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Leukocyte Selective Anti-Inflammatory Drug Fails To Meet Primary Endpoint in Phase 2 Trial
The study did not meet the primary endpoint of improvement in FEV1 as it failed to demonstrate a statistical difference between IPL512,602 and placebo. Some improvements were seen in a number of secondary endpoints but these were not considered to be clinically meaningful. As in the prior studies, the drug was safe and well tolerated.
Ian McBeath, President & CEO of Inflazyme, today said, "This is a disappointing outcome, especially given the strong pre-clinical data and the earlier signs of efficacy seen with the first generation compound. The outcome has not met the Company's expectations and the Company expects that the development of IPL512,602 will be discontinued. We have a cash balance of approximately $31 million and have a pipeline consisting of complement inhibitors and Prodaptin(TM) technologies, recently obtained through the acquisition of Adprotech, and ATH. We will continue to manage our cash resources prudently and review further M&A opportunities."
Details of the Asthma Study
The asthma study was a double blind, placebo controlled trial carried out in the United States in male subjects with mild to moderate persistent asthma. Patients received either 20mg IPL512,602, or placebo, once a day for three months. 169 patients were evaluable at the end of the study. The primary endpoint of improvement in FEV1 demonstrated less than 2% improvement in lung function for drug treated patients compared with placebo. This was not statistically significant. Certain secondary endpoints, including morning peak expiratory flow (PEF), need for rescue medication (albuterol use), asthma exacerbations and airway hyper-reactivity to a chemical challenge, all demonstrated an improvement in asthma symptoms, but did not meet the pre-set product profile criteria. The Company expects that IPL512,602 will not be developed further in asthma.
Further data analysis is on-going and may yield additional insights into the treatment of asthma and the use of anti-inflammatory drugs in this disease. The Company expects to discuss the scope of any further development plans with Aventis in the near future.
Source: Inflazyme Pharmaceuticals Ltd