- Statistically Significant Improvement on Primary and Secondary Endpoints -
- Cognitive Benefits Support Further Development -
- Company to Host Conference Call Today at 9:00 a.m. EDT -
MONTVALE, N.J., Nov. 2 /PRNewswire-FirstCall/ -- Memory Pharmaceuticals
Corp. (Nasdaq: MEMY) today announced positive top-line data from the
randomized, placebo-controlled, multi-center Phase 2a proof-of-concept trial
of MEM 3454, the Company's lead nicotinic alpha-7 receptor partial agonist, in
80 patients with mild to moderate Alzheimer's disease over an eight week
treatment period. The trial was an exploratory efficacy study to learn about
MEM 3454 as a potential treatment for Alzheimer's disease. The primary
endpoint of the trial was the change from baseline in the Quality of Episodic
Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR)
battery. QESM is a composite score derived from memory tests in the CDR
battery that measure the ability to store, hold and retrieve information.
There were three oral daily doses of MEM 3454 tested in the trial, 5 mg, 15 mg
and 50 mg. The CDR battery was administered at baseline and on six days
during the treatment period, at four time points (pre-dosing and 2, 4 and 8
hours post-dosing) each day. For the eight hour post-dose time points over
the treatment period, subjects receiving 5 mg and 15 mg of MEM 3454
demonstrated a statistically significant effect on the QESM compared to
placebo (p=0.023 and p=0.050, respectively).
Secondary endpoints in the trial included other composite scores from the
CDR battery that measure working memory, attention and executive function, and
the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-Cog). On
secondary CDR battery measures, using all time points combined over the
treatment period, the trial showed that the 5 mg and 15 mg doses achieved
statistically significant positive results on Quality of Working Memory
(p=0.031 and p=0.047). The 15 mg group also demonstrated trends to efficacy
on Speed of Memory (p=0.080). Quality of Working Memory is a composite score
derived from accuracy measures in the CDR battery that reflect how well
subjects can hold information in working memory. The Speed of Memory
composite score reflects the time it takes to recall an item from memory. For
the ADAS-cog, the 15 mg group showed numeric improvements favoring treatment
over placebo. There were two additional secondary endpoints in the study from
the CDR battery, Power of Attention and Continuity of Attention, and on these
measures the study found no statistically significant differences between
treatment and placebo. The 50 mg group also showed no statistically
significant differences favoring treatment at any endpoint in the study.
In analyses of QESM at certain other time points, and for all time points
combined, the placebo group performed statistically significantly better than
the treatment groups due to substantially lower QESM scores at baseline for
the placebo group, at the 2 and 4-hour time points, as compared to the
treatment groups. After adding a covariate for baseline scores to the
statistical model, the MEM 3454 5 mg group demonstrated a statistically
significant change from baseline on QESM at all time points combined compared
to placebo (p=0.032). The MEM 3454 5 mg and 15 mg dose groups demonstrated
statistical significance (p=0.003 and p=0.023, respectively), and the 50 mg
dose group demonstrated a trend favoring treatment (p=0.083) for the eight
hour post-dose time points on QESM. In addition, the 5 mg and 15 mg dose
groups demonstrated a statistically significant effect on Quality of Working
Memory, over all time points combined (p=0.006 and p=0.004, respectively).
The 5 mg dose group also demonstrated a statistically significant effect on
Speed of Memory (p<0.001) over all time points combined.
"Overall, the data from this study demonstrate that MEM 3454 is providing
cognitive benefit and these results are consistent with our previous work with
this compound in volunteers. When an appropriate baseline covariate is
included, the results of this trial are even more robust," stated Keith
Wesnes, Ph.D., the developer of the CDR battery. "It is exciting to improve
the ability of Alzheimer's patients to store and retrieve information from
both working and episodic memory, not only in terms of accuracy but also
speed. These improvements have clinical relevance."
"We believe these trial results provide evidence of MEM 3454's potential
to treat Alzheimer's disease," stated Stephen R. Murray, M.D., Ph.D., Chief
Medical Officer of Memory Pharmaceuticals. "This data is consistent with our
preclinical and Phase 1 results and reinforces our belief that MEM 3454
warrants continued development. We look forward to commencing our Phase 2a
trial of MEM 3454 in cognitive impairment associated with schizophrenia in the
near term."
MEM 3454 was well-tolerated in this trial, with the exception that the
number of subjects with constipation was higher in the treatment groups (43%)
compared to placebo (5%). There was one treatment-emergent serious adverse
event in the 15 mg group, which was deemed not to be treatment-related by the
investigator.
Study Design
The Phase 2a trial was a randomized, double-blind, placebo-controlled
study designed to assess the safety, tolerability and cognitive effects of
three doses of MEM 3454. The trial enrolled 80 subjects with mild to moderate
Alzheimer's disease at five sites in the United States. Subjects in the study
were randomized at enrollment to receive 5 mg, 15 mg or 50 mg of MEM 3454 or
placebo once daily for a period of eight weeks. The primary objective of the
trial was to assess the effect of MEM 3454 using the QESM factor score from
the CDR battery. Secondary objectives included assessing the safety,
tolerability, and pharmacokinetics of MEM 3454 and the drug candidate's effect
on additional psychometric test items from the CDR battery and the ADAS-cog.
Strategic Alliance with Roche for Nicotinic Alpha-7 Receptor Agonists
MEM 3454 is the lead drug candidate being developed by Memory
Pharmaceuticals in connection with its nicotinic alpha-7 receptor agonist
Strategic Alliance Agreement with Roche. Under the terms of this agreement,
Roche has an option to secure a worldwide, exclusive license to develop and
commercialize MEM 3454 upon the fulfillment of certain predefined events,
including among other things the completion of this trial. Roche is obligated
to make a milestone payment to Memory Pharmaceuticals at the time this option
is exercised. In June 2007, Memory Pharmaceuticals expanded its nicotinic
alpha-7 receptor agonist agreement with Roche to support a Phase 2a trial of
MEM 3454 in cognitive impairment associated with schizophrenia. The expanded
agreement provides that Roche would have to make an additional milestone
payment upon completion of the Phase 2a CIAS trial in order to maintain its
license to MEM 3454.
Under this agreement, Memory Pharmaceuticals and Roche actively
collaborate on the discovery and clinical development of additional nicotinic
alpha-7 agonists. Memory Pharmaceuticals is responsible for conducting Phase
1 clinical trials for compounds that emerge from the collaboration, and Roche
is responsible for later-stage development and commercialization. Memory
Pharmaceuticals is currently conducting a Phase 1 program for R4996/MEM 63908,
the second named drug candidate under this agreement.
About MEM 3454
MEM 3454 is a partial agonist of the nicotinic alpha-7 receptor, a highly
specialized receptor found in the CNS. Compounds acting on this receptor
could be beneficial in the treatment of Alzheimer's disease and schizophrenia,
as well as other psychiatric and neurological disorders. Memory
Pharmaceuticals is developing MEM 3454 as potential therapy for Alzheimer's
disease and for cognitive impairment associated with schizophrenia.
Conference Call and Webcast Information
Memory Pharmaceuticals will hold a conference call on Friday, November 2,
2007, at 9:00 a.m. EDT to discuss the top-line data from the trial. The
conference call will also be broadcast live from the "Investors" section of
the Company's website. Memory Pharmaceuticals' senior management will host
the conference call. Investors and other interested parties may access the
call as follows:
Date: Friday, November 2, 2007
Time: 9:00 a.m. EDT
Telephone (U.S.): 800.599.9829
Telephone (international): 617.847.8703
Participant Passcode: 13158706
Webcast: http://www.memorypharma.com
under the "Investors" section
An audio replay of the conference call will be available from 11:30 a.m.
EDT on Friday November 2, 2007, until November 8, 2007. To access the replay,
please dial 888.286.8010 (U.S.) or 617.801.6888 (international) and enter
passcode number 63439591. An audio replay of the conference call will also be
available under the "Investors" section of the Company's website during the
same period.
About the Company
Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on
developing innovative drugs for the treatment of debilitating CNS disorders
such as Alzheimer's disease, schizophrenia, depression and bipolar disorder.
For additional information, please visit our website at www.memorypharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that are subject to
risks and uncertainties. All statements, other than statements of historical
facts, regarding management's expectations, beliefs, goals, plans or Memory
Pharmaceuticals' prospects, future financial position, future revenues and
projected costs should be considered forward-looking. Readers are cautioned
that actual results may differ materially from projections or estimates due to
a variety of important factors, including the outcome of clinical trials of
Memory Pharmaceuticals' drug candidates and whether they demonstrate these
candidates' safety and effectiveness; the risks and uncertainties associated
with: obtaining additional financing to support Memory Pharmaceuticals' R&D
and clinical activities and operations; obtaining regulatory approvals to
conduct clinical trials and to commercialize Memory Pharmaceuticals' drug
candidates; Memory Pharmaceuticals' ability to enter into and maintain
collaborations with third parties for its drug development programs; Memory
Pharmaceuticals' dependence on its collaborations and its license
relationships; achieving milestones under Memory Pharmaceuticals'
collaborations; Memory Pharmaceuticals' dependence on preclinical and clinical
investigators, preclinical and clinical research organizations, manufacturers
and consultants; and protecting the intellectual property developed by or
licensed to Memory Pharmaceuticals. These and other risks are described in
greater detail in Memory Pharmaceuticals' filings with the Securities and
Exchange Commission. Memory Pharmaceuticals may not actually achieve the
goals or plans described in its forward-looking statements, and investors
should not place undue reliance on these statements. Memory Pharmaceuticals
disclaims any intent or obligation to update any forward-looking statements as
a result of developments occurring after the date of this press release.
SOURCE Memory Pharmaceuticals Corp.
-0- 11/02/2007
/CONTACT: Jzaneen Lalani, General Counsel for Memory Pharmaceuticals
Corp., +1-201-802-7249; or Laura Perry of Stern Investor Relations, Inc. for
Memory Pharmaceuticals Corp., +1-212-362-1200/
/Web site: http://www.memorypharma.com /
(MEMY)
CO: Memory Pharmaceuticals Corp.; Roche
ST: New Jersey
IN: MTC HEA
SU: CCA TRI JVN
TY-MJ
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2013 11/02/2007 06:00 EDT http://www.prnewswire.com
