Glenmark Pharmaceuticals S.A (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd (India), has filed for Phase 1 clinical trials for GRC 3886, its leading PDE4 compound (a novel drug candidate for Chronic Obstructive Pulmonary Disorder (COPD) and Asthma), with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
The phase 1 study, which is expected to commence in September 2004, will be conducted in UK by Quintiles, a leading global CRO (Clinical Research Organisation).
The objective of this study is to assess the safety and bioavailability of GRC 3886 in humans. The pharmacodynamics will also be assessed in human whole blood using a surrogate marker (LPS induced TNF alpha inhibition). Glenmark has also commissioned preliminary efficacy models to be conducted during Phase I to evaluate the pharmacodynamic response to Allergen-induced bronchial challenge and to assess the bronchial hyperresponsiveness in patients with mild asthma, company informed in a release.