On the same day it reported positive Phase Ib data for its lead product, MEM 1003, in Alzheimer's disease, Memory Pharmaceuticals Corp. picked up funds to expand testing of the compound in bipolar disorder.
The Montvale, N.J.-based company entered an agreement with the Stanley Medical Research Institute in Bethesda, Md., to develop MEM 1003, a neuronal L-type calcium channel modulator, as a potential treatment for acute mania in bipolar disorder.
Under the agreement, Memory is eligible to receive a total of $3.2 million in funding, including $960,000 from the sale of 440,367 shares to Stanley at $2.18 per share.
The remaining money would be paid upon the achievement of milestones related to Phase IIa development of the product, said Jzaneen Lalani, vice president of legal affairs for Memory.
A Phase IIa trial of MEM 1003 in bipolar disorder is expected to begin during the first half of 2006.
"The partnership with Stanley is a great way for us to explore MEM 1003 in an indication we have not looked at ourselves," Lalani said, adding that the research institute is "an expert in the area, with solid experience in bipolar disorder."
MEM 1003 is designed to work by "regulating calcium influx abnormalities," she told BioWorld Today, adding that "there's some evidence that calcium dysfunction plays a role in bipolar disorder, so MEM 1003 has the potential to be therapeutic."
If the product is commercialized, Memory will repay funds to SMRI through royalties on future sales of the drug to treat either bipolar disorder or schizophrenia.
Meanwhile, Memory will continue its work on MEM 1003 in the area of Alzheimer's disease. The company has completed Phase I development, including a recently concluded Phase Ib study in AD patients that demonstrated the product's safety and tolerability.
In the first segment of that study, 49 patients received either MEM 1003 or placebo two times daily at escalating doses up to 120 mg per dose, while the second segment administered either 120 mg of MEM 1003 or placebo twice-daily to 32 patients for a period of 10 days. The drug was found to be safe and generally well tolerated, with headaches being the most commonly reported adverse event.
Memory initiated a Phase IIa study to begin evaluating the product's efficacy in AD patients in November, and Lalani said it likely will be completed in early 2007.
"That trial will go concurrently with the Phase IIa trial in bipolar, set to begin early next year and probably completing by the end of 2006," she said.
Along with MEM 1003, Memory is in Phase I development with its nicotinic alpha-7 receptor partial agonist, MEM 3454, and anticipates starting a Phase IIa trial in the first half of next year. That product is aimed at treating schizophrenia.
In October, Memory partnered with Thousand Oaks, Calif.-based Amgen Inc. to develop PDE10 inhibitors for treating certain neurological and psychiatric disorders. In that deal, Memory received a $5 million up-front payment, and could receive milestone payments, as well as up to $5.1 million in research funding over the next two years. Those compounds are in preclinical development. (See BioWorld Today, Oct. 18, 2005.)
The company also is reviewing data from two PDE4 inhibitors it reacquired from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in August after Roche said it was halting further development.
Both MEM 1414 and MEM 1917 were in development for Alzheimer's. (See BioWorld Today, Aug. 22, 2004.)
Lalani said Memory is evaluating data from those drugs to determine if and how to proceed with further development.
The company, which reported a net loss of $11.2 million, or 42 cents per share, for the third quarter, ended September with cash, cash equivalents and marketable securities totaling $47.8 million.
Shares of Memory (NASDAQ:MEMY) closed at $2.12 Tuesday, down 5 cents.