BioAge’s Phase 2 trial to reverse immune aging

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Following compelling animal model data, BGE-175 to be used to treat COVID-19 in older patients by reversing immune aging.

Fresh from announcing a clinical trial targeting unexplained anaemia of aging, longevity biotech company BioAge Labs today announced the initiation of another Phase 2 trial, this time targeting COVID-19. The study will evaluate the efficacy and safety of BGE-175 to treat COVID-19 in patients aged 60 or older. Initial results are expected later this year.

Longevity.Technology: We knew this trial was coming, but it’s still exciting to see how quickly BioAge is moving on two separate clinical fronts. With both BGE-117 and BGE-175 now in Phase 2 trials, the next 12 months may see age-targeting drugs starting to deliver the results of which we all hope they are capable.

Aging is the largest risk factor for COVID-19 morbidity and mortality: people over 80 are hundreds of times more likely to die of the disease than those under 40. Older people are at higher risk in part because the aging immune system becomes less efficient and prone to hyperinflammation. It is thought that rejuvenating the immune system by treating age-related deterioration directly could help to lessen the severity of COVID-19 infection and boost protection by vaccines.

 


 

” … BGE-175 almost completely protects older mice against lethality from infection with SARS-CoV-2, the virus that causes COVID-19 … “

 


 

Through its proprietary platform, BioAge identified the prostaglandin D2 (PGD2) DP1 pathway as a key target for immune aging, and BGE-175 as a potent oral inhibitor of that pathway. BioAge believes that the drug has the potential to counteract immunosenescence and improve aspects of both adaptive and innate immunity.

“By reversing age-related dysregulation of critical immune mechanisms, BGE-175 could allow older patients to more effectively fight off COVID-19,” says BioAge CEO, Kristen Fortney, PhD. “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.”

BioAge CEO, Dr Kristen Fortney

The mouse studies were conducted in collaboration with coronavirus expert Professor Stanley Perlman from the University of Iowa.

“We have shown that BGE-175 can dramatically improve outcomes in mouse models of COVID-19,” says 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.”

BioAge believes that drug’s mechanism could also 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,” says the company’s Chief Medical Officer, Paul Rubin. “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.”

BioAge - reversing aging
BioAge scientists in the lab.

About the BGE-175 trial

The multi-centre, randomised, double-blind, placebo-controlled, parallel-group study is being conducted in the US, Argentina and Brazil, and will recruit 132 patients aged 60 or older, who have been hospitalised for COVID-19 but are not yet in respiratory failure. Previous clinical trials of BGE-175 have demonstrated it to be safe and well-tolerated in more than 2,400 study participants.

The primary endpoint is the proportion of patients who die or progress to respiratory failure. Secondary endpoints include viral load, clinical improvement or worsening, incidence and duration of supplementary oxygen or ventilation, time to discharge or rehospitalisation and intensive care unit admission.

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, providing insight into the drug’s ability to restore normal regulation of the immune system.

Full details are available at ClinicalTrials.gov.

Images courtesy of BioAge Labs
Danny Sullivan
Contributing Editor Danny has worked in technology communications for more than 15 years, spanning Europe and North America. From bionics and lasers to software and pharmaceuticals – and everything in between – he’s covered it all. Danny has wide experience of technology publishing and technical writing and has specific interest in the transfer from idea to market.

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