Mithridion, a biopharmaceutical company, has announced encouraging results from a Phase I pharmacokinetic and clinical study of MCD-386, its lead drug candidate for Alzheimer’s disease.
The Phase I study was a randomized, double-blind, placebo-controlled, ascending single dose trial conducted in 24 healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of MCD-386. Serum drug concentrations were successfully measured in the 18 subjects receiving MCD-386; enabling pharmacokinetic parameters to be determined.
According to Mithridion, MCD-386 was rapidly absorbed, reaching maximum serum concentrations in one hour to 1.5 hours, and serum concentrations were linearly related to dose. The mean serum half-life was approximately 1.4 hours. MCD-386 was well tolerated at low doses with no adverse drug related events reported.
Mithridion is developing a controlled release formulation with the dual objectives of extending the duration of action and avoiding elevated peak 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 Twose, CEO of Mithridion, said: 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.