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In this study, the efficacy of multiple doses of 600mg of MEM 1414 on the allergen-induced asthmatic response in steroid free subjects with mild allergic asthma will be evaluated in comparison to placebo.
The Phase IIa trial will enroll approximately 16 subjects, who will be randomized to receive either 600mg of MEM 1414 or placebo each day for seven days in a crossover design. Each subject will participate in two one-week treatment Phases, with a wash-out period of two to 10 weeks between each treatment Phase.
An important objective of the trial is to assess the efficacy of MEM 1414 on the late asthmatic reaction (LAR) following an inhaled allergen challenge, as measured by changes in forced expiratory volume in one second.
Additionally, effects of MEM 1414 on cytokine biomarkers of efficacy associated with the LAR, as well as effects on the early asthmatic reaction following allergen challenge, will be assessed, together with the safety and tolerability of the compound in this patient population.
MEM 1414, the company's lead molecule in its PDE4 inhibitor program, has demonstrated positive effects in preclinical models of inflammation and a favorable safety profile in multiple human clinical studies.
Vaughn Kailian, president and CEO of Memory Pharmaceuticals, said: "Our data for MEM 1414 supports development in a respiratory indication like asthma. This trial represents a significant milestone in the development of MEM 1414 and provides the opportunity to establish proof-of-concept in this important test of anti-inflammatory efficacy."
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