LAB CGRP, as a potential drug, has demonstrated in preclinical studies a profile that could make it an ideal anti-asthmatic drug candidate.
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 objective of this phase II study was 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. The study was also designed to evaluate the safety and tolerability of LAB CGRP in asthma patients.
Each patient received one dose of LAB CGRP, one dose of Salbutamol sulphate and one dose of placebo. Study agents were compared in terms of absolute provocative concentration (PC20) of methacholine causing at least 20% fall in forced expiratory ventilation volume. On average, the PC20 with LAB CGRP was approximately two-fold as compared to placebo.
“Now that we have successfully completed this first phase II study confirming clinical activity we can confidently pursue additional studies to explore dose optimization and anti-inflammatory properties of LAB CGRP.” commented Dr Halvor Jaeger, CEO of LAB International.