Immupharma Regulatory News (IMM)

28 June 2019

ImmuPharma PLC

("ImmuPharma" or the "Company")

Primary endpoint successfully met from the open label extension study evaluating safety and tolerability from the Pivotal Phase III trial of Lupuzor™ in patients with

Systemic Lupus Erythematosus ("Lupus")

Study demonstrates robust safety profile of Lupuzor™ with no 'serious adverse events' reported

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

Key highlights:

· 62 eligible patients enrolled throughout the US and Europe completing a 24 week treatment period

· Primary endpoint successfully achieved confirming the safety profile of Lupuzor™

· No 'serious adverse events' related to Lupuzor™ reported

· As the study is an open label study, only descriptive efficacy data will be produced

Background

Following requests from both Investigators and patients involved in the Pivotal Phase III study, ImmuPharma initiated an additional study in January 2018, permitting patients who participated in the Phase III study, to receive Lupuzor™ (plus "Standard of Care") for six months in an open label scheme. Results were gathered as an "extension" open label study, independent of the Pivotal Phase III trial, with the primary endpoint being to evaluate safety and tolerability.

Study Objectives

Primary Objective: The primary objective of the study extension was to evaluate the safety and tolerability of a 200 microgram ("mcg") dose every 4 weeks for 24 weeks of Lupuzor™ in patients with Lupus who had participated in the Pivotal Phase III study.

Outcome: The primary endpoint was successfully met, confirming the outstanding and robust safety profile of Lupuzor™ whilst also reporting no serious adverse events.

Secondary Objectives: The secondary efficacy objectives of the study extension were to evaluate the following:

· The effect of Lupuzor™ in the Clinical SLEDAI-2K total score at final visit compared to initial visit

· Remission of the disease (i.e. : reduction of clinical SLEDAI-2K score to 0) 

Outcome:

· 36% of patients were responders considering a clinical response as a SLEDAI-2K Clinical score of 0 or a reduction of at least 4 points in the SLEDAI-2K clinical score.

· 32% of patients were in remission considering a clinical response as a SLEDAI-2K Clinical score of 0

*A clinical SLEDAI-2K is defined as SLEDAI-2K score excluding anti-dsDNA and complement (blood analysis) input.

Further announcements will be made as appropriate.

Commenting on the results, Dr Robert Zimmer MD, PhD, Chief Scientific Officer said: "With the positive outcome of this open label extension study with Lupuzor™ having met its primary endpoint and confirming the robust safety profile of the drug, we continue in our discussions with our regulatory experts and potential partners with the key focus of moving Lupuzor™ forward."

Tim McCarthy, Chairman added: ""We are delighted that Lupuzor™ has again confirmed its robust safety profile and we are confident that 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 and when appropriate."

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

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.

About 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™ Phase III Trial

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.

DEFINITIONS

Open Label Study

An open-label trial, or open trial, is a type of clinical trial in which both the researchers and participants know which treatment is being administered. In this case, Lupuzor™.

Standard of Care

"Standard of Care" includes treatment with other drugs such as steroids, anti-malarials, methotrexate etc.

SLEDAI-2K Clinical Score

Systemic Lupus Erythematosus Disease Activity Index 2000

Anti- dsDNA Autoantibodies

Anti-dsDNA autoantibodies is a recognised biomarker for Systemic Lupus Erythematosus (Lupus)

Serious Adverse Event

A serious adverse event is an adverse event occurring at any dose that results in any of the following outcomes or actions: • death • a life-threatening adverse event (ie, the patient was at immediate risk of death from the event as it occurred); does not include an event that, had it occurred in a more severe form, might have caused death • inpatient hospitalization or prolongation of existing hospitalization • a persistent or significant disability/incapacity (refers to a substantial disruption of one's ability to conduct normal life functions) • a congenital anomaly/birth defect • an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the patient and may require medical intervention to prevent 1 of the outcomes listed in this definition

For more information, please visit www.immupharma.co.uk