ImmuPharma looks to end the scourge of lupus

Across the world’s major medical markets, it is estimated five million people suffer from lupus. With no cure currently available, those diagnosed are condemned to a life in which the inflammatory disease attacks multiple organs, such as kidneys, heart and lungs, as well as skin, joints and blood cells. The need for a knockout therapy for lupus is self-evident. Thankfully, ImmuPharma is on the brink of developing just such a therapy, called Lupuzor.

ImmuPharma is a pharmaceutical development company that has been listed on AIM since 2006. Since its founding in Basel, Switzerland, and with its headquarters in London and research centre in France, ImmuPharma has dedicated itself to the development of innovative drugs to treat serious medical conditions.

ImmuPharma has been taking important and successful strides in the development of a treatment for lupus. The company’s major breakthrough has been with its lead compound, Lupuzor, which is progressing through its pivotal phase III study with development partner Simbec-Orion. With an adequate therapy yet to be developed for lupus, ImmuPharma hopes Lupuzor will revolutionise treatment for sufferers of the disease, while also putting the company at the forefront of the fight against the ailment.

In February, ImmuPharma successfully raised £8.4m through a share subscription. Under the leadership of the company’s new Chairman, Tim McCarthy, the management team has positioned ImmuPharma to forge ahead with this pivotal phase III trial, which is currently estimated to provide top line results at the end of 2017. Raising this capital has allowed the company to draw closer to the last chapter. The next phase, therefore, could be one of the most exciting developments and breakthroughs in the biomedical industry for many years.

Phase progression
With lupus being an autoimmune disease, the drug developed by ImmuPharma is geared to modulate patients’ immune systems. This is achieved by modifying the behaviour of a number of the key cells involved in the development of the disease. Other accepted therapies for treating lupus have largely resulted in unwanted side effects, resulting in lower doses being administered and, therefore, inadequate treatment results.

ImmuPharma’s revolutionary Lupuzor therapy stands out from other attempts to treat lupus through a novel mechanism of action. This method is aimed at modulating the immune system of the user, in order to ensure it does not attack healthy cells, without causing unwanted or potentially damaging side effects. This gives it the potential to stop the progression of lupus in a large proportion of patients.

The recent fundraising of the necessary capital to complete the final phase of this trial was preceded by the initial completion of both phase I and phase II studies. The first phase started in 2006, with healthy volunteers showing no demonstrable side effects due to the compound’s extremely strong safety profile. Lupuzor then successfully completed a phase IIa and phase IIb trial in lupus patients.

The phase IIa trial was intended to determine proof of concept – whether or not the drug therapy worked as intended – as well as to determine the dose range and safety. Those who received Lupuzor on three occasions every two weeks showed a significant clinical improvement in their condition, as well as a decrease in their biomarkers, making the trial a success and meeting its primary end points.

Due to Lupuzor’s excellent safety and efficacy profile, the FDA has granted Lupuzor’s phase III trial a Special Protocol Assessment and fast-track designation

The phase IIb clinical trial started dosing of patients in February 2008, in Europe and Latin America, comparing Lupuzor to a placebo in lupus patients. An interim analysis demonstrated the statistically significant superiority of Lupuzor over the placebo, and was performed and reviewed by an independent data monitoring committee, according to ICH guidelines. This analysis was conducted after 125 randomised patients had completed the 12-week treatment period, half of them having also completed the additional 12-week follow-up (week 24).

The primary efficacy measure was a SLEDAI response, defined as a decrease of at least four points in the SLEDAI score, a scale generally accepted by physicians as an assessment of the clinical activity of lupus patients, a lower score representing lower disease activity. The analysis of the data demonstrated that a 200mcg dose of Lupuzor administered every four weeks was statistically significantly superior to the placebo.

Coming to market
On completion of the phase IIb trial, the results were submitted to the relevant authorities, including the US Food and Drug Administration (FDA). Following this, the FDA gave the go-ahead for the pivotal phase III trial, which has now commenced. The study will take place in around 45 sites – 10 in the US and 35 in Europe. The first US patients have commenced dosing, with European sites now opening and patient dosing expected to start soon.

Importantly, due to Lupuzor’s excellent safety and efficacy profile, the FDA has granted Lupuzor’s phase III trial a Special Protocol Assessment and fast-track designation. This is considered in industry to be a ‘gold standard’ endorsement by the FDA, and can be interpreted as comfirming that the FDA strongly supports the quality of the phase IIb Lupuzor data.

Lupuzor could provide a revolutionary new way to treat lupus. If the pivotal phase III trial is approved, the results will be life-changing for lupus sufferers worldwide. This also presents a key commercial opportunity, as it is meeting a largely unmet market need, with GSK’s Benylsta being the only lupus drug currently on the market. As ImmuPharma has commented before: “Lupuzor has the potential to be a game changer in the treatment of lupus, if it delivers clinical success at phase III.”

Being such an important and revolutionary product, Lupuzor, once approved, is expected to generate good financial returns for both ImmuPharma, its directors (who still own over 20 percent of the company) and its investors. It should be viewed as a good investment opportunity, not only for the above reasons, but also for the key fact that ImmuPharma owns 100 percent of the Lupuzor asset. This is a unique position for a small pharmaceutical company, and means interest from new investors and potential licensing partners, as progress continues, is likely to increase, with long-term handsome returns.