Aravive Initiates a Phase 2a Clinical Trial of AVB-500 in Patients with Kidney Fibrosis
December 20 2019 - 8:00AM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical
company, today announced that the company has begun enrolling
patients in the Phase 2a clinical trial of AVB-500 in patients with
kidney fibrosis, specifically IgA Nephropathy (IgAN) (NCT04042623).
“We are very pleased to initiate this first trial of AVB500 in
patients with renal fibrosis,” said Gail McIntyre Ph.D., DABT, CSO
at Aravive. “GAS6 is more highly expressed in human IgAN tissues
than normal kidney tissue, GAS6 levels correlate with severity of
the disease and inhibition of the pathway preclinically has
demonstrated a positive effect.”
This is an open-label Phase 2a clinical study designed to
evaluate the safety and efficacy of AVB500 in patients with
biopsy-proven IgAN and excreting 1-3 grams of protein daily in
their urine. The primary endpoints will be safety of AVB500 in the
population and efficacy of AVB500 treatment on decreasing the
amount of protein in the urine.
IgAN, also known as Berger's disease, is a kidney disease that
occurs when an antibody called immunoglobulin A builds up in the
kidneys. This results in local inflammation that, over time,
damages the kidneys. Preclinical studies have demonstrated that
GAS6 acts as a mitogen, stimulating mesangial cell proliferation
through binding to its cell-surface receptor AXL and an AXL decoy
protein can inhibit mesangial cell proliferation by interfering
with the GAS6/AXL pathway. IgA nephropathy usually progresses
slowly over years and patients can develop end-stage kidney
failure, requiring dialysis. No cure exists for IgAN, but certain
medications can slow its course.
About AVB-500AVB-500 is a therapeutic
recombinant fusion protein that has been shown to neutralize GAS6
activity by binding to GAS6 with very high affinity. In doing so,
AVB-500 selectively inhibits the GAS6-AXL signaling pathway. In
preclinical studies, GAS6-AXL inhibition has shown anti-tumor
activity, bothas a single agent and in combination with a variety
of anticancer therapies including radiation therapy,
immuno-oncology agents and chemotherapeutic drugs that affect DNA
replication and repair. Increased expression of AXL and GAS6 in
tumors is correlated to poor prognosis and survival, and has been
implicated in therapeutic resistance to conventional
chemotherapeutics and targeted therapies.
Aravive reported positive data from the expansion cohort in the
Phase 1b portion of a Phase 1b/2 clinical trial of AVB-500 in
platinum-resistant recurrent ovarian cancer. AVB-500 continues to
be well tolerated with no dose limiting toxicities. An
investigator-sponsored Phase 1 study of AVB-500, in combination
with durvalumab in patients with platinum-resistant recurrent
epithelial ovarian cancer, is also ongoing. Based on AVB-500’s
safety profile and specifically targeted mechanism of action, this
drug candidate has the potential to be used both in combination
with existing therapies, as well as a maintenance drug. The U.S.
Food and Drug Administration granted Fast Track Designation to
AVB-500 in platinum-resistant recurrent ovarian cancer.
About AraviveAravive, Inc. (Nasdaq: ARAV) is a
clinical-stage biopharmaceutical company developing treatments
designed to halt the progression of life-threatening diseases,
including cancer and fibrosis. Aravive’s lead product candidate,
AVB-500, is an ultra-high affinity decoy protein that targets the
GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500
starves the AXL pathway of its signal, potentially halting the
biological programming that promotes disease progression. AXL
receptor signaling plays an important role in multiple types of
malignancies by promoting metastasis, cancer cell survival,
resistance to treatments, and immune suppression. The GAS6-AXL
signaling pathway also plays a significant role in fibrogenesis.
Aravive is evaluating AVB-500 in platinum-resistant ovarian cancer
and kidney fibrosis and intends to expand development into
additional oncology and fibrotic indications. Aravive is based in
Houston, Texas and received a Product Development Award from the
Cancer Prevention & Research Institute of Texas (CPRIT) in
2016. For more information, please visit www.aravive.com.
Forward-Looking StatementsThis communication
contains forward-looking statements (including within the meaning
of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities
Act of 1933, as amended), express or implied, concerning the
potential of AVB-500 to be used both in combination with existing
therapies, as well as a maintenance drug, the potential of AVB-500
to halt the biological programming that promotes disease
progression and the expansion of the development of AVB-500 into
additional oncology and fibrotic indications. Forward-looking
statements are based on current beliefs and assumptions, are not
guarantees of future performance and are subject to risks and
uncertainties that could cause actual results to differ materially
from those contained in any forward-looking statement as a result
of various factors, including, but not limited to, risks and
uncertainties related to: the Company’s ability to expand
development in 2019 into additional oncology and fibrotic
indications, the Company’s dependence upon AVB-500, AVB-500’s
ability to have favorable results in clinical trials or receive
regulatory approval, potential delays in the Company's clinical
trials due to regulatory requirements or difficulty identifying
qualified investigators or enrolling patients; the risk that
AVB-500 may cause serious side effects or have properties that
delay or prevent regulatory approval or limit its commercial
potential; the risk that the Company may encounter difficulties in
manufacturing AVB-500; if AVB-500 is approved, risks associated
with its market acceptance, including pricing and reimbursement;
potential difficulties enforcing the Company's intellectual
property rights; the Company's reliance on its licensor of
intellectual property and financing needs. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in the Company's
Annual Report on Form 10-K and Form 10-K/A for the fiscal year
ended December 31, 2018, recent Current Reports on Form 8-K and
subsequent filings with the SEC. Except as required by applicable
law, the Company undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts for Aravive:Investors:Christina TartagliaStern Investor
Relationschristina@sternir.com
Media:Heidi ChokeirCanale
Communicationsheidi@canalecomm.com 619-203-5391Source:
Aravive,
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