Memory's phase 1b study of MEM 1003 shows treatment safe, tolerable in Alzheimer's patients

By E. Janene Geiss

Philadelphia, Dec. 20 - Memory Pharmaceuticals Corp. announced Tuesday that preliminary results from its phase 1b U.S. safety and tolerability study demonstrated that MEM 1003 was safe and generally well-tolerated at the dose ranges tested in patients with Alzheimer's disease.

The results also demonstrated that MEM 1003 is cognitively safe in Alzheimer's patients, according to a company news release.

On the basis of the safe profile demonstrated in this study, Memory said it began a phase 2a study with MEM 1003 in Alzheimer's disease in November.

"We were pleased to have achieved the main objective of this study, which confirmed our expectations of the safety profile of MEM 1003. Together with previous clinical and preclinical data, our findings provide a solid rationale for continued development of MEM 1003 as a potential treatment for Alzheimer's disease," David A. Lowe, chief scientific officer, said in the release.

The phase 1b study was conducted under an Investigational New Drug Application from the Food and Drug Administration.

The study consisted of two segments, a double-blind dose-escalation segment and a double-blind multiple-dose treatment segment, officials said.

In the first segment of the study, MEM 1003 or placebo was administered to 49 patients two times on one day.

Patients in this segment of the study were treated at escalating doses that reached 120 milligrams per dose two times per day.

In the double-blind multiple-dose treatment segment, 32 patients received 120 milligrams of MEM 1003 or placebo twice daily for 10 days.

Vital signs such as heart rate, diastolic and systolic blood pressure both supine and standing were measured at various times during each segment of the study.

During the second segment, cognitive function was measured using the Cognitive Drug Research battery and the Alzheimer's Disease Assessment Scale - cognitive subscale.

MEM 1003 was safe and generally well-tolerated up to and including a dose of 120 milligrams two times per day by the patients in the double-blind dose-escalation segment of this study, officials said.

MEM 1003 also was safe and generally well-tolerated by the patients in the double-blind, multiple-dose, 10-day treatment segment. Headache was the most commonly reported adverse event overall.

There were no obvious trends in clinical laboratory safety tests, vital signs or electrocardiogram parameters following treatment. The results also indicated that 10 days of exposure to MEM 1003 did not result in a statistically significant increase or decrease in cognition.

MEM 1003 is a neuronal L-type calcium channel modulator that may have applications in Alzheimer's disease and other diseases associated with cognitive impairment. By blocking L-type calcium channels, MEM 1003 may regulate the flow of calcium and re-establish normal levels of calcium, thereby enhancing cognition and reducing the progression of Alzheimer's disease.

Memory is a Montvale, N.J., biopharmaceutical company focused on developing innovative drugs for the treatment of debilitating CNS disorders such as Alzheimer's disease, schizophrenia, depression, bipolar disorder, vascular dementia, mild cognitive impairment, Parkinson's disease and memory impairments associated with aging.

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