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news.Atox Bio has received orphan drug designation by FDA, for AB103 to treat necrotizing soft tissue infections (NSTI).
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AB103 is a short peptide acting as a CD28 modulator which regulates the inflammatory response in the host.
The drug candidate is said to have completed a phase 1 study and expects to go into a phase 2 proof of concept study to assess its clinical benefit.
Atox Bio CEO Dan Teleman said orphan drug designation for AB103 marks an important milestone for their clinical program.
"We look forward to continue working cooperatively with the agency to advance this potentially important new therapy through the clinical testing and regulatory process" Teleman added.