- HTX-011 to be evaluated in approximately 60 patients undergoing
inguinal hernia repair
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jul. 23, 2015--
Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused
on improving the lives of patients by developing best-in-class medicines
that address major unmet medical needs, today announced that it has
initiated a second Phase 2 clinical trial of HTX-011. HTX-011, which
utilizes Heron’s proprietary Biochronomer® drug delivery
technology, is a long-acting formulation of the local anesthetic
bupivacaine in a fixed-dose combination with the anti-inflammatory
meloxicam for the prevention of post-operative pain.
The placebo-controlled, dose-finding, Phase 2 clinical trial in
approximately 60 patients undergoing inguinal hernia repair will
evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg
of bupivacaine combined with meloxicam, compared to placebo. HTX-011 is
also currently being evaluated in a placebo-controlled, dose-finding,
Phase 2 clinical trial in patients undergoing bunionectomy. In a
previously completed, placebo-controlled, Phase 1 clinical trial,
HTX-011 achieved the desired pharmacokinetic profile for both
bupivacaine and meloxicam, with therapeutically relevant plasma
bupivacaine levels sustained for 2-3 days.
“We are extremely pleased to be expanding our Phase 2 development
program for HTX-011 with the initiation of a study in patients
undergoing hernia repair,” commented Barry D. Quart, Pharm.D., Chief
Executive Officer of Heron. “Our ongoing clinical trial in patients
undergoing bunionectomy is progressing extremely well, supporting the
expansion of the HTX-011 Phase 2 development program. We look forward to
reporting data from both the bunionectomy study and the hernia repair
study in the second half of 2015.”
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is a long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the prevention of post-operative pain.
By delivering sustained levels of both a potent anesthetic and an
anti-inflammatory agent directly to the site of tissue injury, HTX-011
was designed to deliver superior pain relief while potentially reducing
the need for systemically administered pain medications such as opioids,
which carry the risk of harmful side effects, abuse and addiction. In a
Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic
profile for both bupivacaine and meloxicam. Specifically,
therapeutically relevant plasma bupivacaine levels were sustained for
2-3 days. The anesthetic effects of HTX-011 persisted through 96 hours,
which closely correlated with plasma bupivacaine concentrations, and
HTX-011 was well-tolerated with no serious adverse events. Heron is
currently conducting two placebo-controlled, dose-finding, Phase 2
clinical trials of HTX-011 in patients undergoing bunionectomy or
inguinal hernia repair. Heron expects to report results from both of
these trials in the second half of 2015.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company focused on improving
the lives of patients by developing best-in-class medicines that address
major unmet medical needs. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents. Heron’s goal is to build on
therapeutics with well-known pharmacology by improving their
tolerability and efficacy as well as broadening their potential field of
use. Heron is currently developing four pharmaceutical products for
patients suffering from cancer or pain. SUSTOL® is Heron’s
injectable, extended-release formulation of granisetron that is being
developed for the prevention of both acute and delayed
chemotherapy-induced nausea and vomiting (CINV) associated with
moderately emetogenic chemotherapy (MEC) or highly emetogenic
chemotherapy (HEC). CINV is one of the most debilitating side effects of
chemotherapy and is a leading cause of premature discontinuation of
cancer treatment. Heron recently reported positive, top-line results
from its Phase 3 MAGIC study and resubmitted its New Drug Application
(NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) in July
2015. HTX-019, also being developed for the prevention of CINV, has the
potential to become the first polysorbate 80-free, intravenous
formulation of aprepitant, a neurokinin-1 (NK1) receptor
antagonist. Heron intends to file an NDA for HTX-019 using the 505(b)(2)
regulatory pathway in the second half of 2016. HTX-011, Heron’s
long-acting formulation of the local anesthetic bupivacaine in a
fixed-dose combination with the anti-inflammatory meloxicam, is
currently being evaluated in two Phase 2 trials for the prevention of
post-operative pain. Heron expects to report results from both of these
trials in the second half of 2015. HTX-003, a long-acting formulation of
buprenorphine, is being developed for the potential management of
chronic pain and opioid addiction. All of Heron’s product candidates
utilize Heron’s innovative science and technology platforms, including
its proprietary Biochronomer® drug delivery technology, which
can deliver therapeutic levels of a wide range of otherwise short-acting
pharmacological agents over a period of days to weeks with a single
injection.
For more information, visit www.herontx.com.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, but
are not limited to, those associated with: the acceptance of the
Company’s resubmission of its New Drug Application (NDA) for SUSTOL®,
whether the U.S. Food and Drug Administration (FDA) approves the SUSTOL
NDA as submitted or supports as broad of a labeled indication for SUSTOL
as requested, the progress in the research and development of HTX-019,
HTX-011, HTX-003 and our other programs, including the timing of
preclinical, clinical, and manufacturing activities, safety and efficacy
results from our studies that may not justify the pursuit of further
development of our product candidates, the launch and acceptance of
SUSTOL and new products generally, our financial position and our
ability to raise additional capital to fund operations, if necessary, or
to pursue additional business opportunities, strategic business
alliances we may pursue or the potential acquisition of products or
technologies, and our ability to grow our organization to sustain the
commercial launch for SUSTOL, and other risks and uncertainties
identified in the Company's filings with the Securities and Exchange
Commission. Forward-looking statements reflect our analysis only on
their stated date, and Heron undertakes no obligation to update or
revise these statements except as may be required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150723005450/en/
Source: Heron Therapeutics, Inc.
Investor Relations Contact:
Heron Therapeutics, Inc.
Jennifer
Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, 650-366-2626
Pharm.D., Chief
Executive Officer
