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.
Participant Local Dial-in Number(s): 647-427-7450
Participant North American Toll Free Number: 1-888-231-8191
Encore Toll Free Dial-in Number: 1.855.859.2056
Encore Local Dial-in Numbers: 403.451.9481
Encore Password: 83111462
The conference call will be archived for replay for 1 week
Allon Therapeutics Inc. is a clinical-stage biotechnology company
focused on bringing to market innovative central nervous system
The Company is listed on the Toronto Stock Exchange under the trading
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.
Allon Therapeutics Inc.
SOURCE Allon Therapeutics Inc.