Cellceutix files pre-IND papers for psoriasis drug

Beverly, Mass. - Biopharmaceutical firm Cellceutix Corp. has filed a pre-IND (investigational new drug) submission with the Food and Drug Administration on Prurisol (KM-133), which the company is developing as a treatment for psoriasis.

The submission provides the FDA with information about the drug to support a pre-IND meeting. According to a MarketWire report, Cellceutix is requesting the meeting for guidance to attain the agency’s approval to begin proposed clinical trials in advanced stages. The meeting’s ultimate goal is to gain a full understanding of the studies required to support a New Drug Application (NDA) filing for Prurisol.

MarketWatch quotes Cellceutix Chief Scientific Officer Krishna Menon, Ph.D., as saying, “Prurisol is an ester of an FDA-approved drug that is used for different indications today. Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials. ... As part of our planned meeting with the FDA, we will also discuss Prurisol’s eligibility for fast-track review, a designation that will further expedite our efforts to bring Prurisol to market.”

Cellceutix has previously disclosed images of mice treated with Prurisol to demonstrate its effectiveness as compared to methotrexate, a standard psoriasis treatment.

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