![](https://www.worldpharmatoday.com/images/nBanners/Docuvera-728x90.jpeg")
BioAge Labs, Inc., a clinical-stage biotechnology company developing medications that target aging to treat severe diseases, announced that it has commenced a Phase 2 clinical trial of BGE-175, a potent oral inhibitor of prostaglandin D2(PGD2) DP1 signaling with a safety database comprising > 2400 patients, for treating COVID-19 patients aged60 or older. Top-line results are expected in 2021
“COVID-19 has devastated elderly populations around the world, largely because the immune system declines with age, making older people much more vulnerable to infection,” said Kristen Fortney, Ph.D., Chief Executive Officer of BioAge. “By reversing age-related dysregulation of critical immune mechanisms, BGE-175 could allow older patients to more effectively fight off COVID-19. Our strongly encouraging preclinical data show that BGE-175 almost completely protects older mice against lethality from infection with SARS-CoV-2, the virus that causes COVID-19. In addition, BGE-175 dramatically decreases viral load in lung tissue, which is correlated with both disease severity and transmission of the virus.
The preclinical data were obtained in collaboration with coronavirus expert Stanley Perlman, MD, Professor of Microbiology and Immunology at the University of Iowa.
”DP1 signaling becomes dysregulated with aging and adversely affects the immune response of older animals to SARS-CoV-2 and other viral challenges. We have shown that BGE-175 can dramatically improve outcomes in mouse models of COVID-19,” said Dr. Perlman. “Because some of the rapidly spreading variants of SARS-CoV-2 are vaccine-resistant, it is critically important to develop COVID-19 treatments, like BGE-175, that are likely to be equally effective against infections with these more contagious and potentially more lethal strains.”
About the Phase 2 trial
The randomized, placebo-controlled, parallel-group, multicenter, double-blind study will recruit patients ≥ 60 years old hospitalized for COVID-19 who are not yet in respiratory failure. A total of 132 participants will receive daily doses of BGE-175 or placebo(66 in each group) for up to 14 days. The study medication will be administered orally or, in patients who cannot swallow, via nasogastric tube. The trial is being conducted in the US, Argentina, and Brazil.
The primary endpoint is the proportion of patients who die or progress to respiratory failurewithin28 days after receiving the first dose of BGE-175. Secondary endpoints include viral load, clinical improvement or worsening, incidence and duration of supplementary oxygen or ventilation, time to discharge or rehospitalization, and intensive care unit (ICU) admission, all over a 57-day period after the first dose. The study will also measure PGD2DP1 signaling activity and the levels of inflammatory markers. Full details of the trial are available at ClinicalTrials.gov.
Some cases of COVID-19 are associated with uncontrolled inflammation, which increases disease severity and morbidity. Hence, the trial will also measure BGE-175’s effect on levels of inflammatory markers, including cytokines, CD4+ and CD8+ T cells, and total lymphocytes. The resultant data will provide insight into BGE-175’s ability to restore normal regulation of the immune system.The drug’s mechanism could be useful against diseases beyond COVID-19.
“By targeting immune aging directly, BGE-175 has the potential to boost immune cell function while preventing dangerous overreaction.” said Paul Rubin, M.D., Chief Medical Officer of BioAge. “PGD2 DP1 signaling is associated with increased susceptibility to infection and risk of mortality. A correlation between inhibition of PGD2 DP1 and patient response in this trial would provide evidence that BGE-175 has the potential to reverse age-related decline in immune mechanisms that are critical for host defense against major viral challenges such as COVID-19, SARS, and pandemic influenza.
About BioAge
BioAge is a biotechnology company that develops proprietary drugs to treat aging and aging-related diseases. Since its founding in 2015, the Company has raised more than $127 million in venture capital funding from Andreessen Horowitz, Kaiser Foundation Hospitals, Khosla Ventures, Felicis Ventures, and others to back its AI-driven approach of mapping the molecular pathways that impact human longevity. BioAge’s mission is to develop a pipeline of therapeutic assets that target aging to treat severe diseases.
