Springboard-Supported Start-Up Announces Positive 1A Outcome For Alzheimer’s Drug
September 26th, 2014
Neurodyn Life Sciences Inc. announced completion of its first-in-human clinical study, demonstrating Memogain’s potential benefits over existing Alzheimer’s drugs; increased safety in the absence of significant side effects, more potent cognitive enhancement.
The Phase IA clinical trial addressed safety, tolerability, and pharmacokinetics of intranasally delivered Memogain® in healthy young and elderly subjects, compared to the daily recommended doses of the current Alzheimer’s drugs: galantamine (16 mg) and donepezil (10 mg). Study participants were additionally tested for improved cognition.
The administration of Memogain® was found to be safe and well tolerated at all dose levels. No clinical abnormalities were seen in hematology, blood chemistry, urine analysis, ECG or vital signs. Adverse events were either mild or moderate. The most prevalent being nausea, reported by a few subjects administered the standard galantamine dose of 16 mg, but only observed at the highest Memogain® dose (44mg). The excellent safety and tolerability of Memogain®, will dispense with the month-long gradual dosage increase that presently is common practice for other Alzheimer’s drugs, permitting the immediate administration of an efficacious dose.
“This outstanding safety and tolerability profile is achieved even though Memogain®, a prodrug of galantamine, has a 10 times higher concentration in the brain, as compared to orally administered galantamine” says Dr. Maelicke, Memogain’s developer. “Additionally, Memogain® has a delayed release profile which could facilitate single daily dosing.”
In cognitive testing, Memogain® was able to improve vigilance and short-term memory capacity: eye-hand coordination and vigilance was measured in the adaptive tracking test, and word learning and recall in the visual verbal learning test (VVLT). Both young and elderly subjects performed better than untreated volunteers in these tests. Galantamine, failed to show improvement in either the adaptive tracking test, or the VVLT, where donepezil also failed to demonstrate improvement.
Earlier preclinical studies have demonstrated Memogain’s potential to provide neuroprotection and delay disease progression. Should future clinical studies also substantiate these findings, Memogain® may become the urgently needed turning point in the treatment of Alzheimer’s and other neurodegenerative diseases such as Parkinson’s disease.
About Memogain (GLN-1062): Memogain is a patent-protected synthetic derivative of the natural cognitive enhancer galantamine, which is currently used for the treatment of mild to moderate Alzheimer’s disease. Memogain is, an inactive form of galantamine that has more than a 10 fold higher preference for the brain than native galantamine. Once in the brain, the Memogain delivery vehicle is in effect ‘stripped off’ to reveal the active drug galantamine. In this way Memogain is able to produce much higher brain levels of galantamine than can be achieved by the current oral administration. The Phase 1A results have demonstrated that Memogain’s design promotes higher preference for the brain, and thus fewer adverse side effects while at the same time providing higher cogitative enhancement, compared to presently marketed Alzheimer’s drugs.
About Neurodyn: Neurodyn Inc. (www.neurodyn.ca) is a Canadian biotechnology company focused on identifying, validating and developing natural compounds into both prescription drugs and natural products for the early treatment of neurological diseases.
Contact information:
Kenneth Cawkell, CEO; kcawkell@neurodyn.ca, +1 604 619 0990
Dr. Alfred Maelicke, Managing Director Europe; alfred.maelicke@neurodyn.eu
Dr. Denis Kay, CSO; dgkay@neurodyn.ca, +1 902 314 0776
Robert Cervelli, Executive Director; cervelli@neurodyn.ca, +1 902 222 4391