Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced first-in-human Phase 1 clinical trial results for CMX157 demonstrating a favorable safety, tolerability and drug distribution profile. In addition, results from a series of preclinical studies showed that CMX157 exhibited highly potent in vitro activity against human immunodeficiency virus (HIV), including HIV strains resistant to current therapies, and potent in vitro activity against xenotropic murine leukemia virus-related virus (XMRV), a blood-borne retrovirus recently associated with chronic fatigue syndrome (CFS).CMX157 clinical and preclinical findings were presented in an oral abstract, titled "CMX157 (HexadecyloxypropylTenofovir), a Clinical Stage Antiretroviral with In Vitro Activity against HIV and XMRV" at the HIV DART™ 2010 Frontiers in Drug Development for Antiretroviral Therapies conference.
"CMX157's promising safety profile and efficient conversion to the active drug in peripheral blood mononuclear cells, coupled with the potent in vitro antiviral activity across diverse drug-resistant strains of HIV, indicate that this compound may directly address the limitations of current HIV therapies," said Randall Lanier, Ph.D., Senior Director of Virology of Chimerix. "We are also excited about CMX157's in vitro antiviral activity against XMRV, a retrovirus recently associated with chronic fatigue syndrome."
"Our CMX001 and CMX157 programs are producing compelling clinical and preclinical evidence of how Chimerix's PIM Conjugate Technology transforms the way compounds are absorbed, distributed, metabolized and excreted, creating new agents with improved antiviral action and reduced toxicities. The promising clinical and preclinical data being reported for CMX157 strengthen our commitment to advancing this novel antiviral for the treatment of HIV and other applications, including its potential to address XMRV associated with chronic fatigue syndrome," said Kenneth I. Moch, President and Chief Executive Officer of Chimerix. "We believe CMX157 holds promise as a highly competitive anti-HIV agent, suitable for combination regimens, with a favorable pharmacokinetic and tolerability profile, and potential for once-weekly dosing. Further, we have intriguing in vitro data showing our PIM Conjugate Technology may facilitate CMX157 access across the blood-brain barrier to address latent retrovirus in compartments that otherwise have proven to be inaccessible by conventional anti-HIV agents. There's a significant need for new HIV therapies to help refractory and inadequately treated patients, and our next step is to evaluate CMX157 in HIV patients."