Santarus Announces Presentation of Phase III Data for Rifamycin SV MMX in Travelers’ Diarrhea

Santarus Announces Presentation of Phase III Data for Rifamycin SV MMX in Travelers’ Diarrhea

SAN DIEGO--(BUSINESS WIRE)-- Santarus, Inc. (Nasdaq: SNTS  ) today announced that new data from its Phase III clinical study with the investigational drug rifamycin SV MMX® in patients with travelers’ diarrhea will be featured in a poster presentation at IDWeek in San Francisco at the Moscone Center (Poster Hall C) from 12:30 p.m. to 2:00 p.m. Pacific Time on Saturday, October 5, 2013. The poster (#1306) is titled, Randomized, Double-Blind, Placebo-Controlled Study of Rifamycin SV MMX in the Treatment of Travelers’ Diarrhea. IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).

“The data from this clinical study indicate that rifamycin SV MMX significantly shortened the duration of travelers’ diarrhea and was well tolerated, with adverse events similar to that of placebo in the study. In addition, rifamycin SV MMX demonstrated broad activity, and of interest was the possible activity against invasive pathogens,” said Herbert L. DuPont, M.D., principal investigator and lead author of the poster. Dr. DuPont is Director of the Center for Infectious Diseases and Professor of Infectious Diseases at the University of Texas – Houston School of Public Health, Chief of Internal Medicine at St. Luke’s Hospital and Vice Chairman, Department of Medicine and Clinical Professor at the Baylor College of Medicine.

The company has previously announced that the Phase III study met the primary endpoint of reducing the time to last unformed stool (TLUS) in the intent-to-treat (ITT) population. A summary of the efficacy and safety data from the study is presented below.

                       

Efficacy Results – ITT Population

                               
          Placebo         Rifamycin SV MMX         p-value a
Primary Endpoint - TLUS
TLUS (hours)         68.0         46.0         0.0008
Secondary Endpoint - Treatment Failure
Treatment Failure (% of patients)        

43.1%

        18.6%         <0.0001
 
Other Endpoints
        Placebo       Rifamycin SV MMX       p-value a
Rescue Therapy (% of patients)       24.6%       11.6%       0.01

Diarrheagenic E. colib, n

      37       112      

Clinical cure, %

54.1% 80.4%

0.0035

TLUS (hours), median (95% CI)

     

68.3 (56.4, NC)

      49.3 (42.8, 56.5)        

Invasive Pathogensc, n

11 21

Clinical cure, %

45.5% 81.0%

0.0434

TLUS (hours), median (95% CI)

     

NC (13.6, NC)d

      22.9 (10.2, 53.1)        
 

NC = non-calculable. aSignificance of the difference in distributions of TLUS was assessed using the log-rank test. bIncludes patients with E. coli and no concurrent invasive pathogens. cThe invasive pathogen group includes Shigella spp., C. jejuni, Salmonella spp., Y. enterocolitica, Aeromonas spp., Plesiomonas spp., Vibrio group, G. lamblia, Cryptosporidium spp., Entamoeba spp., and Norovirus. Patients with both Diarrheagenic E.coli and an invasive pathogen at baseline were assigned to the invasive pathogen group. dMedian TLUS could not be calculated because fewer than 50% of patients achieved clinical cure.

           

Adverse Events Experienced by ≥ 2% of Patients in Either Treatment Group

                 
Placebo Rifamycin SV MMX
(N = 65) (N = 199)
Adverse Event      

n (%)

      n (%)
Diarrhea       6 (9.2)       10 (5.0)
Headache       6 (9.2)       17 (8.5)
Infectious diarrhea       5 (7.7)       10 (5.0)
Constipation       1 (1.5)       7 (3.5)
Amoebic dysentery       2 (3.1)       0 (0.0)
Gastrointestinal infection       2 (3.1)       0 (0.0)
 

There were three patients who experienced serious adverse events, all of which were assessed by the investigator as not related to the study drug. One patient in the placebo group developed clostridium difficile colitis and two patients in the rifamycin SV MMX group experienced a total of three adverse events: neuroblastoma, abdominal pain and vomiting.

Santarus licensed rights to develop and commercialize rifamycin SV MMX in the U.S. from Cosmo Technologies Limited. Dr. Falk Pharma GmbH, Cosmo’s European development partner, is conducting a second Phase III clinical study to evaluate the efficacy of rifamycin SV MMX versus ciprofloxacin with the primary endpoint of TLUS in patients with travelers’ diarrhea. This non-inferiority study is expected to enroll approximately 1,000 patients. Assuming positive results in the second Phase III clinical study, Santarus and Dr. Falk plan to share the clinical data from their respective Phase III studies for inclusion in each company’s regulatory submissions.

About the Santarus Rifamycin SV MMX Phase III Clinical Study

The Phase III clinical study conducted by Santarus enrolled 264 adult tourist patients in Mexico and Guatemala, with 199 patients on rifamycin SV MMX and 65 patients on placebo, in a multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of rifamycin SV MMX. The dosing regimen was 400 mg (two oral tablets of 200 mg each) taken twice daily (800 mg total daily dose) of rifamycin SV MMX or placebo for three days in the treatment of patients with travelers’ diarrhea. The primary endpoint of TLUS was defined as the time (hours) between the administration of the first dose of study drug and the time that the last unformed stool was passed before the start of clinical cure. Clinical cure was defined in the study protocol as:

  • The passage of two or fewer soft stools and no watery stools, no fever (>100.4°F or 38°C), and no symptoms of enteric infection (other than mild excess gas/flatulence) during a 24-hour interval in the 120-hour data collection period after the first dose of study drug; or
  • The passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hour data collection period after the first dose of study drug, with or without other signs of symptoms of enteric infection.

Additional information about the Phase III study is available here from clinicaltrials.gov.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products. UCERIS®(budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products is available at www.santarus.com or by contacting Santarus at 1-888-778-0887.

Santarus’ product development pipeline includes the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor). A Biologics License Application for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema is under review by the U.S. Food and Drug Administration with a response expected in April 2014. Santarus is also developing rifamycin SV MMX®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at www.santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus ® , FENOGLIDE ® , UCERIS ® and ZEGERID ® are registered trademarks of Santarus, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET ® is a trademark of VeroScience LLC. MMX ® is a trademark of Cosmo Technologies Limited. RUCONEST ® is a trademark of Pharming Group N.V.



COMPANY:
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
or
Debra P. Crawford, 858-314-5708
Chief Financial Officer
or
INVESTORS:
Westwicke Partners, LLC
Stefan Loren, Ph.D., 858-356-5930
sloren@westwicke.com
or
Robert Uhl, 858-356-5932
robert.uhl@westwicke.com

KEYWORDS:   United States  North America  California

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