Atox Bio Granted Orphan Drug Designation for AB103
The drug candidate has completed a Phase I study and expects to go into a Phase II proof-of-concept study to assess its clinical benefit.
Clinical stage biotechnology company Atox Bio has been granted orphan drug designation by the US FDA for AB103, used to treat necrotising soft tissue infections.
AB103 is a short peptide that acts as a CD28 modulator, regulating the inflammatory response in the host.
The drug candidate has completed a Phase I study and expects to go into a Phase II proof-of-concept study to assess its clinical benefit.
Atox Bio CEO Dan Teleman said, "The FDA's decision to grant AB103 orphan drug designation is another important milestone for our clinical program and underscores the urgency of the need for new treatments for this life threatening infection."
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