TEL AVIV, Israel and
RALEIGH, N.C,, Jan. 11, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or "the Company"), a specialty
biopharmaceutical company, today reported that its partner, Cosmo
Pharmaceuticals (SIX: COPN) ("Cosmo"), announced that it had
successfully completed their Phase 2 Proof-of-Concept (POC)
clinical trial of Rifamycin SV-MMX 600mg in patients with
diarrhea-predominant irritable bowel syndrome (IBS-D).
As part of an exclusive license agreement between RedHill and
Cosmo from October 2019 for the U.S.
rights to Aemcolo® (rifamycin), RedHill maintains
certain rights, including a right of first refusal, in relation to
Rifamycin SV-MMX 600 mg in the U.S.
Designed to address the debilitating effects of IBS-D, Rifamycin
SV-MMX is delivered at a 600mg dose and with different release
features to Aemcolo®. Aemcolo® is approved
for travelers' diarrhea (TD) caused by noninvasive strains of
Escherichia coli (E. coli) in adults and
promoted by RedHill for such use in the U.S.
Cosmo reported that results of the Phase 2 POC study show the
achievement of statistical significance in all the study
populations (ITT, FAS, m-FAS and PP) for the composite primary
endpoint (substantial pain and diarrhea decrease) [OR 3.26 (1.39 –
7.67); p-value 0.0066] and for most secondary endpoints such as
adequate relief of IBS-related symptoms [OR 2.18 (1.12 – 4.26);
p-value 0.0227] and IBS-related bloating at the end of treatment
period [OR 2.13 (1.11 – 4.07); p-value 0.0223].
"We are delighted for our partner, Cosmo, on the positive
outcome of this study, which clearly demonstrates the potential for
Rifamycin SV-MMX 600mg, if approved, to be an important treatment
option in tackling IBS-D," said Dror
Ben-Asher, RedHill's CEO.
About Aemcolo® (rifamycin)
Aemcolo® (rifamycin) is an orally-administered,
delayed-release, non-systemic antibiotic approved for the treatment
of travelers' diarrhea caused by non-invasive strains of
Escherichia coli (E. coli) in adults.
Aemcolo® is the first antibiotic engineered with
Cosmo Pharmaceuticals' Multi Matrix Technology (MMX®).
MMX technology is designed to deliver the active pharmaceutical
ingredients in a delayed and controlled manner directly to the
INDICATION AND IMPORTANT SAFETY INFORMATION
Aemcolo® is indicated for the treatment of
travelers' diarrhea caused by noninvasive strains of Escherichia
coli (E. coli) in adults.
Limitations of Use
Aemcolo® is not indicated in patients with
diarrhea complicated by fever or bloody stool or due to pathogens
other than noninvasive strains of E. coli.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of Aemcolo® and other
antibacterial drugs, Aemcolo® should be used only to
treat or prevent infections that are proven or strongly suspected
to be caused by susceptible bacteria.
Aemcolo® is contraindicated in patients with
a known hypersensitivity to rifamycin, any of the other rifamycin
class antimicrobial agents, or any of the
components in Aemcolo®.
WARNINGS AND PRECAUTIONS
Risk of Persistent or Worsening Diarrhea Complicated by Fever
and/or Bloody Stool
Aemcolo® was not shown to be effective in patients
with diarrhea complicated by fever and/or bloody stool or diarrhea
caused by pathogens other than E. coli and is not
recommended for use in such patients.
Discontinue Aemcolo® if diarrhea gets worse or
persists more than 48 hours and consider alternative antibacterial
CDAD has been reported with use of nearly all antibacterial
agents and may range in severity from mild diarrhea to fatal
Consider CDAD in all patients who present with diarrhea
following antibacterial drug use. Careful
medical history is necessary since CDAD has been reported to
occur over two months after the administration of antibacterial
Development of Drug-Resistant Bacteria
Prescribing Aemcolo® in the absence of a proven
or strongly suspected bacterial infection or a prophylactic
indication is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant
Discontinuation of Aemcolo® due to adverse reactions
occurred in 1% of patients. The most frequent adverse reactions
were abdominal pain (0.5%) and pyrexia (0.3%).
Adverse reactions that occurred in at least 2% of
Aemcolo®-treated patients and with a higher incidence
than in the placebo or ciprofloxacin groups were constipation 3.5%
and headache 3.3%, respectively.
USE IN SPECIFIC POPULATIONS
There are no available data on AEMCOLO use in pregnant women to
inform any drug associated risks for major birth defects,
miscarriage, or adverse maternal or fetal outcomes.
There is no information regarding the presence of AEMCOLO in
human milk, the effects on the breastfed infant, or the effects on
The safety and effectiveness of AEMCOLO has not been established
in pediatric patients <18 years of age.
See Full prescribing information
for Aemcolo® is available at www.aemcolo.com
To submit adverse event reports or product complaint reports,
contact RedHill Biopharma, Inc. at
1(833)-ADR-HILL. You are encouraged to report
negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088 (1-800-332-1088).
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs,
Movantik® for opioid-induced constipation in
adults, Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults, and Aemcolo® for
the treatment of travelers' diarrhea in
adults. RedHill's key clinical late-stage
development programs include: (i) RHB-204, with an
ongoing Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) disease; (ii) opaganib (Yeliva®), a
first-in-class SK2 selective inhibitor targeting
multiple indications with a Phase 2/3 program for COVID-19 and
Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing;
(iii) RHB-104, with positive results from a first Phase 3
study for Crohn's disease; (iv) RHB-102
(Bekinda®), with positive results from a Phase 3
study for acute gastroenteritis and gastritis and positive results
from a Phase 2 study for IBS-D; (v) RHB-107
(upamostat), a Phase 2-stage serine protease inhibitor with
a planned Phase 2/3 study in symptomatic COVID-19 and targeting
multiple other cancer and inflammatory gastrointestinal diseases;
and (vi) RHB-106, an encapsulated bowel preparation.
More information about the Company is available at
www.redhillbio.com / https://twitter.com/RedHillBio.
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control and
cannot be predicted or quantified, and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation risks related to the commencement or the timing
of our clinical trials with RHB-102 (Bekinda®) and
ABC294640 (Yeliva®), as well as risks and uncertainties
associated with (i) the initiation, timing, progress and results of
the Company's research, manufacturing, preclinical studies,
clinical trials, and other therapeutic candidate development
efforts, and the timing of the commercial launch of its therapeutic
candidates; (ii) the Company's ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
preclinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
extent and number of additional studies that the Company may be
required to conduct and the Company's receipt of regulatory
approvals for its therapeutic candidates, and the timing of other
regulatory filings, approvals and feedback; (iv) the manufacturing,
clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates and Talicia®; (v)
the Company's ability to successfully commercialize and promote
Talicia®, Aemcolo®, and
Movantik® ; (vi) the Company's
ability to establish and maintain corporate collaborations; (vii)
the Company's ability to acquire products approved for marketing in
the U.S. that achieve commercial success and build its own
marketing and commercialization capabilities; (viii) the
interpretation of the properties and characteristics of the
Company's therapeutic candidates and the results obtained with its
therapeutic candidates in research, preclinical studies or clinical
trials; (ix) the implementation of the Company's business model,
strategic plans for its business and therapeutic candidates; (x)
the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and its ability to operate its business without
infringing the intellectual property rights of others; (xi) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xii) estimates of the
Company's expenses, future revenues, capital requirements and needs
for additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry; and (xv) the hiring and
employment commencement date of executive managers. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on February 26,
2019, as amended on May 15,
2019. All forward-looking statements included in this press
release are made only as of the date of this press release. The
Company assumes no obligation to update any written or oral
forward-looking statement, whether as a result of new information,
future events or otherwise unless required by law.
Chief Corporate &
Business Development Officer
+1 212 529
 Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
 Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
 Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.