Pharmaceutical Business review

Lab initiates mid-phase asthma study

Lab-CGRP is a 37 amino acid natural neuropeptide produced in the lung in response to allergic stimuli. As a potential drug, it has demonstrated in preclinical studies a profile that could make it an ideal anti-asthmatic drug candidate with bronchodilatory, bronchoprotecting and anti-inflammatory properties.

The objectives of this randomized, double blind, cross-over phase II study are to investigate the protective efficacy of Lab-CGRP on metacholine induced bronchial hyper-responsiveness in adult patients with mild to moderate asthma, to compare this efficacy to salbutamol and placebo, and to evaluate the safety and tolerability of Lab-CGRP in asthma patients. The trial is expected to be completed in the third quarter of 2006.

“We are initiating this trial with confidence and excitement and look forward to demonstrating efficacy in asthma patients following compelling results previously obtained in preclinical studies. In these studies, Lab-CGRP completely abolished airway hyper-responsiveness to metacholine and allergen challenges,” commented Dr Halvor Jaeger, CEO of Lab International.

“Demonstrating the bronchodilatory, anti-inflammatory and broncho-protective properties in patients would represent a significant benefit over the usual combination asthma therapies,” continued Dr Jaeger.