- Asclepios Bioresearch to fund Phase IIa study in Alzheimer's disease -
LAVAL, QC, Sept. 4, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today announced that it has entered into a partnership with Asclepios Bioresearch (UK) Limited ("Asclepios") for the clinical development of BLU8499 (formerly named NRM8499), BELLUS Health's drug candidate for the treatment of Alzheimer's disease. Under the terms of the agreement, Asclepios will fund all Phase IIa enabling activities immediately and has committed to a second tranche of additional capital for the conduct of a Phase IIa clinical trial in mild Alzheimer's disease patients. The total investment and commitment by Asclepios towards the development of BLU8499 is at least US $4 million.
"We are very happy to be working with Asclepios Bioresearch to pursue the development of BLU8499 into a proof of concept study," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "This collaboration allows us to use non-dilutive capital while retaining significant upside for our shareholders."
"Alzheimer's is a devastating disease that affects both patients and their families," said Simon Conder, Director of Asclepios. "We are excited to partner with the team at BELLUS Health to advance BLU8499 into a Phase IIa study and hope that this compound will make a difference in the lives of those affected by this condition."
The Phase IIa study is expected to be initiated in the second half of 2013. The trial will focus exclusively on Alzheimer's disease patients with an apoE4 positive genotype, which is the subgroup where the greatest level of treatment effect was seen in a previous Phase III study conducted with tramiprosate, the parent compound of BLU8499.
BELLUS Health will form a joint steering committee with Asclepios to oversee the program's development efforts. Under the terms of the agreement, BELLUS Health will earn study management fees equal to 15% of the capital invested by Asclepios over the life of the partnership. According to the agreement, it is expected that the two parties will share the overall proceeds from the future monetization of BLU8499 approximately equally.
Formerly named NRM8499, BLU8499 is a prodrug of tramiprosate, a candidate for the treatment of Alzheimer's disease. In January 2011, BELLUS Health announced the results of the phase I clinical trial for BLU8499, which investigated the safety, tolerability and pharmacokinetic profile of BLU8499 as compared to tramiprosate in a group of 67 young and elderly healthy subjects. The phase I clinical trial data demonstrated that BLU8499 was safe and well tolerated at the intended therapeutic dose. Moreover, the gastrointestinal tolerability and pharmacokinetic profile of tramiprosate were meaningfully improved with BLU8499.
About Asclepios Bioresearch (www.abioresearch.com)
Asclepios Bioresearch, a life sciences company based in the city of London (UK), provides private equity, pharmaceutical advisory and capital raising services for early-mid stage pharmaceutical candidates, medical devices and diagnostic technologies. Asclepios Bioresearch's multi-talented team is driven by the objective to increase the value of meaningful and credible technologies that advance human science. Since its inception in October 2009, Asclepios Bioresearch has successfully fundraised in excess of $100 million to advance trials for a number of clinical-stage candidates for Alzheimer's disease, Type 2 Diabetes and chronic wound healing.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. KIACTA™, the Company's lead program, is a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics Inc. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.
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. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the ability to obtain financing immediately in current markets, the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Company's public fillings including the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the Company and its business.
SOURCE: BELLUS HEALTH INC.
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