Mithridion, Inc, a biopharmaceutical company focusing on serious central nervous system (CNS) disorders, announced results from a phase-I pharmacokinetic and clinical study of MCD-386, its lead drug candidate for Alzheimer's disease (AD). MCD-386 is an M1 selective muscarinic agonist with 'first-in-class' potential for improving memory and cognition symptoms, and for disease-modifying effects (or stopping disease progression) in AD.
Mithridion is developing a controlled release formulation with the dual objectives of extending the duration of action and avoiding elevated peak (Cmax) concentrations, while maintaining the MCD-386 concentration above the therapeutic level. The company plans to evaluate the safety, tolerability and pharmacokinetics of MCD-386 in a randomized, double-blind, placebo-controlled, ascending multiple-dose Phase I study to commence in the fourth quarter of 2009.
Trevor M Twose, chief executive officer of Mithridion, commented on the results, "We are very encouraged that we fully met our objectives for this study, and are confident that the combination of the good selectivity for M1-muscarinic action seen in preclinical testing and a controlled release formulation will provide the desired therapeutic action and good safety profile for a first-in-class therapeutic. In addition to MCD-386, Mithridion is developing a pipeline of products for CNS disorders."
James Vanderlugt, medical director of the Jasper Clinic, commented, "The study reached the decision endpoints in an efficient time schedule. We are encouraged that the pharmacokinetic profile demonstrated in this phase-I study supports formulation development for further clinical studies of multiple doses."
In preclinical tests, MCD-386 selectively activated M1-type muscarinic receptors, while maintaining a low level of M3 activity. This differentiation is important because M3 receptor activation is known to cause sweating, salivation and other unwanted side effects.
Mithridion is a biopharmaceutical company that discovers and develops drugs for central nervous system (CNS) disorders, with an initial focus on Alzheimer's disease and schizophrenia.
Jasper Clinic is an independent clinical research organization that performs research studies for all the major pharmaceutical organizations.