Arris Pharmaceutical has released the final data from its Phase IIa clinical trial with its tryptase inhibitor, APC-366, for the treatment of asthma. Preliminary data were released earlier this year (Marketletter May 27).
In an allergen-induced model of asthma, APC-366 was seen to protect against a hyperbronchial response to histamines, and against allergen-induced early and late airway responses. Subjects administered low-dose APC-366 (2.5mg tid) demonstrated a significant 42% protection, while the high-dose group (5mg tid) saw a 62% protection, against late airway response to allergens, although the latter was not statistically significant.
A further placebo-controled, double-blind, crossover Phase IIa trial has been approved and will enroll 16 mild asthmatics who will be hospitalized for two five-day periods. Patients will be treated prophylactically and then challenged with allergen and histamine to determine their early and late airway reactions, and the hyperresponsive phase of the condition.
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