VANCOUVER, Dec. 18, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) announced today that its pivotal clinical trial evaluating its lead product candidate davunetide as a treatment for progressive supranuclear palsy (PSP) failed to demonstrate efficacy in this population.
The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale (PSPRS), and the Schwab and England Activities of Daily Living (SEADL). Data analysis failed to detect an effect on either the PSPRS or the SEADL.
The study also examined a series of secondary and exploratory endpoints. There was no evidence of a drug effect on these secondary or exploratory endpoints in the pre-specified analysis. The Company will undertake further analysis to determine if there is any evidence of an effect or explanation for the absence of an effect.
Allon President and CEO Gordon McCauley said, "This is a very sad day for patients, family members, and caregivers living with PSP because so many of them held out great hope that these results would define a drug that has an impact on their disease. Sadly these results have not fulfilled these hopes but we are deeply grateful to them for their unrelenting support of this study. While this outcome is not at all what we anticipated, we do believe that we designed the correct study and executed that study well."
Allon said the multinational phase 2/3 randomized, double-blind, placebo-controlled trial enrolled a total of 313 subjects definitively diagnosed with PSP. Subjects were randomized into two groups, and treated with 30 mg of davunetide or placebo twice per day for 52 weeks. The study was carried out under a Special Protocol Assessment with the United States Food and Drug Administration (FDA) at 47 sites in the United States, Canada, United Kingdom, France, Germany, and Australia. The study was designed to enroll a homogeneous PSP population and data generated by the study confirm this finding.
This study did demonstrate that the study population was highly homogenous and that davunetide is generally safe and well tolerated in this population. The adverse events recorded during the study are typical of this patient population and were generally balanced between the treated and placebo groups.
The Company said it will evaluate its strategic options going forward, but it will not allocate any additional capital to research and development activities for davunetide at this time. This strategic review will include all options for exploiting Allon's assets. Allon undertook the pivotal trial based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
The Company will also take immediate action to reduce its ongoing operating expenses including a reduction in staff.
Allon management will host a conference call to discuss these results today, Tuesday December 18, 2012 at 2:00pm PST/5:00pm EST.
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Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies.
The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
SOURCE Allon Therapeutics Inc.