BioAge’s ongoing Phase 2 clinical trial is testing the potential of BGE-175 (asapiprant) to decrease mortality in older patients hospitalized with COVID-19

By targeting immune aging rather than the virus, BGE-175 has potential for broad use to treat multiple infections that disproportionately harm the elderly

BioAge Labs, Inc., a biotechnology company developing medications that target the molecular causes of aging to extend healthy human lifespan, today announced that its clinical-stage oral drug BGE-175 (asapiprant), which targets age-related immune deficiencies, protects aged mice from lethal infection with SARS-CoV-2, the virus that causes COVID-19. An article describing the findings was published today in the international scientific journal Nature ^[1].

In the study, daily doses of BGE-175 prevented death in aged mice infected with a lethal dose of SARS-CoV-2. Ninety percent of mice that received the drug survived, whereas all untreated control mice died. BGE-175 treatment was initiated two days after infection, when the mice were already ill, mirroring a situation in which a patient receives medication only after developing symptoms.

In both humans and animals, immune function declines with age, increasing the severity of COVID-19 in people over 65 ^[2–4]. Unlike antivirals currently being investigated to treat COVID-19, BGE-175 corrects these age-related immune deficits rather than targeting the infecting pathogen. The drug acts by inhibiting the PGD2 DP1 protein, which BioAge’s AI-based, human-centric discovery platform has identified as a key target for immune aging. Through this pathway, BGE-175 boosts dendritic cells that help the body identify pathogens and decreases neutrophil infiltration that leads to damaging inflammation, thus combating the decline in immunity that makes older people more vulnerable to infection.

“Our findings clearly show that the therapeutic target of BGE-175 plays a key role in making the aged lung environment conducive for optimal immune function and thereby counters immune aging,” said study author Stanley Perlman, MD, PhD, Professor of Microbiology and Immunology and a Pediatric Infectious Physician at the University of Iowa. “The drug’s protective effect in mice strongly supports the idea that BGE-175 corrects age-related declines in immunity, providing a strong rationale for testing in older patients who are hospitalized with COVID-19.”

A Phase 2 clinical trial ^[5] is underway in the US, Brazil, and Argentina to determine whether BGE-175 can prevent respiratory failure and mortality in patients over 50 years of age hospitalized with COVID-19. The trial was expanded in September 2021 to increase statistical power and better position the company for an emergency use authorization (EUA) application in the event that the trial yields positive results. Top-line data are expected in 2H 2022.

Because BGE-175 targets immune aging rather than a specific pathogen, BioAge is investigating whether the drug could be used to treat respiratory infections other than COVID-19. Pending positive Phase 2 results, the company will continue development for respiratory infections with high morbidity and disproportionate impact on the elderly, such as influenza and viral pneumonia.

“Our team of experts is committed to delivering tools to combat the decline in immunity that leaves older people more vulnerable to infection,” said Kristen Fortney, PhD, CEO of BioAge and an author of the Nature article. “We are encouraged by the study findings and our preclinical data showing BGE-175’s potential to address multiple diseases, including COVID-19, pandemic influenza, and beyond, for which poor outcomes are driven by immune aging.”

Licensing agreements with Shionogi & Co., Ltd., secured in 2021 grant BioAge exclusive rights to develop and market BGE-175 in the US and Europe as a treatment for COVID-19 and the exclusive option to obtain rights for other infectious diseases, including influenza and RSV. Data from multiple Phase 1–3 clinical trials testing the use of BGE-175 for allergic rhinitis demonstrated the drug was safe and well-tolerated in more than 2,400 study participants.

About BioAge

BioAge is a clinical-stage biotechnology company developing a pipeline of treatments to extend healthy lifespan by targeting the molecular causes of aging. The company uses its discovery platform, which combines quantitative analysis of proprietary longitudinal human samples with detailed health records tracking individuals over the lifespan, to map out the key molecular pathways that impact healthy human aging, thus revealing the causes of age-related disease. By targeting the mechanisms of aging with a large and mechanistically diverse portfolio of drugs, BioAge will unlock opportunities to treat or even prevent these diseases in entirely new ways. To date, BioAge has raised $127M from Andreessen Horowitz, Kaiser Foundation Hospitals, and others. BioAge currently has three clinical-stage programs in its growing portfolio. For additional information about BioAge, visit https://www.bioagelabs.com.

References

1. https://www.nature.com/articles/s41586-022-04630-3
2. https://www.nytimes.com/2020/09/08/health/covid-aging-immune-system.html
3. https://thehill.com/opinion/healthcare/498069-covid-19-why-it-kills-the-elderly-and-what-we-should-do-about-it
4. https://www.nature.com/articles/d41586-020-02856-7
5. https://clinicaltrials.gov/ct2/show/NCT04705597

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