Hillstream Enters Exclusive Option Agreement for Acquisition of Clinical-stage Therapy Addressing Chronic Pruritis
Tuesday, September 12, 2023
Hillstream BioPharma, Inc. (Nasdaq: HILS) is a biotechnology firm with a focus on developing therapeutic candidates to combat drug-resistant cancers. They have recently announced an exclusive option agreement to acquire AV104, a clinical-stage asset with an approved IND (Investigational New Drug). AV104 targets chronic and debilitating pruritus, commonly known as uncontrollable itching, and has a dual mechanism of action.
Hillstream's primary objective is to secure approval for AV104 in the treatment of moderate to severe cholestatic pruritus in patients suffering from primary biliary cholangitis (PBC), a rare and incurable liver disease where over 70% of patients experience chronic pruritus.
AV104 stands out due to its innovative delivery system – a proprietary transdermal buccal film that adheres easily to the inside of the mouth. The active molecule, nalmefene, works by affecting both the µ-opioid receptor and the kappa opioid receptor, in addition to inhibiting the expression of the inflammatory cytokine IL-17. These receptors are implicated in the body's itch circuitry and are known to play a role when imbalances occur in diseased conditions like chronic pruritus.
The buccal delivery method ensures that nalmefene enters the bloodstream by adhering to the drug-coated film inside the cheek, where it biodegrades rapidly, facilitating drug absorption. This delivery method bypasses the liver's first-pass metabolism, resulting in higher drug concentrations in the skin. Hillstream's plans include conducting a bridging pharmacokinetic phase 1 trial and a phase 2 proof-of-concept study in PBC patients, expected to be completed over the next year following alignment with the US FDA.
Hillstream envisions broader applications for AV104, including treating chronic pruritic conditions associated with various liver diseases, as well as non-liver-related conditions such as fatty liver diseases, alcoholic liver diseases, non-alcoholic liver diseases, and specific types of hepatitis. Chronic pruritus is a significant issue in liver diseases, as well as in chronic kidney diseases, hemodialysis, and atopic dermatitis.
Randy Milby, CEO of Hillstream, emphasized the company's transformative journey over the past year and underscored the exclusive option agreement as a significant step in their evolution into a patient-centered biotechnology organization. This strategic move reflects Hillstream's commitment to advancing clinical development and addressing critical unmet medical needs.
