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news.Amira Pharmaceuticals, a small molecule pharmaceutical company, has announced that AM211, the company's internally discovered oral drug candidate for the treatment and control of inflammatory and allergic diseases linked to the arachidonic acid pathway, is on target for submission of an investigational new drug to the FDA by mid-2009 following the successful completion of good laboratory practices toxicity studies.
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AM211 is an oral, selective antagonist of the receptor DP2 (also known as CRTH2 or chemoattractant receptor-homologous molecule expressed on Th2 lymphocytes). DP2 is a high affinity receptor for prostaglandin (PG) D2 and, in humans, is implicated in Th2-dependent allergic inflammation.
Recent studies have shown that a DP2 antagonist has the potential to be an oral treatment for asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis, the company said.
Peppi Prasit, chief scientific officer of Amira, said: Our pre-clinical studies demonstrate that a low dose of AM211 is effective in several inflammatory/allergic models. Based on the pharmacokinetics and pharmacodynamics in preclinical models and its safety profile, we believe that AM211 has the potential to be an exciting next generation, once a day oral medication for respiratory diseases including COPD. In addition, we have a structurally distinct backup compound, AM461, about to enter GLP toxicity studies.