Orchid Chemicals & Pharmaceuticals (Orchid), a Chennai-based pharma major, has successfully completed in Europe a phase I trial of its orally administered PDE4 (phosphodiesterase 4 inhibitor) molecule OCID 2987 positioned for the treatment of inflammatory disorders including COPD (Chronic Obstructive Pulmonary Disease).
OCID 2987 is a proprietary novel PDE4 inhibitor with a distinct chemical scaffold. In per-clincal studies, OCID 2987 has demonstrated excellent preclinical pharmacological properties in models of inflammatory diseases, including respiratory diseases such as COPD and asthma. OCID 2987 has no interaction with more than 150 other targets tested; has a once a day pharmacokinetic profile and exhibits an excellent safety and toxicological profile.
The phase 1 study was conducted to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of OCID 2987 at escalating single or repeated doses on health male volunteers, OCID 2987 was well tolerated up to the highest doses administered in both single and repeat dose studies and did not demonstrate a potential for nausea/emesis, a common unacceptable side-effect with most PDE4 inhibitors. There were no serious adverse events or any cardiac safety concerns reported in the study.
K Raghavendra Rao, chairman and managing director, Orchid Chemicals & Pharmaceuticals Ltd, said, "We are extremely pleased with the results of the phase 1 study of OCID 2987 and are committed to moving the molecule further in clinical development for the treatment of COPD and other inflammatory diseases. Given the positive results achieved in the earlier animal trials and now the phase I trial, we are confident of successfully completing the further trials as we move forward."
Orchid's drug discovery efforts are conducted through its wholly-owned subsidiary, Orchid Research Laboratories Limited.