The Company intends to first seek approval for AV104 in an orphan disease for the treatment of moderate to severe cholestatic pruritis in patients with primary biliary cholangitis.

Hillstream BioPharma, Inc. is set to acquire AV104 for chronic pruritis.

AV104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis. 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 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. Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the drug-coated film inside the cheek where the film biodegrades in minutes and the drug is absorbed. The buccal delivery of the drug bypasses the liver’s first-pass metabolism thus creating high drug concentrations in the skin, an added benefit for treating conditions in which the liver may be impaired. 

The Company intends to complete a bridging pharmacokinetic phase 1 trial and a phase 2 proof-of-concept in PBC patients over approximately the next 12 months after alignment with the US FDA.

Hillstream believes AV104 has expansion opportunities in treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related and as non-liver related diseases including fatty and alcoholic liver diseases, non-alcoholic liver diseases and certain types of hepatitis. Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis. and atopic dermatitis.

“The past year has been a period of transformational change for our company,” says Randy Milby, CEO of Hillstream, in a news release. “This exclusive option allows the company to bring a clinical-stage asset into the organization as we shift into a patient-focused biotechnology organization. This signifies our next step as we grow into a business model focused on clinical development.”