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news.Callisto Pharmaceuticals, through its wholly-owned subsidiary, Synergy Pharmaceuticals has filed an investigational new drug application with the FDA for SP-304 for the treatment of chronic constipation and constipation-predominant irritable bowel syndrome.
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Pending clearance by the FDA, Callisto intends to initiate an SP-304 (also called Guanilib) Phase I clinical trial in second quarter of 2008 to evaluate the safety, pharmacokinetic, and pharmacodynamic properties.
Gary Jacob, CEO of Callisto, and chairman of Synergy Pharmaceuticals, said: “There is strong clinical evidence of efficacy and safety for this class of compounds and we are hopeful that this product may address the significant unmet medical need of patients suffering from chronic constipation and irritable bowel syndrome (IBS). There are only two compounds presently in this class, our drug, and linaclotide, a drug that is currently being developed by Microbia and Forest Laboratories to treat GI disorders. We believe that SP-304 has the potential to be the best in class.”