Anticipate completion of Phase 1 & Phase 2 clinical trials in chronic pruritis over the next approximately 12 months
Seeking first approval in an orphan disease, PBC, for the treatment of moderate to severe chronic pruritis in which more than 70% of patients suffer from chronic pruritis
BRIDGEWATER, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (NASDAQ:HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancer announces an exclusive option agreement to acquire a clinical stage asset, AV104, with a recently approved IND. AV104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or "uncontrollable itching". The Company intends to first seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis in patients with primary biliary cholangitis (PBC), a rare form of liver disease with no known cure in which more than 70% of patients suffer from chronic pruritis.
Embedded onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth, AV104's key features make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. AV104's active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the body's itch circuitry.
When the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs in patients suffering from chronic pruritis. Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the drug-coated ...