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Resistentia Initiates Phase II Clinical Testing of Novel Immunotherapeutic for Allergic Asthma |
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20 Apr 2007 |
Resistentia Pharmaceuticals AB, a biopharmaceutical company developing immunotherapeutic products for allergic asthma and inflammatory disorders, announced today the start of a Phase II clinical trial to evaluate safety and efficacy of a novel anti-IgE immunotherapy, RP01, in allergic individuals.
UPPSALA, Sweden | Apr 19, 2007 | Resistentia Pharmaceuticals AB, a biopharmaceutical company developing immunotherapeutic products for allergic asthma and inflammatory disorders, announced today the start of a Phase II clinical trial to evaluate safety and efficacy of a novel anti-IgE immunotherapy, RP01, in allergic individuals. RP01 is designed to induce the immune system to produce antibodies that block Immunoglobulin E (IgE), the key mediator of an allergic response.
The randomized, double-blind, placebo-controlled, multi-center, dose-escalation study, is being conducted in New Zealand. The primary endpoint is safety and tolerability of the immunotherapy. A number of immune markers will also be analysed 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 initial injection will be followed by three booster injections at the same dose. The study will last 52 weeks (with an interim analysis at week 20) and include 42 patients with an allergy towards at least one aero allergen
“The start of this trial is a significant milestone, not only in the development of RP01 but also for Resistentia as it is our lead therapeutic and first to enter Phase II,” noted Marcus Bosson, CEO of Resistentia. “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. We look forward to assessing interim data from the study before the end of 2007.”
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. These data supported the decision to move RP01 into Phase II clinical trials.
SOURCE: Resistentia Pharmaceuticals AB |
