Trospectomycin Trials Close To Completion But Future Uncertain

Upjohn has essentially finished all of the pivotal clinical trials for its aminocyclitol antibiotic trospectomycin sulfate (U-63366F), and a dossier should be ready for submission to regulatory authorities in the near future. However, a spokesman for the company told the Marketletter at the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy that it was not clear whether the agent would continue in development at Upjohn or be licensed out.

Trospectomycin has been studied in a number of clinical indications, including uncomplicated gonococcal infections, gynecologic and pelvic infections, peritonitis and hospitalized pneumonia patients. At least two Phase III trials have been completed or are near completion in each of these areas, and there are also some smaller studies being carried out in pelvic inflammatory disease and Chlamydia trachomatis infections.

Upjohn developed trospectomycin with a view to improving on the profile of one of its other antibiotics, Cleocin/Dalacin (clindamycin), which has a similar spectrum of activity but which is gradually losing efficacy due to the emergence of resistance. Trospectomycin is superior to clindamycin in activity against enterococci and Gram negative bacteria. Studies presented at ICAAC revealed a 92% cure rate in combination with aztreonam in gynecologic/pelvic infections or peritonitis, and a 95% efficacy when given alone in gonococcal infections.