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”)28th June 2019 - 11:50 am
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.
- 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
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.
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)
- 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
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”)