UPPSALA, Sweden, April 19 /PRNewswire/ -- 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.
About Resistentia Pharmaceuticals AB
Resistentia Pharmaceuticals is a privately held biopharmaceutical company developing innovative immunotherapies that target allergic asthma and allergic rhinitis as well as inflammatory disorders. In addition to its lead anti-IgE immunotherapeutic, RP01, Resistentia has initiated pre-clinical development of an immunotherapeutic against complement factor C5a for the treatment of rheumatoid arthritis and other autoimmune diseases. Founded in1998, the company has developed an industrial organization with expertise ranging from molecular immunology, pre-clinical and clinical drug development to industrial biopharmaceutical production. Major shareholders are HealthCap, Industrifonden, BankInvest, SR One and InnKap. Further information can be found at www.resistentia.se.
RP01 is a novel immunotherapeutic that stimulates the immune system to produce antibodies against IgE (Immunoglobulin E), the key mediator of allergic reactions. The antibodies intercept and bind to IgE, thereby blocking it from causing allergic reactions. Such a mechanism of action is potentially effective regardless of the trigger, be it pollen, grass, dust mite, foodstuffs or pets. In Phase I trials, RP01 was safe, well tolerated and the healthy volunteers developed significant levels of anti-IgE antibodies. RP01 primarily targets patients with allergic asthma however other future indications could include allergic rhinitis and peanut allergy.
Resistentia Pharmaceuticals AB
CONTACT: Contacts: Resistentia Pharmaceuticals, Marcus Bosson, CEO, Tel:+46-18-65-39-01, firstname.lastname@example.org. Halsin Partners, MikeSinclair, Director, +44-870-747-0880, email@example.com