- Conference Call and Webcast Today at 4:30
p.m. EST
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced a
strategic redeployment of resources to support the development of
RNAi therapeutics that utilize the company’s new proprietary
subcutaneous (subQ) and extra-hepatic delivery systems. Arrowhead
will discontinue development of clinical stage drug candidates
ARC-520, ARC-521, and ARC-AAT, which utilize the DPCiv™, or EX1,
delivery vehicle. The company is hosting a conference call at 4:30
p.m. EST to discuss this decision.
Arrowhead remains committed to finding therapeutic options for
patients with chronic hepatitis B (HBV) infection and alpha-1
antitrypsin deficiency (AATD). The company intends to advance to
the clinic two previously unannounced HBV and AATD programs using
our subQ platform. Arrowhead has learned a great deal during prior
HBV and AAT studies that will help drive the subQ programs
efficiently.
Existing preclinical subQ and extra-hepatic programs such as
ARC-LPA and ARC-AMG1, which are partnered with Amgen, ARC-F12,
ARC-HIF2, and other unannounced programs are not affected by this
decision.
Because of the discontinuation of its existing clinical
programs, the company is reducing its workforce by approximately
30%, while maintaining full resourcing necessary to support current
and potential future partner-based programs and Arrowhead’s
burgeoning pipeline. This more streamlined structure should enable
the company to continue to develop its programs rapidly, and is
intended to extend its cash runway into 2019.
The decision to discontinue development of EX1-containing
programs was based primarily on two factors. First, during ongoing
discussions with regulatory agencies and outside experts, it became
apparent that there would be substantial delays in all clinical
programs that utilize EX1, while the company further explored the
cause of deaths in a non-clinical toxicology study in non-human
primates. Second, Arrowhead has made substantial advances in RNA
chemistry and targeting resulting in large potency gains for subQ
administered and extra-hepatic RNAi-based development programs. In
preclinical studies with the subQ platform, the company has
obtained depth and duration of target gene knockdown approaching
that of intravenously administered EX1-containing candidates, at
lower doses and with good safety margins.
The company believes it is prudent to focus its development
resources entirely on its subQ and extra-hepatic pipeline, which
includes programs in HBV, AAT, Factor 12, HIF-2alpha, and other
unannounced programs. In addition to its own pipeline, Arrowhead is
also focused on providing full resources to support its partnership
with Amgen and potential future partnerships for its subQ and
extra-hepatic delivery systems.
The tolerability of ARC-520, ARC-521, and ARC-AAT in human
clinical trials appeared to be favorable, and in the company’s
view, supported advancing the programs. EX1-containing candidates
have been administered over 800 times in more than 300 human study
subjects and patients and have been generally well tolerated, with
a small minority (6%) of infusions being associated with infusion
reactions. In addition, across the ARC-520, ARC-521, and ARC-AAT
clinical programs, laboratory values have not been deemed
indicative of drug induced organ toxicity.
In addition, each candidate was highly active against its
respective target. For example, data presented earlier this month
at The Liver Meeting® show that ARC-AAT achieved 90% knockdown of
serum AAT, which is believed to be near full suppression of liver
production of the protein, in a Phase 1 clinical study. For
ARC-520, it was previously reported that reductions in surface
antigen (HBsAg) of almost 99%, or 2 logs, were achieved after a
single dose. In subsequent multiple dose studies, for which data
have not yet been reported, reductions of almost 3 logs were
observed, with several patients being tracked that appear poised to
possibly seroclear HBsAg, representing potential function
cures.
However, due to likely regulatory considerations, as of this
announcement all patient recruitment for ARC-520, ARC-521, and
ARC-AAT has been halted and dosing discontinued. The company will
work together with investigators and clinical sites to ensure a
smooth transition of study closure and patient medical care.
Conference Call and Webcast Details
Investors may access a live audio webcast on the Company's
website at http://ir.arrowheadpharma.com/events.cfm. For analysts
that wish to participate in the conference call, please dial
855-215-6159 or 315-625-6887 and enter Conference ID 27048601.
A replay of the webcast will be available on the company’s
website approximately two hours after the conclusion of the call
and will remain available for 90 days. An audio replay will also be
available approximately two hours after the conclusion of the call
and will be available for 3 days. To access the audio replay, dial
404-537-3406 and enter Conference ID 27048601.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat
intractable diseases by silencing the genes that cause them. Using
a broad portfolio of RNA chemistries and efficient modes of
delivery, Arrowhead therapies trigger the RNA interference
mechanism to induce rapid, deep, and durable knockdown of target
genes. RNA interference, or RNAi, is a mechanism present in living
cells that inhibits the expression of a specific gene, thereby
affecting the production of a specific protein. Arrowhead’s
RNAi-based therapeutics leverage this natural pathway of gene
silencing.
For more information, please visit www.arrowheadpharma.com, or
follow us on Twitter @ArrowheadPharma. To be added to the Company's
email list and receive news directly, please visit
http://ir.arrowheadpharma.com/alerts.cfm.
Safe Harbor Statement under the Private Securities Litigation
Reform Act:
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our
actual results may differ materially and adversely from those
expressed in any forward-looking statements as a result of various
factors and uncertainties, including the safety and efficacy of our
product candidates, the duration and impact of regulatory delays in
our clinical programs, our ability to finance our operations, the
future success of our scientific studies, our ability to
successfully develop drug candidates, the timing for starting and
completing clinical trials, rapid technological change in our
markets, and the enforcement of our intellectual property rights.
Our most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q discuss some of the important risk factors
that may affect our business, results of operations and financial
condition. We assume no obligation to update or revise
forward-looking statements to reflect new events or
circumstances.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Pharmaceuticals, Inc.
Source: Arrowhead Pharmaceuticals, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20161129006166/en/
Arrowhead Pharmaceuticals, Inc.Vince Anzalone,
CFA626-304-3400ir@arrowheadpharma.comorInvestor
Relations:The Trout GroupChad
Rubin646-378-2947ir@arrowheadpharma.comorMedia:Russo
PartnersMatt Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.com
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