MEMY » Topics » MEM 1414 for the treatment of Alzheimers disease

These excerpts taken from the MEMY 10-K filed Mar 28, 2008.
MEM 1414 for the treatment of Alzheimer’s disease
 
In preclinical tests of cognition in several species, MEM 1414 reversed memory deficits and demonstrated significant and sustained improvements in cognitive function over a wide dose range. Furthermore, after a single dose applied to a rat model, positive effects on long-term memory were sustained over a three-month period.
 
In February 2005, Roche completed a Phase 1 clinical trial program for MEM 1414. The Phase 1 program consisted of four trials: a double blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of MEM 1414, in which 32 volunteers received MEM 1414; a bioequivalence study, in which 15 volunteers received MEM 1414; a scopolamine challenge study, in which 38 volunteers received MEM 1414, and a MAD study, in which 40 healthy elderly volunteers received MEM 1414 for 14 days. At all doses tested in this Phase 1 clinical trial program, MEM 1414 was generally safe and well tolerated.
 
We plan to progress MEM 1414 into a Phase 2a clinical trial by the end of 2008, either on our own or with a collaboration partner.
 
MEM 1414
for the treatment of Alzheimer’s disease



 



In preclinical tests of cognition in several species, MEM 1414
reversed memory deficits and demonstrated significant and
sustained improvements in cognitive function over a wide dose
range. Furthermore, after a single dose applied to a rat model,
positive effects on long-term memory were sustained over a
three-month period.


 



In February 2005, Roche completed a Phase 1 clinical trial
program for MEM 1414. The Phase 1 program consisted of four
trials: a double blind, placebo-controlled study to evaluate the
safety, tolerability and pharmacokinetics of single ascending
doses of MEM 1414, in which 32 volunteers received MEM 1414; a
bioequivalence study, in which 15 volunteers received MEM 1414;
a scopolamine challenge study, in which 38 volunteers received
MEM 1414, and a MAD study, in which 40 healthy elderly
volunteers received MEM 1414 for 14 days. At all doses
tested in this Phase 1 clinical trial program, MEM 1414 was
generally safe and well tolerated.


 



We plan to progress MEM 1414 into a Phase 2a clinical trial by
the end of 2008, either on our own or with a collaboration
partner.


 




This excerpt taken from the MEMY 10-K filed Apr 2, 2007.

MEM 1414 for the treatment of Alzheimer’s disease

In preclinical tests of cognition in several species, MEM 1414 reversed memory deficits and demonstrated significant and sustained improvements in cognitive function over a wide dose range. Furthermore, after a single dose applied to a rat model, positive effects on long-term memory were sustained over a three-month period.

In February 2005, Roche completed a Phase 1 clinical trial program for MEM 1414. The Phase 1 program consisted of four trials: a double blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of MEM 1414, in which 32 volunteers received MEM 1414; a bioequivalence study, in which 15 volunteers received MEM 1414; a scopolamine challenge study, in which 38 volunteers received MEM 1414, and a MAD study, in which 40 healthy elderly volunteers received MEM 1414 for 14 days. At all doses tested in this Phase 1 clinical trial program, MEM 1414 was safe and generally well tolerated. There were no clinically significant abnormal laboratory findings and there were no serious adverse events reported in the SAD study that were attributable to the drug. The pharmacokinetics of MEM 1414 were linear at the dose ranges tested and the drug was rapidly absorbed after oral administration. Food and age had no significant effect on the bioavailability of MEM 1414. A total of 31 volunteers in the MAD study reported adverse events and these were randomly distributed among each of the dose groups and the placebo groups. The majority of the events were mild and only a few were classified as moderate in intensity. None of the reported moderate adverse events required treatment or dose adjustment and there were no subject withdrawals during the MAD study.

In April 2005, Roche decided not to pursue further clinical development of the two named compounds under our 2002 Roche Agreement, MEM 1414 and its back-up candidate, MEM 1917. In August 2005, we reacquired the rights to MEM 1414 from Roche. We have evaluated the data that we received from Roche and are currently exploring the potential for a new collaboration for MEM 1414. Any further development of MEM 1414 will be funded largely through such a collaboration. We cannot assure you that we will be successful in securing a new collaboration partner for MEM 1414 or that we will continue its development on our own.

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