Tharimmune Inc THAR has executed an exclusive worldwide licensing agreement with Avior Inc. to develop, market, and commercialize a clinical-stage asset, AV104 (to be renamed TH104).
TH104 has a dual mechanism of action affecting receptors known to suppress chronic, debilitating pruritis or "uncontrollable itching."
The company intends to first seek approval in an orphan disease for moderate-to-severe cholestatic pruritis (itch) in patients with primary biliary cholangitis (PBC), an orphan liver disease.
TH104 is embedded with the active pharmaceutical ingredient onto a proprietary transdermal buccal film, which easily adheres to the inside of the mouth.
The active molecule has a dual mechanism of action affecting both the µ -opioid receptor and the kappa opioid receptor and inhibiting IL-17 inflammatory cytokine expression.
Tharimmune expects to complete a phase 1 pharmacokinetic trial and a phase 2 proof-of-concept efficacy study in PBC patients suffering from chronic pruritis over approximately 12 months after aligning with the FDA on trial design.
Tharimmune believes TH104 may also be used for treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver-related and non-liver-related conditions, including fatty and alcoholic diseases, non-alcoholic liver diseases, and certain types of hepatitis.
Price Action: THAR shares are up 37.50% at $0.22 on the last check Tuesday.
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