MONROVIA, CA, November 09, 2012 /24-7PressRelease/ -- William Barchuk, Senior Director of Translational Medicine Development at Janssen R&D will be presenting 'A Phase 2a, Randomized, Controlled Study of JNJ-40929837, an LTA4H inhibitor, in Patients with Asthma' at GTC's 2nd Allergy & Respiratory Drug Discovery Conference taking place in San Diego, CA on January 31st - February 1st, 2013.
Leukotriene B4 (LTB4) is a potent chemotactic mediator implicated in asthmatic airway inflammation. JNJ-40929837 is an oral inhibitor of LTA4 hydrolase, which catalyzes LTB4 production. In order to evaluate the efficacy and safety of JNJ-40929837 in patients with mild, steroid-na´ve atopic asthma, Barchuk's team conducted a phase 2a, randomized, double-blind, placebo-controlled, 3-period bronchial allergen challenge crossover study. Patients received 100mg/day JNJ-40929837, 10mg/day montelukast, or placebo each given alone for 7 days separated by a ≥14-day washout period. The primary endpoint was the allergen-induced late asthmatic response (LAR) measured by the maximal percent fall in FEV1 from 3-10 hours post-challenge. Secondary endpoints were allergen-induced early asthmatic response (EAR) measured by the maximal percent fall in FEV1 0-2 hours post-challenge, LAR and EAR by area under the FEV1/time curve, safety, and the relationship between plasma JNJ-40929837 and ex vivo calcium ionophore-stimulated whole blood LTB4 levels. Sputum LTB4 levels were also analyzed.
Fifteen patients completed all three treatment periods. No statistically significant differences were observed in the primary LAR (p=0.630) or secondary LAR and EAR endpoints with JNJ-40929837 compared with placebo; montelukast treatment led to significant improvements over placebo in the primary LAR endpoint (p=0.014) and the secondary LAR and EAR endpoints. JNJ-40929837 administration substantially inhibited LTB4 production in whole blood throughout the study, and demonstrated a significant decrease in sputum LTB4 levels, thus confirming target engagement. The adverse event profile of the three treatments was similar. No serious adverse events or deaths occurred.
Barchuk's group concludes that LTB4 does not play a role in mediating the acute decline of FEV1 in the bronchial allergen challenge model.
William Barchuk, M.D. is Senior Director of Immunology Translational Medicine at Janssen Research and Development of the Janssen Pharmaceutical Companies of Johnson and Johnson. His responsibilities include designing and running clinical trials with investigational agents, including proof-of-concept and mechanistic studies. Dr. Barchuk joined Johnson and Johnson in July 2005. Prior to that, he was a medical director at the Abbott Laboratories' Immunoscience Development Center. He attended medical school at UMDNJ-New Jersey Medical School and did his clinical training in internal medicine and allergy and immunology. He served as a Clinical Associate at the National Cancer Institute prior to entering the pharmaceutical industry.
This conference is also part of the 2nd Novel Immunotherapeutics Summit, which consists of this track and three other tracks:
11th Cytokines & Inflammation
5th Immunotherapeutic & Immunomonitoring
Immunogenicity & Immunotoxicity
Over 100 leading industrial and academic experts will present at this two-day summit. The Novel Immunotherapeutics Summit will offer an in-depth examination of the challenges involved in the dynamic and ever-changing field of drug discovery and development.
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