Development ApproachAdamas is developing proprietary medications based on known drugs. Adamas development approach includes identifying novel combinations of known drugs that result in significantly improved clinical benefit, as well as pharmacological characteristics of drugs that impact effectiveness and/or tolerability in specific disease conditions. Adamas then applies its drug development expertise to develop proprietary formulations to achieve the desired target profile. By working with well-characterized and widely studied drug classes, Adamas reduces the uncertainties associated with the development of new chemical entities. Adamas only progresses product candidates to clinical development that possess patentable improvements with demonstrable benefit relative to current standard of care treatments in terms of:
AminoadamantanesAdamas is developing novel pharmaceutical products based on the aminoadamantanes, a known class of drugs that were first synthesized in the 1950s, including amantadine (1-amino-adamantane) and memantine (1-amino, 3,5 dimethyl adamantane). Amantadine was first approved for use in the US in 1966 as a prophylactic agent against Asian influenza and subsequently received approval for the treatment of Influenza A virus in adults. In 1969, the drug was also approved in the treatment of symptoms of Parkinson's disease. The use of amantadine in influenza A is currently not recommended owing to resistance of circulating virus strains to the drug. Amantadine's utility in treating Parkinson's disease symptoms has also declined owing to the arrival of new and more potent dopaminergic agents. However, over the years, amantadine has been reported to have utility in treating other CNS conditions, though the safety and efficacy of amantadine, and an optimal dose and dosing regimen, have never been established in controlled clinical trials for these indications. Adamas is developing novel formulationss/dosage strengths of amantadine which are expected to reduce side effects and improve potency and will explore their utility in the treatment of a range of CNS conditions, including:
Adamas is also developing a new formulation of amantadine as part of a novel triple combination antiviral drug (TCAD) regimen for the treatment of complicated influenza. Memantine, was approved for use in the US in 2003 for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine is an open channel use-activated NMDA receptor ion channel antagonist that is postulated to protect neurons from excitotoxic death. More recently, memantine has been associated with mTor activation, leading to enhanced mood that may explain the symptomatic benefits seen in Alzheimer's disease. Additive benefits have been observed in combination with acetylcholinesterase inhibitors (e.g. donepezil), though the mechanistic basis for this remains unproven. Clinical studies have further shown that memantine/donepezil combination therapy results in significant improvements in cognition and behavior of dementia patients. Memantine's use in combination therapy however is limited by its need for divided dosing and need for titration, both of which are attributable to CNS side effects of the drug. Adamas is developing a fixed dose combination of memantine and donepezil that is designed to improve CNS tolerability, enabling once daily dosing without titration. |