ImmuPharma PLC (LON:IMM) said it believes there is a “significant opportunity” for its drug Lupuzor, used to treat autoimmune disease lupus, following the release of top-line results from a phase III trial.
The data revealed Lupuzor was more effective than the placebo (52.5% versus 44.6%). But because the response rate for those taking the non-active medication plus the “standard of care” was so high the end-point of the study was not achieved. That 'end-point' was a statistically significant beneficial impact from Lupuzor.
This initial readout was based on 202 patients, including those who withdrew from the trial.
The effectiveness among the 153 that got to the end of the course of treatment was 68.8% (versus 59.2% for the placebo).
Importantly, in patients who had a certain type of lupus biomarker called anti-dsDNA autoantibodies, Lupuzor worked well when compared with the placebo. Added to that, 7.6% of this group went into full remission, while none did in the placebo group.
The safety profile remained good with no adverse effects
Chairman Tim McCarthy said: “Lupuzor has demonstrated, in this study, a superior response rate over placebo and its exceptional safety, giving it, we believe, a compelling product profile.
“Whilst we are disappointed at the high response in the placebo plus standard of care group that resulted in statistical significance not being reached between the two treatment groups, we believe Lupuzor has the potential to bring a much needed safe treatment to the millions of Lupus sufferers around the world.
“We look forward to providing our shareholders with further updates in due course."
Further investigation merited
ImmuPharma said it believes the top line results “provide evidence for the continued investigation into the development and commercialisation of Lupuzor”. It thinks the drug has the potential to offer patients and physicians a much needed effective and safe treatment for lupus.
Following requests from both investigators and patients, ImmuPharma has begun a further study. This will allow all patients who took part in the phase III trial to receive Lupuzor plus the ‘standard of care’ medication for six months in what’s called an open-label scheme.
The results will be gathered independent of the pivotal trial just completed.
The plan is to look at the full dataset before making a decision, but the company said there is demand for a new lupus treatment.
Expressions of interest
It also said there had been “expressions of interest” in the Lupuzor programme and the phase III study.
“ImmuPharma is in ongoing discussions with a number of larger pharmaceutical companies,” it added.
“The results of this study will now be shared with those potential commercial partners. There can be no certainty as to the outcome or timing of these discussions.”
The shares fell 76%.
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