Resistentia reports pioneering results from phase I allergy immunotherapy trial

The interim report from Resistentia’s phase I trial with RP01, a novel universal allergy immunotherapy, shows positive results. The therapy was well tolerated and the healthy volunteers developed anti-IgE antibodies, supporting the novel mode of action of the immunotherapy. ”There is a tremendous need for an efficient, long-acting and cost-effective asthma and allergy treatment. The strength of the interim report has encouraged us to step up our development efforts ahead of the upcoming phase II trials,” says Marcus Bosson, CEO of Resistentia Pharmaceuticals. He adds: ”We can see that this immunotherapy produces the desired effect. This is an important milestone in the development process”. RP01 induces the immune system to produce antibodies against Immunoglobulin E (IgE), the key molecule triggering allergic reactions. The antibodies induced by the immunotherapy bind to IgE and block it from starting allergic reactions. The treatment thus has the potential to block allergenic triggers such as grass, pollen or dust mite. The main purpose of the trial was to study the safety and tolerability of the immunotherapy. Interim data indicate no changes in the studied safety parameters. Those participating in the study have not displayed any general adverse effects that can be linked to the treatment. A secondary objective of the study was to establish the pharmacodynamic profile of the immunotherapy. Here as well, interim data displayed positive results with development of anti-IgE antibodies. The phase I clinical trial, which was initiated in March 2006, includes several groups of healthy volunteers that have been given escalating doses of the immunotherapy. Professor Sven-Erik Dahlén, Chairman of Resistentia’s Scientific Advisory Board, concludes: “The mechanism developed in discovery research has now been confirmed in man with no apparent safety concerns. It will be very interesting to follow the continued clinical development in subjects with allergy and asthma”. Preparations for phase II clinical trials in allergic patients continue.