LAVAL, QC, Sept. 9, 2015 /CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a drug development company focused on rare diseases, today announced that the Company will present data from multiple clinical and pre-clinical studies evaluating BELLUS Health's rare disease drug candidate, Shigamab™, as a potential treatment for shiga-toxin E. coli induced hemolytic uremic syndrome (sHUS).
The data will be presented at the International Symposium on Shiga toxin (verocytotoxin) Producing Escherichia Coli (VTEC) 2015 conference in Boston on September 14-16, 2015.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS, which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.
"The promising data we will share with key opinion leaders attending the conference further validates our therapeutic approach for the treatment of sHUS and reinforces our commitment to develop a new potential treatment for patients affected by this condition," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health.
On Monday, September 14th, at 5:00 pm ET, Eduardo Luis Lopez, MD and Marta Contrini, MD, from the department of Pediatrics Hospital de Ninos "Ricardo Gutierrez", University of Buenos Aires, will deliver an oral presentation titled, `A Phase II Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2 Administered Concomitantly to Children with Shiga Toxin-Producing Escherichia coli Infection and Bloody Diarrhea (SHIGATEC trial)'.
On Tuesday, September, 15th, DJ Stearns-Kurosawa, Ph.D., and Shinichiro Kurosawa, MD, Ph.D., from Boston University School of Medicine, will share a poster presentation titled, `Passive Immunity Strategy for Shiga Toxin-HUS in Non-human Primates'.
On Wednesday, September 16th, at 1:30 pm ET, Alison O'Brien, Ph.D., and Angela Melton-Celsa, Ph.D., from the Uniformed Services University of the Health Sciences Department of Microbiology and Immunology in Bethesda, MD, will deliver an oral presentation titled, 'Chimeric Shiga Toxin Type 2 (Stx2) Antibody (Shigamab™) Rescues Stx2a-Intoxicated Mice from Weight Loss or Kidney Injury When Administered up to 4 Days Post-Intoxication'.
The presentations will be made available on BELLUS Health's website following the conclusion of the conference.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It has a pipeline of rare disease projects including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage Shigamab™ for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics.
sHUS, or shiga-toxin e. coli induced hemolytic uremic syndrome, is a condition that principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children. BELLUS Health estimates that there are approximately 2,000 to 3,000 annual cases of sHUS in developed countries.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS. It has been granted Orphan Drug designation or its equivalent in the United States and Europe, which provides for market exclusivity for a period of seven and 10 years, respectively, once the drug is approved, as well as a reduction in application and review fees.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks factors include but are not limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted clinical trial milestones, dependence on Auven Therapeutics for the completion of the KIACTA™ Phase III Confirmatory Study and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of the KIACTATM Phase III Confirmatory Study is dependent upon many factors, including patient drop-out rate and occurrence of clinical endpoint events, and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ is dependent upon a number of factors, including the quantum of proceeds. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. The Company believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc.'s public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.
For further information: Adam Peeler, National Equicom, 416-586-1941, [email protected]