LAB International Inc. (LAB), a drug development company focused on developing therapies for the inhalation market, has announced positive results from the first phase II clinical trial of its LAB CGRP product.
LAB CGRP showed statistically significant broncho-protective effects compared to placebo and a similar safety profile to placebo except for transient and mild headaches and flushing in some of the patients.
The objectives of this randomised, double blind, cross-over phase II study were 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 enrolled a total of 12 patients and reached statistical difference.
Each patient received one dose of LAB CGRP (5mg), one dose of Salbutamol sulphate (500µg) and one dose of placebo. The doses were given in a randomised order and study agents were compared in terms of absolute provocative concentration (PC20) of methacholine causing at least 20 per cent fall in forced expiratory ventilation volume. LAB CGRP increased PC20 in a majority of patients (7 out of 12) while Salbutamol and placebo respectively achieved 11 and 2 out of 12. On average, the PC20 with LAB CGRP was approximately two-fold as compared to placebo (geometric mean 1.97 mg/ml, and 0.95 mg/ml, respectively p<0.05).
"We are very pleased to have demonstrated for the first time in human asthmatics the CGRP bronchodilatory efficacy. Now that we have successfully completed this first phase II study confirming clinical activity we can confidently pursue additional studies to explore dose optimisation and anti-inflammatory properties of LAB CGRP." commented Dr Halvor Jaeger, CEO of LAB International.
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.