The anti-IgE immunotherapy, RP01, is designed to induce the immune system to produce antibodies that block Immunoglobulin E (IgE), the key mediator of an allergic response.
The primary endpoint of the study is safety and tolerability of the immunotherapy. A number of immune markers will also be analyzed as part of an efficacy evaluation. RP01 will be administered to each of three dosing groups in a sequential manner. This is to enable evaluation of the safety and tolerability of the first injection before the next, higher dose is administered.
The decision to move RP01 into phase II clinical trials was the result of a successful phase I trial. The phase I trial of RP01 included several groups of healthy volunteers that were given escalating doses. Data showed RP01 was safe and well tolerated. Participants also developed measurable levels of anti-IgE antibodies, an early indication of potential efficacy.
“The results of the phase I trials were very encouraging, particularly the level of anti-IgE achieved in the volunteers together with other markers of potential efficacy. Once replicated in the upcoming trials, RP01, with its novel mechanism of action, could offer benefit to millions of asthma and allergy patients,” noted Marcus Bosson, CEO of Resistentia.