Incanthera Limited for £2 million
LupuzorTM
· Top line results of the Company's pivotal Phase III trial of LupuzorTM were announced on 17 April 2018- key highlights include:
· 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. 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
· Across the whole study population, in those patients who had anti-dsDNA autoantibodies, LupuzorTM demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967). Although these results were not statistically significant, further data analysis demonstrated that in the Europe cohort (130 patients) LupuzorTM plus standard of care showed statistically significant reductions in disease activity compared to placebo plus standard of care in 79 patients who were anti-dsDNA autoantibody positive (71.1% vs 48.8%, p = 0.0218)
· The study confirmed the outstanding safety profile of LupuzorTM, with no serious adverse events reported
· Follow-on 'extension' open label study
o A total of 62 eligible patients from the original Phase III trial recruited
o The study is anticipated to report results in Q2 2019
· Discussions continue 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™ is postponed, until further clarification on these activities gained
· As announced on 7 May 2019, a renewed focus on developing the P140 platform within different auto-immune indications outside of lupus - following encouraging pre-clinical data
Other program developments
· Within our two further platforms, Elro Pharma (Nucant) and Ureka Sarl (Peptide), ImmuPharma is exploring options to license, divest or 'spin-off' the technologies of both of these subsidiaries to unlock future potential and enhance value to shareholders - as announced on 7 May 2019
· All negotiations with Incanthera Limited on the Nucant cancer programme and broader collaboration discussions have now terminated - as announced on 7 May 2019
· Advisors appointments
o Spark Advisory Partners Limited appointed as Nominated Advisor in December 2018
o Stanford Capital Partners and SI Capital appointed as Join Brokers in September 2018
Commenting on the statement and outlook Tim McCarthy, Chairman, said: 'We are pleased to report our results for 2018 as well as the key highlights for our programs. Following on from the Phase III results, we are focused on progressing LupuzorTM and the P140 autoimmune platform. Our plans to combine and either divest, spin off or license Elro Pharma (Nucant) and Ureka (Peptide Platform) are planned to unlock value for shareholders. We look forward to reporting on these developments in the coming months. We would also like to take this opportunity to thank our shareholders, scientific advisors, corporate collaborators and the CNRS.'This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ('MAR')
For further information please contact:
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ImmuPharma plc
Chairman's Report
The first half of 2018 saw the completion and reporting of results of the Company's pivotal phase III clinical trial for LupuzorTM. Whilst it was disappointing not to have achieved overall statistical significance in the full set of patients, it was promising to see that LupuzorTM plus Standard of Care demonstrated a superior response rate over placebo plus Standard of Care and an even more superior response in patients with positive anti-dsDNA biomarkers which reached statistical significance in the Europe cohort. For the remainder of 2018, our focus for LupuzorTM was on the Open Label Extension study, the planning of a Managed Access Program as well as discussions with potential partners. Further, we were pleased with the successful completion of a £10 million (before expenses) fundraising in January 2018.
Lupuzor™
LupuzorTM, ImmuPharma's lead program for the treatment of lupus completed its Phase III clinical trial in January 2018 which involved patients in the US, Europe and Mauritius.
The Phase III trial was a double-blind, randomised, placebo-controlled trial. The study involved patients being dosed for one year, receiving 0.2mg once per month subcutaneously. 293 patients were screened illustrating the demand from physicians for a new, safe and effective treatment for lupus. Of these, the required 202 patients were successfully recruited and randomised (dosed). Patients participated in the trial in seven countries across 28 sites.
The clinical trial was undertaken primarily by Simbec-Orion, an international clinical research organisation, which specialises in rare and orphan conditions and has previous direct experience in lupus trials.This was a pivotal study designed to demonstrate the safety and efficacy of Lupuzor™ as part of the Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA).
Lupuzor™ Phase III Top Line Results
LupuzorTM 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 and an even more superior response in the 153 patients who completed the study (68.8% vs 59.2%). However, due to the high response rate in the placebo plus Standard of Care group, this superior response did not allow statistical significance to be reached, and the trial's primary end point was not met. Importantly, in patients who were anti-dsDNA autoantibody positive (a recognised biomarker for Systemic Lupus Erythematosus ('SLE'), LupuzorTM plus Standard of Care demonstrated a higher superior response rate over placebo plus Standard of Care (61.5% vs 47.3%). In the European cohort (Europe and Mauritius), the difference was higher (71.1% vs 48.8%) and reached statistical significance (p=0.218). In addition, 7.5% of the patients in the LupuzorTM plus Standard of Care group went into full remission versus none in the placebo plus Standard of Care group. The study confirmed the outstanding safety profile of LupuzorTM, with zero drug-related serious adverse events reported in the LupuzorTM plus Standard of Care group.
It is important to note that when reference is made to placebo, there are no patients who were treated just with placebo, but all were receiving other drug treatments. Based on the protocol and the commonly accepted study design, there were two groups of patients: (1) patients receiving LupuzorTM plus 'Standard of Care' and (2) patients receiving placebo plus 'Standard of Care'. 'Standard of Care' includes treatment with other drugs such as steroids, anti-malarials, methotrexate, etc. The definition of a 'responder' is based on the SLE Responder Index (SRI-4) score, which requires a reduction of at least four points in this score. Therefore, patients who improve by less than four points are counted as non-responders, but also no distinction is made between patients who improve by more than four points, all being equal 'responders'.
Extension Open Label Study
Following requests from both investigators and patients involved in the Phase III trial, ImmuPharma initiated an additional clinical trial permitting patients who participated in the Phase III study, to receive Lupuzor™ plus Standard of Care for six months in an open label study. The results will be gathered as an 'extension' open label study, independent of the pivotal Phase III trial and will provide additional data on the safety and efficacy of LupuzorTM. The study has now been completed with results anticipated in Q2 2019.
ImmuPharma plc
Chairman's Report (continued)
LupuzorTM - Opportunity and Next Steps
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 per cent of patients not adequately treated.
The Company believes Lupuzor™ has the potential to be a novel specific drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in a substantial proportion of patients. Lupuzor™ has a unique mechanism of action that modulates the activity of CD4 T-cells which are involved in the cell-mediated immune response which leads to the lupus disease. Lupuzor™, taken over the long term, as indicated in earlier stage clinical trials, has the potential to prevent the progression of lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.
The Board believes there are still a number of routes to market for Lupuzor™, including potential corporate collaborations. The Company also continues to consult with regulatory advisors on potential pathways to market. The prime objective of any strategy would be to maximise shareholder return.
LupuzorTM is also being prepared for entry into a Managed Access Programme ('MAP') which would also allow lupus patients early access to LupzuorTM. The commencement of the MAP is dependent on the outcome of ongoing activities surrounding discussions with potential partners and regulatory advisors.
Centre National de la Recherché Scientifique (CNRS)
ImmuPharma continues to have important collaboration arrangements with the Centre National de la Recherché Scientifique (CNRS), the French National Council for Scientific Research and the largest basic research organisation in Europe. This is where Lupuzor™ was invented by Prof. Sylviane Muller, Research Director at the CNRS. This successful and longstanding relationship plays an important role in the progress of ImmuPharma's development pipeline.
Pipeline Overview
LupuzorTM / Forigerimod / P140 in autoimmune indications
Lupuzor™, is also known by its chemical name 'Forigerimod' or P140.ImmuPharma in conjunction with the CNRS are exploring opportunities on expanding into other autoimmune indications, as demonstrated by Lupuzor™'s strong efficacy and safety profile and by its mechanism of action.Certain autoimmune indications, outside of lupus, have the potential for Orphan Drug designation. Further assessment continues with the objective of further indications moving into the clinic in due course.
Nucant Program
ImmuPharma's subsidiary Elro SARL ('Elro') holds our cancer Nucant program, IPP-204106, which is focused on combination therapy approaches. ImmuPharma has reviewed different options for progressing this program and is now pursuing a divestment strategy in combination with the Group's Ureka subsidiary. A grant was awarded by the EU to different EU partners (€7 million total with €430k awarded to ImmuPharma) to develop the Nucants in combination with cytotoxic drugs linked to a solid support. The molecule has also shown promising results in ophthalmology (age-related macular degeneration) models.
Peptide Platform
ImmuPharma's subsidiary Ureka SARL ('Ureka') has been developing lead compounds from its novel and patented peptide technology platform UrelixTM. Ureka is based at the Institut Europeen de Chimie et Biologie (IECB) in Bordeaux, France which is under the joint authority of the CNRS, Inserm and the University of Bordeaux.
ImmuPharma plc
Chairman's Report (continued)
Pipeline Overview (continued)
UrelixTM is focusing on oligourea foldamers as a tool to improve the pharmaceutical properties of peptides. One of the first focus areas of Ureka has been GLP-1 analogues for the treatment of Type II diabetes and NASH (Non-Alcoholic-Steato-Hepatitis) as proof of concept for its technology. In February 2019, the peer reviewed scientific research journal 'Nature Communications' published a paper on Ureka's technology.
Further applications of the UrelixTM technology include protein/protein interactions, notably in cancer, and improvement of marketed efficacious peptides allowing additional long lasting patent protection paving the way for a life cycle management franchise. Novel patented technologies are also currently implemented to cover other aspects of the improvement of peptides including potential oral delivery. Peptides have gained so much attention in the last decade that they are now part of the main strategies, along with small molecules and biologics, for developing new medicines.
£10 million Fund Raising
In January 2018, the Company announced the completion of a placing of 6,944,445 new ordinary shares of 10p each at a placing price of 144p raising a total of £10 million before expenses. The Company raised the funds in order to further strengthen the Company's financial position as negotiations continue with potential partners for Lupuzor™ and to support further investment in ImmuPharma's earlier stage portfolio.
Incanthera Limited
In September 2018, the Company signed a Heads of Terms agreement with Incanthera Limited regarding a potential collaboration on the Nucant program. At the same time, ImmuPharma invested £2 million to purchase 363,637 shares at £5.50 per share in Incanthera Limited and received warrants for a further 363,637 shares at £5.50. This investment represents a holding of approximately 15% in Incanthera Limited. In May 2019, the Company announced that discussions with Incanthera Limited regarding a potential collaboration had terminated. ImmuPharma remain supportive of Incanthera Limited and its programs and abilities.
Current Activities and Outlook
As a Board, we continue to be excited by ImmuPharma's future potential. Looking at the Lupuzor™ top line data announced in April 2018, the drugdemonstrated a superior response rate over placebo with an exceptional safety profile, giving it, we believe, a compelling product profile. We believe Lupuzor™ has the potential to bring a much needed safe treatment to the millions of lupus sufferers around the world. We continue to engage with potential partners and, although no guarantees of a successful outcome can be given at present, we are focused on moving forward with the development and commercialisation of Lupuzor™.
The Company has been exploring its options to license, divest or 'spin-off' the technologies of both Elro and Ureka to unlock their future potential and enhance value to shareholders. 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 or licensing. This, in turn, would allow ImmuPharma to focus on LupuzorTM and the overall P140 platform for different autoimmune indications. We look forward to providing our shareholders with further updates in due course.
The Board would like to thank its shareholders, both long standing and new for their support as well as its staff, scientific and corporate collaborators including the CNRS, Simbec-Orion and CAP Research.
Tim McCarthy
Non-Executive Chairman
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Immupharma plc published this content on 24 May 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 24 May 2019 06:37:09 UTC
