MEMY » Topics » PDE4 Inhibitor Program: MEM 1414 and MEM 1917

These excerpts taken from the MEMY 10-K filed Mar 28, 2008.
PDE4 Inhibitor Program: MEM 1414 and MEM 1917
 
PDE4 inhibitors are designed to inhibit the activity of PDE4, an enzyme which breaks down neuronal cAMP. PDE4 inhibitors may have therapeutic utility in multiple indications, including, Alzheimer’s disease, schizophrenia, respiratory disease and drug abuse. In June 2007, in conjunction with an amendment to our Amended and Restated 2003 Roche Nicotinic Alpha-7 Agonist Agreement, we reacquired all development and commercialization rights to the PDE4 inhibitor program.
 
We have evaluated the data that we received from Roche and are currently evaluating alternatives for the further development of this program, which could include taking the program forward, in whole or in part, on our own or with a new collaboration partner.
 
PDE4
Inhibitor Program: MEM 1414 and MEM 1917



 



PDE4 inhibitors are designed to inhibit the activity of PDE4, an
enzyme which breaks down neuronal cAMP. PDE4 inhibitors may have
therapeutic utility in multiple indications, including,
Alzheimer’s disease, schizophrenia, respiratory disease and
drug abuse. In June 2007, in conjunction with an amendment to
our Amended and Restated 2003 Roche Nicotinic Alpha-7 Agonist
Agreement, we reacquired all development and commercialization
rights to the PDE4 inhibitor program.


 



We have evaluated the data that we received from Roche and are
currently evaluating alternatives for the further development of
this program, which could include taking the program forward, in
whole or in part, on our own or with a new collaboration partner.


 




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

PDE4 Inhibitor Program: MEM 1414 and MEM 1917

Alzheimer’s disease

PDE4 inhibitors are designed to inhibit the activity of PDE4, the enzyme which breaks down neuronal cAMP. Studies have shown that administering PDE4 inhibitors can have a restorative effect on memory loss in animal models, including those of Alzheimer’s disease. Based on these findings, in addition to our own research on the neuronal pathways involved in Alzheimer’s disease, we believe that we may be able to treat this disease by increasing the levels of neuronal cAMP.

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.

MEM 1917 for the treatment of Alzheimer’s disease and depression

MEM 1917 is a PDE4 inhibitor and a back-up candidate to MEM 1414 for the treatment of Alzheimer’s disease. As is the case with MEM 1414, MEM 1917 is designed to inhibit the activity of PDE4, the enzyme that breaks down neuronal cAMP.

 

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MEM 1917 is also a potential candidate for the treatment of depression. We believe that the pathways involved in memory formation may also be implicated in depression, although this link is not fully established or understood. If there are shared pathways in memory formation and depression, increasing levels of cAMP by inhibiting the action of PDE4 may remediate the neuronal imbalances and the cognitive impairments that occur in depressed patients.

In multiple animal behavior models of cognitive impairment, MEM 1917 has reversed memory deficits. In addition, in several animal models of depression, MEM 1917 has demonstrated efficacy in both short-term and long-term tests of antidepressant activity.

In August 2005, we reacquired the rights to MEM 1917 from Roche, following Roche’s earlier decision not to pursue the clinical development of this drug candidate. We have evaluated the data that we received from Roche and are currently exploring the potential for a new collaboration for MEM 1917. Any further development of MEM 1917 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 1917 or that we will continue its development on our own.

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