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ImmuPharma shares jump as chairman upbeat after phase III data review for flagship drug

ImmuPharma chairman Tim McCarthy said: "We continue to believe Lupuzor has the potential to bring a much needed treatment to Lupus sufferers around the world"
researcher filling a vial
There appears to be a US/European split in the clinical data

ImmuPharma PLC (LON:IMM) shares jumped 6.5% higher on Tuesday after its chairman Tim McCarthy said he believes Lupuzor has the potential to offer lupus sufferers a much needed treatment after researchers took a deeper dive into the data generated by its phase III clinical trial of the company's flagship drug candidate.

Top line results from the study issued last month revealed the treatment missed its primary endpoint. It was efficacious, just not at a level that could be described as statistically significant.

However, the outcome was more nuanced than binary and the latest update perhaps underlines the chairman's optimism.

WATCH: ImmuPharma chairman more optimistic on results for its Lupuzor drug

The analysis revealed that, in the European group of lupus sufferers, Lupuzor had a statistically significant 71.1% response rate against a 48.8% rate in the control group, which received a dummy pill plus the standard of care.

Mixed results in the US

It should be noted, and this is important to the analysis, that in the European group 79 patients, or just under 61% of the group, were anti-body positive, which is a biomarker of the disease. 

In the US study group only 40% were was antibody positive where you'd expect 60-70% to be in this category. This may explain why the out-turn for the US could best be described as "mixed".

So, in the American cohort there were 72 patients, of which 28 were antibody positive, split equally between the active and placebo group. Five people were "responders" in the group receiving medication, while in the control group six responded.

The  anti-body positive result in particular "could allow identification of patients that are more likely to respond positively to treatment with Lupuzor", ImmuPharma said.

Disease modifying agent

Chief scientific officer Robert Zimmer added: "Current treatments (monoclonal antibodies, steroids etc) prescribed to Lupus patients are essentially symptomatic treatments acting irrespectively of the antibody status of the patients. 

"The potential efficacy of Lupuzor seems to be correlated with the presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and we hope to confirm that Lupuzor will come to be considered as a disease modifying agent.

"We believe this is in line with what healthcare practitioners are seeking: precision medicines to target therapies, using biomarkers that reference precisely those patients who could benefit from the treatment options available. This should reduce healthcare costs and improve patient outcomes."

Chairman McCarthy said the ImmuPharma treatment had a "compelling product profile", adding that he was "highly encouraged" by the anti-body positive result.

"We continue to believe 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 we move forward with this programme," he went on.

By mid-morning trading, Immupharma shares were ahead 6.5% at 29.4p.

In a note to clients, analysts at ‘house’ broker Northland Capital said: “These findings are a positive for the Company and the potential commercial value of Lupuzor.

“The anti-dsDNA autoantibody is a significant biomarker within the lupus population and indicates a potential target population for Lupuzor.”

-- Adds analysts comment, updates share price --


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