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news.MethylGene, a clinical stage, biopharmaceutical company, has announced the administration of MGCD290 as a single agent to the first cohort of healthy adult volunteers in a Phase I clinical study. MGCD290 is an orally available fungal Hos2 inhibitor designed to be used in combination with azoles for the treatment of fungal infections.
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This double-blind, placebo-controlled Phase I study (Study 290-001), is expected to enroll up to 60 adult healthy volunteers. MGCD290 will be administered orally at an initial starting dose of 100mg and dosing levels will increase with each new cohort. The purpose of this trial is to evaluate MGCD290’s safety, pharmacokinetics and tolerability.
In preclinical studies performed by key antifungal experts, the combination of MGCD290 with azoles increased the potency of the azole and expanded its antifungal spectrum of activity. In particular, the combination of MGCD290 and fluconazole broadened the spectrum of azole activity in vitro and increased fungal sensitivity to fluconazole in vitro and in vivo, including fluconazole-resistant clinical isolates.
Donald Corcoran, president and CEO of MethylGene, said: “Our goal is to complete single and multiple dosing in this study followed by combination studies of MGCD290 and fluconazole in healthy volunteers. In addition, we will evaluate potential partnering opportunities and funding requirements prior to advancing MGCD290 into Phase II trials.”