The outcome measure of the study confirmed the efficacy as measured by the Acute Urticaria symptom reduction scores and also confirmed its safety parameters and market advantages.
BLUE BELL, PENNSYLVANIA (PRWEB) January 08, 2015
JDP Therapeutics Inc., a privately held specialty pharmaceutical company, is pleased to announce that the Company has successfully completed the initial Phase 3 clinical trial (ETTAU-02) on its lead candidate JDP-205 in patients with acute urticaria associated with an acute allergic reaction. The result of this study has met and/or outperformed every parameter designed for this trial.
The successful completion of the ETTAU-02 trial represents the achievement of a major milestone for the Company. JDP-205 has been tested extensively in several clinical trials to study its pharmacokinetics, tolerability, safety, and efficacy. This initial phase 3 clinical is a multi-sites, randomized, double-blind, parallel-group study designed to evaluate the efficacy, safety and market advantages of JDP-205 in patients with acute urticaria associated with an acute allergic reaction (“Acute Urticaria”). To optimize the study process, the company focused on hospital emergency departments as the enrollment sites.
“We are very pleased with the outcome and the conduct of the ETTAU-02 trial (primary and secondary endpoints). Our collaboration with various clinical sites at hospitals and clinics has been productive, and it provided a valuable experience for our next pivotal phase 3 trial. We are also pleased with our interactions with the FDA and Health Canada on the design of this initial phase 3 clinical trial for JDP-205”, said Dr. Jie Du, President and CEO of the Company. “The outcome measure of the study confirmed the efficacy as measured by the Acute Urticaria symptom reduction scores and also confirmed its safety parameters and market advantages. We look forward to continuously working with the FDA on the next larger phase 3 clinical trial to enable a successful future filing of an NDA.”
JDP-205 is a proprietary injectable product being developed for the treatment of acute allergic reactions for the hospital market. A market QUANT study surveyed 110 physicians, and revealed that 86% of responding doctors had indicated readiness to use JDP-205 in place of the current therapy when the product is approved by the FDA. A second independent market research study with in-depth clinician interviews confirmed the findings.
Acute allergic reaction is a serious condition, potentially life-threatening, and has been growing at concerning rates with very limited selections of medications for treatment. JDP-205 will offer an alternative and superior treatment to the current therapy for the first time in nearly 60 years. JDP-205 is projected to have a significant commercial opportunity with its peak annual sales in the range of ~$300MM.
About JDP Therapeutics Inc.
JDP Therapeutics Inc. is a privately held, clinical phase 3 stage specialty pharmaceutical company focused on developing small molecule therapeutics to treat life threatening diseases with significant unmet medical needs, primarily for use of acute care in the hospital setting.
JDP Therapeutics pursues unfulfilled opportunities in existing molecules from which it develops unique dosage forms, novel formulations, and new indications to achieve full therapeutic and market potential. This approach mitigates risk, shortens the development cycle, leads to a well-defined regulatory pathway, and fully characterizes clinical needs for each product opportunity.
For further information, please email info(at)jdptherapeutics(dot)com
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Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of JDP relating to matters that are not historical fact, including without limitation those regarding the timing or potential outcomes of research or clinical trials, any market that might develop for any of JDP’s product candidates are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of JDP and/or its partners to develop, manufacture and commercialize, JDP’s ability to fund such efforts with or without partners, and other risks.