Xentria submitted the request — in the form of an investigational new drug (IND) application — to the U.S. Food and Drug Administration (FDA) on Feb. 26. The application includes various preclinical data about the investigational medication’s biological activity and safety profile, as well as details of how the therapy would be manufactured and given to trial participants.
The main purpose of the IND application is to share with the FDA data that indicates XTMAB-16 would be safe for human use. If the FDA approves this application, Xentria will be allowed to begin clinical trials of XTMAB-16. The company expects trials could begin as early as the first half of this year, though it also is possible the FDA will request additional information before making a final decision.
“We are excited about advancing XTMAB-16 into the clinical phase as we believe that this novel biologic product will be key in the treatment of [sarcoidosis]. We anticipate beginning our Phase 1 trial as soon as possible after FDA review,” Thomas Shea, president of Xentria, said in a press release.
XTMAB-16 is an antibody-based therapy that works by inhibiting TNF-alpha, a pro-inflammatory signaling molecule that is known to contribute to chronic inflammation and granuloma (immune cell clumps) formation in people with sarcoidosis. By blocking this pro-inflammatory molecule, XTMAB-16 is expected to lessen the disease’s symptoms.
Currently, there are no TNF-alpha inhibitors approved in the U.S. for treating sarcoidosis However, this type of medication is frequently used off-label to treat the disease, as demonstrated by data from a recent study that found approximately one in 10 people with sarcoidosis are treated with off-label TNF-alpha inhibitors.
“With no TNF-α inhibitor currently approved for the treatment of sarcoidosis, this IND application brings us a step closer to a new treatment option for underserved sarcoidosis patients,” Shea said.
Last year, the FDA granted orphan drug designation to XTMAB-16 for the treatment of sarcoidosis. This designation is given to investigational therapies that have the potential to substantially improve care for rare diseases. It is meant to hasten the therapy’s development by providing the developer with regulatory support and financial incentives, most notably seven years of market exclusivity if the medication is approved.
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