Hillstream Enters into an Exclusive Option Agreement to Acquire a Clinical Stage Asset for Chronic Pruritis
11 Septembre 2023 - 5:51PM
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 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,” said Randy Milby, CEO of Hillstream. “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.”
Webcast details
Hillstream BioPharma will host a webcast on Monday September
11th at 4:30 pm ET to describe this opportunity in more detail.
Participant Dial-In: 877-407-8835 / +1
201-689-8779. Click here for participant International Toll-Free
access numbers
Webcast: https://event.webcasts.com/starthere.jsp?ei=1633694&tp_key=3823baed9e
Callme™: https://hd.choruscall.com/InComm/?callme=true&passcode=13741139&h=true&info=company-email-jobtitle&r=true&B=6
About Hillstream BioPharma Inc.Hillstream
BioPharma, Inc. is a biotechnology company developing a focused
portfolio of therapeutic candidates targeting drug resistant and
devastating cancers. The Company’s emerging immuno-oncology
pipeline is led by HSB-3215, a novel anti-HER2/HER3 monoclonal
antibody targeting unique epitopes with a novel mechanism of
action. The erbB/HER family of cell surface proteins include
well-known and validated drug targets including HER2 and HER3 found
in multiple solid tumors, including breast, lung, GYN,
endocrinological and CNS. Hillstream has a license agreement with
OmniAb, Inc. to access the company’s antibody discovery technology
platform against specified targets. For more information, please
visit: www.hillstreambio.com.
Forward Looking StatementsCertain statements in
this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
may be identified using words such as “anticipate,” “believe,”
“forecast,” “estimated” and “intend” or other similar terms or
expressions that concern Hillstream’s expectations, strategy, plans
or intentions. These forward-looking statements are based on
Hillstream’s current expectations and actual results could differ
materially. There are several factors that could cause actual
events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, clinical trials involve a lengthy and expensive process
with an uncertain outcome, and results of earlier studies and
trials may not be predictive of future trial results; our clinical
trials may be suspended or discontinued due to unexpected side
effects or other safety risks that could preclude approval of our
product candidates; risks related to business interruptions,
including the outbreak of COVID-19 coronavirus, which could
seriously harm our financial condition and increase our costs and
expenses; dependence on key personnel; substantial competition;
uncertainties of patent protection and litigation; dependence upon
third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations.
Investors should read the risk factors set forth in our Form 10-K
for the year ended December 31, 2022, and our periodic reports
filed with the Securities and Exchange Commission. While the list
of factors presented here is considered representative, no such
list should be considered to be a complete statement of all
potential risks and uncertainties. Unlisted factors may present
significant additional obstacles to the realization of
forward-looking statements. Forward-looking statements included
herein are made as of the date hereof, and Hillstream does not
undertake any obligation to update publicly such statements to
reflect subsequent events or circumstances. “Picobody” is a
trademark of Crystal Bioscience, Inc., a unit of OmniAb, Inc.
Investor Relations
ContactEmail: investorrelations@hillstreambio.comwww.hillstreambio.com
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