Our approach: ALPHA-1062
A New Approach for the Treatment and Administration of an Alzheimer’s Medication
Current Approaches and Therapeutic Issues
Galantamine, one of only five drugs/combinations approved by the FDA to treat the symptoms of mild to moderate Alzheimer’s disease, has the potential for some patients to delay the need for full time nursing care or institutionalization. However, the currently available oral medications cannot be given immediately to patients at therapeutic doses sufficient for efficacy, and must slowly be titrated up over as many as 6-12 weeks before they can acclimate a patient to the drug (called the “titration stage”). It also causes many patients to experience significant side effects, including nausea, vomiting, and diarrhea. Consequentially, caregivers are challenged by patients taking this medication due to these adverse side effects.
Inventing an Alternative: Alpha-1062
ACI set out to find a better way of treating patients, with a focus that may reduce the side effects experienced by patients. Our experts decided to by-pass the stomach, where current drugs are absorbed, to possibly eliminate the problem. To do this, we needed to invent a new drug that had the attributes of galantamine, but could be formulated into alternative methods, for example via a nasal spray, a dissolvable sub-lingual tablet, or an enteric-coated pill which wouldn’t dissolve until it reached the intestine. Galantamine itself cannot be dosed as a nasal spray for many reasons. Not an easy task.
The ACI Approach: Alpha-1062
Dozens of potential new drugs were created and investigated in several animal studies, until finally one showed the benefits for which scientists were searching. Alpha-1062 is designed as a new generation acetylcholine esterase inhibitor (AChEI) having minimal gastro-intestinal side effects and offering new routes of administration. Alpha-1062 is a patented new chemical entity (NCE) that passes into circulation with little or no side effects, where it then is metabolized into galantamine and can act as a recognized and potent acetylcholine esterase inhibitor. Formulations include tablets and nasal spray device that allow immediate efficacious dosing (no titration), significantly reduced side-effects (which may result in improved adherence/compliance), with statistically significant clinical evidence of improved mental acuity and safety when compared to other approved AChEI therapeutics.
For more information related to the clinical development and results for Alpha-1062, please visit our page: Clinical Pipeline