BNAD101: Oral solid dose NAD+ therapeutic clinically proven to rapidly increase intracellular NAD
A novel approach in neuropharmacology, specifically developed to address the multifaceted nature of neurological diseases
Bryleos is a woman-owned and women-led company dedicated to making significant advancements in the treatment of multifactorial neurological diseases. Moving beyond traditional single-target drug models, BNAD101 is engineered to modulate a circumscribed set of pathways with a known role in the pathogenesis of neurodegenerative diseases. The dysregulation of these pathways is common across different neurodegenerative diseases (in particular ALS, PD, MS, SUD) and highlights the fundamental link between impaired cellular metabolism and neuroinflammation.
Lead asset, BNAD101, increases intracellular NAD
In 2022, Bryleos reached a pivotal milestone, completing a randomized study in partnership with the Institute of Systems Biology. Our key compound, BNAD101, achieved a 52% increase in intracellular NAD levels compared to placebo, showing potential in modifying pathways linked to neurodegenerative diseases. BNAD101 targets crucial factors including oxidative stress, mitochondrial dysfunction, and the regulation of glutamate to avert neurotoxicity.
What is NAD?
NAD is a pivotal molecule governing crucial aspects such as mitochondrial function, oxidative stress, enzyme activity, DNA repair, inflammation, and a multitude of costly chronic diseases. For over a century, the immense potential of NAD+ has remained untapped in therapeutics. This is primarily due to its inherent chemical instability, rapid degradation in the gut, and limited bioavailability.
Why NAD Matters
NAD is found in every cell in the human body and is essential for creating cellular energy and maintaining healthy cell function. NAD declines with age and is a central factor in the aging process. Depletion of NAD levels is a key feature in multiple chronic diseases, especially those related to oxidative stress, mitochondrial dysfunction and glutamate toxicity.
Current approaches to increasing NAD have limitations
NAD precursors NR and NMN are designed to increase NAD levels over time
- High interindividual variability in conversion rate
- Delayed onset of therapeutic effect
- Limited role in pharmacotherapeutics
- More applicable to optimizing wellness vs treating disease
IV NAD+, while fast-acting, is not practical or scalable
- Chemically unstable
- Made at a compounding pharmacy
- No IP – lack of clinical studies means it will never become the standard of care
- Expensive and time-consuming: when used as treatment, high doses must be delivered over multiple days
BNAD101 increases intracellular NAD
For NAD to have biological activity, it must enter the cell
- BNAD101 rapidly and significantly increases intracellular NAD by 52% within 5 days of oral administration compared to placebo
- Most studies of current NAD precursor products rely on extracellular, circulating NAD measurements or surrogate metabolic markers, such as degradation products in blood and urine as proof of efficacy
Day 11=Day 4 on treatment.
Day 13=One day post-treatment.
Demonstrated
proof-of-concept
Proven increase in intracellular NAD with BNAD101 vs placebo (P=4.13×10-13)
In 2022, Bryleos successfully completed a randomized clinical trial (N=60) demonstrating proof-of-concept in healthy adults.
- Levels of NAD+ in cells increased rapidly and significantly
- 52% increase in just 5 days
- Well tolerated; favorable safety profile
BNAD101 innovation is a catalyst for growth
BNAD101: Pipeline in a drug
The exploratory endpoints of the proof-of-concept study looked at proteomic and metabolomic markers, as well as clinical chemistries at baseline and following 5-day administration.
Statistically significant differences in proteins and metabolites between BNAD101 and the placebo group were observed in additional key areas:
Neurodegenerative and neuropsychology
NAFLD/NASH
Metabolic
Cardiovascular
BNAD101: Pipeline in a drug
The exploratory endpoints of the proof-of-concept study looked at proteomic and metabolomic markers, as well as clinical chemistries at baseline and following 5-day administration.
Statistically significant differences in proteins and metabolites between BNAD101 and the placebo group were observed in additional key areas:
PRIORITY #1: Innovative detox care for patients going through substance use withdrawal
Over 49 million Americans struggle with substance use disorder, translating to a total addressable market of $118 billion.
The agony of drug and alcohol withdrawal is a harrowing experience, presenting a formidable obstacle to effective treatment. The current standard of care fails to provide timely relief, leaving patients desperate for immediate solutions. BNAD101 has the potential to mitigate withdrawal symptoms for xylazine, fentanyl, methamphetamines, short-acting opiates, benzodiazepines, alcohol, and any combinations thereof.
A significant differential effect of BNAD101 was observed on 13 biomarkers and 7 metabolites, as well as oxidative and nitrosative stress, directly related to neuropsychology, neurodegenerative disease, and neuronal health and function in general.
BNAD101 has the potential to serve a significant global market, bridging a material gap across all patient needs
Fearlessly committed to changing how the world thinks about costly chronic diseases
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