RedHill's Partner Cosmo Pharmaceuticals Successfully Completes Phase 2 Study of Rifamycin SV-MMX 600mg in IBS-D
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).Â
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 lower intestine.
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.
CONTRAINDICATION
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 therapy.
Clostridium difficile-Associated Diarrhea (CDAD)
CDAD has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.
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 agents.
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 bacteria.
ADVERSE REACTIONS
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
Pregnancy
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.
Lactation
There is no information regarding the presence of AEMCOLO in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric Use
The safety and effectiveness of AEMCOLO has not been established in pediatric patients
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.