- Olorinab investigated in three doses, 10 mg,
25 mg, and 50 mg, for abdominal pain associated with IBS-C &
IBS-D
- Trial did not meet primary endpoint in broad
study population
- Moderate to severe pain population at 50 mg
showed statistically significant, clinically meaningful improvement
vs placebo in Average Abdominal Pain Score (AAPS)
- Olorinab was generally well tolerated
consistent with the safety profile of previous trials
- Company to evaluate possible strategic
options for program
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced
topline results from the randomized, double-blind,
placebo-controlled Phase 2b CAPTIVATE clinical trial evaluating
three doses of olorinab, a novel, oral, peripherally acting, highly
selective, full agonist of the cannabinoid receptor 2 (CB2), in
participants with abdominal pain due to Irritable Bowel Syndrome
(IBS).
The CAPTIVATE trial randomized a total of 273 participants and
was conducted in study sites across the United States. The results
show that, although olorinab was well tolerated, it did not meet
the primary efficacy endpoint of statistically significant
improvement in the overall AAPS from baseline to week 12.
A pre-specified analysis assessed participants with baseline
AAPS ≥ 6.5 (median), representing those with moderate to severe
pain. This subgroup accounted for 50% of the overall study
population. Within this subgroup, the 50 mg treatment group showed
a clinically meaningful1 and statistically significant (p=0.01)
reduction in AAPS of 1.64 points compared to placebo and 3.93
points from baseline at week 12.
Olorinab was generally safe and well tolerated in the study,
consistent with the safety profile of previous trials.
Discontinuation rates and adverse events were similar to placebo,
notably with no worsening of bowel habits and no treatment
interruptions. There were no serious adverse events observed in the
study.
“The CAPTIVATE Study was the first study to examine a full
agonist of CB2 in IBS pain. As a Phase 2 trial we were evaluating
safety in this population as well as looking for an initial signal
of efficacy,” said Paul D. Streck, MD, Arena’s Senior Vice
President, Clinical Development, and Chief Medical Officer. “We are
encouraged by the signal in this moderate to severe group and look
forward to sharing the full data from this well-executed trial at
an upcoming medical meeting.”
“There is a significant unmet need for a novel, non-opioid drug
that treats moderate to severe pain with IBS, while not worsening
associated constipation or diarrhea. While these data will need to
be replicated in a Phase 3 registration program, the data from the
CAPTIVATE Study are promising and give me hope that we may have a
valuable therapeutic option in the future,” said Lin Chang, MD,
Vice-Chief of the Vatche and Tamar Manoukian Division of Digestive
Diseases at UCLA.
“These data are quite promising. There appears to be a strong
signal that the drug has effect in abdominal pain in the moderate
to severe population at the 50 mg dose. Importantly, the magnitude
of effect in this cohort surpasses the bar for clinically
meaningful benefit,” said Anthony Lembo, MD, Professor of Medicine
at Harvard Medical School and Director of the GI Motility
Laboratory at Beth Israel Deaconess Medical Center in Boston,
MA.
“We expect to evaluate possible strategic options for olorinab,
while maintaining our commitment to the GI community and remaining
focused on advancing our clinical programs for etrasimod in
ulcerative colitis, Crohn’s disease, and eosinophilic esophagitis,”
added Amit Munshi, President and Chief Executive Officer at Arena.
“We want to thank the participants, clinicians, site staff, and the
Arena team who participated in this important trial.”
About CAPTIVATE
CAPTIVATE is a Phase 2b, multi-center, randomized, double-blind,
placebo-controlled, 12-week study of olorinab in 273 study
participants with irritable bowel syndrome (IBS) experiencing
abdominal pain. The study will evaluate change in abdominal pain in
participants with the clinical diagnosis of IBS with predominant
constipation (IBS-C) or diarrhea (IBS-D). The primary objective of
this trial is to assess the safety and efficacy of olorinab
administered three times daily (TID). The primary endpoint is
improvement in the weekly Average Abdominal Pain Score (AAPS) from
baseline. The CAPTIVATE trial is being conducted at approximately
70 study sites across the United States. Additional information on
this clinical trial can be found at clinicaltrials.gov
(NCT04043455).
About Olorinab
Olorinab (APD371) is an oral, peripherally acting, highly
selective, full agonist of the cannabinoid receptor 2 (CB2).
Olorinab is an internally discovered investigational drug candidate
that Arena is exploring for development in several indications,
with an initial focus on visceral pain in gastrointestinal
disorders. This compound, through its selectivity for CB2, versus
the cannabinoid receptor 1 (CB1), was designed to provide pain
relief while minimizing the risk of psychoactive adverse
effects.
Olorinab is an investigational compound that is not approved for
use in any country.
About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose –
deliver our important medicines to patients.
In a rapidly changing global market, we work with a sense of
urgency every day to understand the needs of all our stakeholders,
identify bold, sometimes disruptive, ideas to get our medicines to
patients, and relentlessly execute until it's done.
We are developing a richly diversified portfolio of therapeutic
candidates targeting gastroenterology, dermatology and cardiology.
Our pipeline includes four investigational medicines in eight
indications and eleven ongoing or planned clinical trials. To fuel
our growth, we are unlocking the value of our historical GPCR
research with a sustainable discovery engine for broad portfolio
expansion.
ARENA - Care More. Act Differently.
_________________________________________________
1 Minimal clinically important difference is defined as
improvement of at least 2.2 from baseline per Spiegel B et al.
“Measuring irritable bowel syndrome patient-reported outcomes with
an abdominal pain numeric rating scale.” Aliment Pharmacol Ther.
2009;30(11-12):1159-1170.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements may be identified by words such as
"will," "look forward," "upcoming," "committed," "objective,"
"designed to," and "planned," and include, without limitation,
statements about the following: olorinab's potential utility and
clinical benefits, Arena's plans to present additional data from
the CAPTIVATE trial at a future medical meeting, the exploration of
strategic options for olorinab, and Arena's purpose, work,
understanding, ideas, execution, pipeline, planned clinical trials,
discovery engine, and portfolio expansion. For such statements,
Arena claims the protection of the Private Securities Litigation
Reform Act of 1995. Actual events or results may differ materially
from Arena's expectations. Factors that could cause actual results
to differ materially from the forward-looking statements include,
but are not limited to, the following: topline data may not
accurately reflect the complete results of a particular study or
trial; results of clinical trials and other studies are subject to
different interpretations and may not be predictive of future
results; clinical trials and other studies may not proceed at the
time or in the manner expected or at all; the timing and outcome of
research, development and regulatory review is uncertain, and
Arena's drug candidates may not advance in development or be
approved for marketing; enrolling participants in Arena's ongoing
and intended clinical trials is competitive and challenging; the
coronavirus disease (COVID-19) pandemic, including but not limited
to the impact on Arena's clinical operations, the operations of
Arena's suppliers, partners, collaborators, licensees, and capital
markets, which in each case remains uncertain; risks related to
developing and commercializing drugs; Arena will need additional
funds to advance all of its programs, and you and others may not
agree with the manner Arena allocates its resources; the impact of
competition; risks related to unexpected or unfavorable new data;
the risk that regulatory agencies may interpret or weigh the
importance of data differently and reach different conclusions than
Arena or others, request additional information, have additional
recommendations or change their guidance or requirements before or
after approval; satisfactory resolution of litigation or other
disagreements with others; and risks related to the enforcement of
Arena's and third parties' intellectual property rights. Additional
factors that could cause actual results to differ materially from
those stated or implied by Arena's forward-looking statements are
disclosed in Arena's filings with the Securities and Exchange
Commission (SEC), including but not limited to Arena's Annual
Report on Form 10-K for the year ended December 31, 2020, which was
filed with the SEC on February 23, 2021. These forward-looking
statements represent Arena's judgment as of the time of this
release. Arena disclaims any intent or obligation to update these
forward-looking statements, other than as may be required under
applicable law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210302006098/en/
Investors and Media: Patrick Malloy Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate Communications
pmalloy@arenapharm.com 847.987.4878
Arena Pharmaceuticals (NASDAQ:ARNA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Arena Pharmaceuticals (NASDAQ:ARNA)
Historical Stock Chart
From Sep 2023 to Sep 2024