A 2-part trial shows a new antibody that suppresses HIV when combined with antiretroviral therapy (ART).
PRO 140, a novel humanized CCR5 monoclonal antibody, can be an effective long-term treatment for patients infected with HIV-1 who were previously treated when combined with antiretroviral therapy (ART), according to trial results presented at the annual meeting of the American Society for Microbiology, ASM Microbe.
The trial found that 1 subcutaneous injection of PRO 140, when combined with ART, resulted in a viral load reduction of 97% from the mean baseline.
CytoDyn Inc. developed PRO 140 to advance the treatment of patients with HIV-1, according to the presentation at ASM Microbe, which was held from June 7-11 in Atlanta, GA.
"While ART has greatly advanced over the years, new agents are needed to improve the potency and pharmacokinetic profiles, decrease toxicity, combat drug resistance, and improve convenience to facilitate patient compliance," Nader Pourhassan, PhD, President and CEO of Cytodyn, said in a press release. "These trial results support the continued development of PRO 140 as a simple-to-administer, long-acting HIV-1 therapy that, together with optimized background ART, can provide a valuable new therapeutic option for patients who have become resistant to multi-antiretroviral agents."
For the study, patients were randomly divided into 2 groups for the first 1-week portion of the trial, with both groups remaining on ART. The trial included 50 patients with proven HIV-1 replication who were currently undergoing ART and have previously shown resistance to at least 2 antiretroviral drugs.
One group received a single 350-mg subcutaneous injection of PRO 140, while the other group received a placebo injection. After the first treatment period, the first part of trial met the primary endpoint of a proportion of patients with viral load reduction of ≥0.5 log10 in HIV-1 RNA from the baseline, according to the findings.
All patients knowingly received a weekly subcutaneous injection of PRO 140 in conjunction with ART for 24 weeks following the first arm.
According to the press release, the researchers are working on the addition of PRO 140 to ART as a widespread method of viral suppression in HIV-1
"With the highly favorable efficacy results for this combination therapy trial, and data from our previous trials and our ongoing monotherapy trial, we are now working toward the filing of a Biological License Application, or BLA, with the FDA for PRO 140 in the combination therapy indication," Dr Pourhassan concluded.
Weekly injections of PRO 140 in combination with optimized ART shows HIV-1 viral suppression [news release]. ASM’s website. https://www.asm.org/index.php/2-uncategorised/95949-weekly-injections-of-cytodyn-s-pro-140-in-combination-with-optimized-antiretroviral-treatment-shows-long-acting-hiv-1-viral-suppression. Accessed June 13, 2018.