ChemDiv has reached a development milestone in partnership with Viriom Inc. by advancing its lead HIV drug candidate, Elpida®, to Phase IIb comparator study with Efavirenz (EFV). Viriom presented the results of the study at the Conference on Retroviruses and Opportunistic Infections (CROI 2017) in Seattle, WA.
In this Phase IIb randomized, placebo-controlled, double-blind, multicenter study ART-naïve HIV-1-infected patients were treated for 48 weeks. A total of 120 patients were randomized 1:1 to receive: 1) Elpida 20 mg QD, or 2) EFV 600 mg QD. All patients were treated with TDF/FTC.
This study demonstrated equivalent virologic and immunologic efficacy of ART regimens including Elpida and those including EFV in ART-naive HIV-1 infected patients. A total of 91.7% Elpida and 78.3% EFV patients completed treatment. Significantly fewer adverse events, including CNS and skin disorders, were observed with Elpida. The ART regimens incorporating Elpida were significantly better tolerated than EFV-based therapy.
“We are very excited by these results. Elpida offers a safer alternative to EFV-based ART,” commented Dr. Vadim Bichko, Viriom’s Chief Scientific Officer. “We are also very pleased with the work of our partners at ChemDiv. ChemDiv’s profound expertise in medicinal chemistry and small molecule drug optimization was instrumental in the rapid advancement of this program.”
“This milestone with Viriom is a good opportunity for us to showcase our proprietary technologies and high-level of expertise in drug discovery and development,” added Ron Demuth, Senior Vice President of Corporate Development at ChemDiv. “Our collaboration also involves working with other innovative antiviral drugs and drug combinations in Viriom’s pipeline, such as PrEP, PEP, long-acting injectable and fixed-dose formulations. We look forward to working with Viriom to advance HIV treatment alternatives to patients worldwide.”
Viriom is an emerging leader in the development of innovative antiviral drugs and drug combinations, as well as treatment and diagnosis methods. Viriom’s most advanced drug is Elpida/elsulfavirine, a once-daily oral prodrug of VM-1500A, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). Viriom expects to obtain first market registration for Elpida in 2017. Development is underway for once-weekly oral and longer-acting parenteral formulations of Elpida/elsulfavirine, as well as drug combination formulations. Learn more http://viriom.com/
ChemDiv is a recognized global leader in discovery chemistry with one of the industry’s largest, most diverse, and most productive collections of over 1,600,000 individually crafted, lead-like, drug-like small molecules. Over the past 25 years the ChemDiv team has delivered hundreds of leads, drug candidates and new drug approvals in the areas of CNS, oncology, virology, inflammation, cardio and metabolic diseases to its pharma and biotech customers around the globe. ChemDiv’s integrated drug discovery and evaluation platforms allow for an accelerated, cost-effective R&D process aimed at rapidly bringing a project from target ID to Phase 3 clinical candidate and beyond. Learn more at http://www.chemdiv.com/, discover ChemDiv’s antiviral libraries here.