Glenmark completes phase I trials for new molecule

Glenmark Pharmaceuticals today said its molecule, which intends to target pain and respiratory disorders, has completed first phase trials in the Netherlands.

The company said its novel chemical entity (NCE)— GRC 17,536— has completed phase I trials (single ascending dose and multiple ascending dose) in the Netherlands, Glenmark Pharma said in a statement.

The overall exposures achieved in humans compares favorably with the exposure required for maximum efficacy in the animal models, which suits entry into further clinical development, it added.

Commenting on the development Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said: "This is another potential first-in-class molecule indicated for both pain and respiratory conditions. There is a huge unmet medical need in both therapeutic areas globally."

GRC 17536 is a global first-in-class programme targeting the TRPA1 receptor antagonists for pain and respiratory disorders, the company said.

TRPA1 belongs to Transient Receptor Potential (TRP) family of ion channels, which have generated a lot of interest as pain targets due to their distinguishing role in peripheral and/or central pain signal transmission, it added.

"Glenmark has now planned to initiate phase II studies in pain indications. The company has filed regulatory submissions with the MHRA, UK, and BfArM, Germany, to initiate Phase 2 a proof-of-concept study in patients with painful diabetic peripheral neuropathy," it said.

Subject to regulatory approvals, the projected start of the study is March 2012, it said. Also, GRC 17536 would be tested via the inhaled route for use in the respiratory indications.

Shares of Glenmark were trading at Rs 302 on the BSE, up 0.9% from its previous close.