ImmuPharma pleased with Lupuzor open-label study results

Specialist drug discovery and development company ImmuPharma released the analysis of results from the open-label six month extension study from its original pivotal phase 3 trial of ‘Lupuzor’ on Friday.

The AIM-traded firm said the study was part of its lead programme for the potential breakthrough compound for lupus - a potentially life threatening auto-immune disease.

It explained that, following requests from both Investigators and patients involved in the pivotal phase 3 study, it initiated an additional study in January last year, permitting patients who participated in the phase 3 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 3 trial, with the primary endpoint being to evaluate safety and tolerability.

ImmuPharma said the primary objective of the study extension was to evaluate the safety and tolerability of a 200 microgram dose every four weeks for 24 weeks of Lupuzor, in patients with lupus who had participated in the pivotal phase 3 study.

It said the primary endpoint was successfully met, confirming the “outstanding and robust” safety profile of Lupuzor, while also reporting no serious adverse events.

The company said the secondary efficacy objectives of the study extension were to evaluate the effect of Lupuzor in the clinical SLEDAI-2K total score at final visit compared to initial visit, and the remission of the disease.

It said 36% of patients were responders considering a clinical response as a SLEDAI-2K clinical score of nil, or a reduction of at least four points in the SLEDAI-2K clinical score.

Additionally, 32% of patients were in remission considering a clinical response as a SLEDAI-2K clinical score of zero.

“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,” said ImmuPharma’s chief scientific officer Dr Robert Zimmer.

Tim McCarthy, the firm’s chairman, added that the board was “delighted” that Lupuzor had again confirmed its robust safety profile.

“We are confident that Lupuzor has the potential to bring a much-needed treatment to lupus sufferers around the world,” McCarthy said.

“We look forward to providing our shareholders with further updates as and when appropriate.”