In the Longevity Drug Race, a U.S. Biotech Claims Age Reversal with Anti-Inflammatory Molecule
In a longevity field fervently pursued by celebrities, tycoons, and venture capital, U.S.-based clinical-stage biotech company BioVie is aiming to disrupt the landscape with a small-molecule anti-inflammatory drug called Bezisterim (NE3107). The drug is being positioned as a potential epigenetic revolution in the fight against aging.
Recently, at the 7th World Aging & Rejuvenation Conference (ARC-2025), Bezisterim became a spotlight feature. According to Phase III clinical trial data presented, patients treated with the compound experienced significant biological age reversal based on multiple epigenetic clock analyses—an average reversal of 3.3 years, with some reaching up to 4.24 years of age reduction.
While reversing biological age using epigenetic clocks is not entirely new, past studies have mostly involved animal models or limited clock algorithms. In contrast, BioVie’s results come from human trials and include analysis using five mainstream epigenetic clocks such as GrimAge and PhenoAge—drawing wider interest.
Bezisterim: From Neuroprotection to Anti-Aging Potential
Bezisterim (also known as NE3107), developed by BioVie, is a synthetic derivative of β-AET. Its core mechanism lies in inhibiting the inflammatory NF-κB pathway and modulating the ERK metabolic pathway, allowing it to reduce chronic inflammation and improve insulin resistance.
These two processes—chronic inflammation and metabolic dysfunction—are central hallmarks in modern theories of aging and age-related diseases (including Alzheimer’s disease). Although the original goal for Bezisterim was neuroprotection in Alzheimer’s, its biological mechanism naturally lends itself to aging intervention.
In a Phase III trial for Alzheimer’s disease (NCT04669028), researchers found not only metabolic and inflammatory improvements but also evidence suggesting biological age reversal.
In total, 33 blood samples from trial participants (17 in treatment group, 16 in placebo) were analyzed using five leading epigenetic clocks. After 30 weeks of treatment, statistically significant age reversals were observed in nearly all clocks:
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Hannum Clock: –4.24 years
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PhenoAge Clock: –4.12 years
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InflammAge Clock: –3.77 years
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SBCAge Clock: –3.16 years
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GrimAge Clock: –1.38 years
Though not a primary endpoint, these findings opened up new possibilities for Bezisterim as a potential anti-aging therapy beyond its original use.
Can 33 Samples Truly Prove Age Reversal?
Despite the headline-grabbing results, the trial data is fragile due to dramatically reduced sample size. The study, detailed in Frontiers in Neuroscience, underwent several complications:
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Initially, 690 patients aged 60–85 were enrolled across 39 U.S. sites.
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After rigorous screening, 439 were randomized into placebo and treatment groups.
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Due to protocol violations at 15 sites and dropouts caused by the COVID-19 pandemic, only 81 subjects qualified for further analysis.
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Of those, just 57 completed treatment and adhered to dosage instructions.
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Due to issues with DNA sample quality and timing, only 33 samples were eligible for epigenetic clock analysis.
This dramatic reduction raises concerns about statistical power and bias. Moreover, since biological age reversal wasn’t a predefined trial endpoint, these findings remain exploratory and cannot yet serve as conclusive evidence.
Still, in a field starved of high-quality human data, even preliminary signals like these offer industry value.
BioVie’s Reality Check: Litigation, Cash Burn & Reverse Splits
Behind the scenes, BioVie faces mounting challenges.
1. Litigation Trouble
Since November 2023, BioVie has been hit with multiple securities fraud lawsuits. Law firms like Rosen Law and Hagens Berman allege clinical trial mismanagement and lack of timely risk disclosure. In March 2025, a court denied BioVie’s motion to dismiss, allowing the case to proceed—further stressing the already financially strained company.
2. Stock Price Collapse
On November 29, 2023, trial issues surfaced, and BioVie’s stock price plunged over 60%, dropping from $4.99 to $1.96 in a single day. Since then, investor confidence has failed to rebound, with shares edging dangerously close to delisting thresholds.
3. Cash Crunch & Reverse Splits
To fund R&D, BioVie raised:
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$21M in March 2024
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$3.2M in October 2024
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$15M+ in November 2024
To avoid Nasdaq delisting, BioVie executed two reverse stock splits:
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1:10 on August 6, 2024
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Another 1:10 on July 7, 2025
These efforts have only barely kept the company afloat, leading to growing doubt about its long-term viability.
Longevity Drug Breakthroughs Remain Distant
Drug development is rarely smooth. While BioVie’s journey has been marred by data inconsistencies and financial instability, its attempts highlight the trial-and-error spirit driving the longevity field forward.
Bezisterim’s “rejuvenation signal” is intriguing—but currently rests on small, contested data. More rigorous trials are needed to establish its true value.
In this uncertain path, cautious optimism is key. Because the next real breakthrough in anti-aging may arise not from hype—but from learning, adapting, and pushing forward through setbacks.
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