BELLUS Health narrows timelines for the Phase III study for KIACTA™ and reports financial and operating results for the second quarter ended June 30, 2015

LAVAL, QC, Aug. 12, 2015 /CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a drug development company focused on rare diseases, today narrowed timelines for the Phase III Confirmatory Study for KIACTA™ in AA amyloidosis and reported its financial and operating results for the second quarter ended June 30, 2015.

Highlights

  • Approximately 85% of the required events to complete the Phase III Confirmatory Study for KIACTA™ have occurred;
  • KIACTA™ Phase III Confirmatory Study now expected to conclude by the end of the first quarter of 2016, with top-line data expected to be available in the middle of 2016;
  • Concluded the quarter with a cash position of $10.7 million, which should enable the Company to finance its operations beyond the data readout for the KIACTA™ Phase III Confirmatory Study.

 

KIACTA™ for AA amyloidosis - Timelines Update

To date, approximately 85% of the required events to complete the Phase III Confirmatory Study for KIACTA™ have occurred. The KIACTA™ Phase III Confirmatory Study is an event-driven trial that will conclude when 120 patients have experienced an event linked to the deterioration of kidney function. Based on the event rate, the Company anticipates the study will meet the 120 events required to complete the trial by the end of the first quarter of 2016.

Concurrently, management expects that top-line data from the study, which is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis, will be available in the middle of 2016.

"We are excited about our progress with the KIACTA™ program and these narrowed timelines," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We are approximately six months away from study completion, and less than a year away from providing KIACTA™ top-line data."

During the second quarter of 2015, the KIACTA™ Phase III Confirmatory Study continued to progress, following patient enrollment completion in January 2015. A total of 261 patients are participating in the study. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death.

As part of the Phase III Confirmatory Study, there are periodic meetings of the Data Safety Monitoring Board (DSMB), which independently assesses the safety of KIACTA™ throughout the study. Based on its last review in July 2015, the DSMB recommended that the study continue as per protocol.

KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100% of the development costs, including the Phase III Confirmatory Study and other related activities, which total costs are currently estimated to be in excess of US$60 million. Overall proceeds from potential future revenue of KIACTA™ will be shared between Auven Therapeutics and BELLUS Health based on a pre-agreed formula, and assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally.

The process to explore the sale of KIACTA™, which was initiated in May 2014 with the engagement of financial advisor Lazard by Auven Therapeutics, is on-going. This initiative provides increased flexibility to divest KIACTA™ at the most opportune time for stakeholders, whether that is prior to or following the conclusion of the KIACTA™ Phase III Confirmatory Study.

KIACTA™ for Sarcoidosis

BELLUS Health's partner, Auven Therapeutics, is currently developing a Phase II/III clinical study protocol to evaluate the safety and efficacy of KIACTA™ for the treatment of patients suffering from chronic pulmonary sarcoidosis. An investigational new drug application (IND) for this Phase II/III clinical study is expected to be filed with the U.S. Food and Drug Administration by the end of 2015.

All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics. Proceeds from potential future revenue of KIACTA™, including the rights to KIACTA™ for sarcoidosis, are subject to the proceeds sharing agreement between Auven Therapeutics and BELLUS Health.

Chronic sarcoidosis is a rare, potentially fatal inflammatory condition that affects the lungs. There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects.

Shigamab™ for sHUS

Pre-clinical studies are being conducted to evaluate Shigamab™ in the treatment of Hemolytic Uremic Syndrome caused by Shiga toxin-producing E. coli (sHUS). A clinical advisory board meeting will be held in September 2015 to discuss the design of the Phase II clinical study protocol.

During 2014, in studies performed in collaboration with the Uniformed Services University of the United States Department of Defense, Shigamab™ was shown to reduce toxicity of Shiga toxin type 2 in a sHUS mouse model, even following delayed treatment, as measured by body weight loss, renal biomarkers and renal histopathology. These results support BELLUS Health's treatment approach of sHUS.

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.

Summary of Financial Results

All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

  Three months ended June 30, 2015 Three months ended June 30, 2014
  (in thousands of dollars, except per share data)
Revenues 592 420
Research and development expenses (169) (369)
General and administrative expenses (864) (847)
Net finance income - 28
Deferred tax recovery 8 -
Net loss for the period (433) (768)
Net loss attributable to shareholders (426) (737)
Basic and diluted loss per share (0.01) (0.02)

The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three and six-month periods ended June 30, 2015 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

  • Revenues amounted to $592,000 for the three-month period ended June 30, 2015, compared to $420,000 for the corresponding period the previous year. The increase is attributable to higher revenue recognized for accounting purposes in 2015 in relation to the service agreement with Auven Therapeutics for KIACTA™.
  • Research and development expenses amounted to $169,000 for the three-month period ended June 30, 2015, compared to $369,000 for the corresponding period the previous year. The decrease is primarily attributable to lower expenses incurred in relation to the development of Shigamab™ as well as higher research tax credits recognized during the second quarter of 2015 in relation to additional claims for prior years filed during the quarter.

 

As at June 30, 2015, the Company had available cash, cash equivalents and short-term investments totalling $10,682,000, compared to $12,307,000 as at December 31, 2014. Based on management's estimate, the current cash position should enable the Company to finance its operations beyond the data readout for the KIACTA™ Phase III Confirmatory Study, expected in 2016.

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.

About AA Amyloidosis

AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.

There is currently no available treatment for AA amyloidosis. A recent commercial assessment study conducted by Navigant Consulting on behalf of Auven Therapeutics and BELLUS Health identified between 10,000 and 15,000 KIACTA™ eligible patients with AA amyloidosis in the United States and Europe.

KIACTA™ has been granted Orphan Drug designation or its equivalent for the treatment of AA amyloidosis in the United States, Europe and Japan, which provide for market exclusivity for a period of seven to ten years once the drug is approved, as well as a reduction in application and review fees.

Forward-Looking Statements

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
416-815-0700 ext. 225
apeeler@tmxequicom.com


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