Building on the successful completion of BAC’s U.S. FDA Phase IIa clinical trial, BOTA is advancing the 300-subject BOTA-NS clinical study in alignment with the FDA’s 2024 guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment, to accelerate the development of therapies for early-stage dementia.
Dementia
As populations continue to age, the number of people living with dementia is projected to exceed 130 million by 2050, creating a substantial healthcare and societal burden. Despite recent advances, significant unmet medical needs remain, highlighting the urgent demand for innovative therapeutic approaches.
People Living with Dementia Worldwide
57 Million+
Global Dementia Population
10 Million+
New Dementia Cases Each Year
82 Billion Hours
Spent Caring for People with Dementia Each Year
BAC-02
Alzheimer's Disease and Vascular Dementia
Alzheimer's disease (AD) and vascular dementia (VaD) are the leading forms of dementia worldwide. With dementia cases projected to exceed 130 million by 2050, significant unmet medical needs remain.
The growing disease burden is driving demand for innovative therapies targeting multiple disease pathways, creating substantial development and market opportunities in neurodegenerative diseases.
Source：
1.Alzheimer’s Disease International. Dementia statistics. Alzheimer’s Disease International.
2.Alzheimer’s Disease International. Vascular dementia. Alzheimer’s Disease International.
1.Alzheimer’s Disease International. Dementia statistics. Alzheimer’s Disease International.
2.Alzheimer’s Disease International. Vascular dementia. Alzheimer’s Disease International.
Alzheimer's Disease and Vascular Dementia Patient Population
Pre-Phase II Toxicology & Safety Studies Completed
U.S. FDA Phase IIa Clinical Trial Completed
BOTA-NS1
Dementia-Related Sleep Disorders
More than 60% of dementia patients experience sleep disturbances, including insomnia, disrupted sleep-wake cycles, and nighttime agitation. Current treatment options remain limited, highlighting a significant need for innovative therapies that improve sleep quality and support cognitive health.
Sources：
1.McCurry, S. M., & Logsdon, R. G. (2016). Sleep disturbances in dementia. Current Psychiatry Reports, 18(10), 87.
2.Lin, C. L., Chou, Y. C., Yang, J. C., Lee, C. H., Chen, Y. H., & Tsai, C. F. (2024). Sleep disturbances and emerging therapeutic strategies in dementia. Journal of Clinical Medicine, 14(19), 7119.
1.McCurry, S. M., & Logsdon, R. G. (2016). Sleep disturbances in dementia. Current Psychiatry Reports, 18(10), 87.
2.Lin, C. L., Chou, Y. C., Yang, J. C., Lee, C. H., Chen, Y. H., & Tsai, C. F. (2024). Sleep disturbances and emerging therapeutic strategies in dementia. Journal of Clinical Medicine, 14(19), 7119.
BOTA-NS2
Sleep Disorders
Sleep disorders have become a major global public health concern, with insomnia disorder being the most prevalent condition. According to the American Academy of Sleep Medicine (AASM) and epidemiological studies, approximately 10–30 % of adults worldwide suffer from insomnia, with prevalence exceeding 50 % among certain high-stress and elderly populations. Insomnia not only impairs sleep quality but is also closely associated with anxiety, depression, reduced attention, cognitive decline, cardiovascular diseases, and immune dysfunction. As a result, it is increasingly recognized as a significant health issue affecting both physical and mental well-being in modern society.
Current pharmacological treatments primarily include benzodiazepines, non-benzodiazepine hypnotics (Z-drugs), melatonin receptor agonists, and orexin receptor antagonists. However, these therapies may be associated with adverse effects such as daytime drowsiness, dizziness, increased risk of falls, cognitive impairment, tolerance, and dependence, particularly among elderly patients and long-term users. In addition, a considerable proportion of patients achieve only limited therapeutic benefit from existing treatments, highlighting the substantial unmet medical need in the sleep disorder field.
Against this backdrop, novel therapeutic approaches that offer improved safety, long-term usability, and multi-target mechanisms of action are gaining increasing attention. BOTA-NS2 aims to expand the therapeutic options available for sleep disorders by providing an innovative treatment approach that better addresses clinical needs. By targeting long-standing unmet needs among patients, caregivers, and healthcare providers, BOTA-NS2 demonstrates strong potential for sustainable clinical development and long-term market growth.
資料來源：
1.American Academy of Sleep Medicine. (2023). International classification of sleep disorders (3rd ed., text rev.). American Academy of Sleep Medicine.
2.Bhaskar, S., Hemavathy, D., & Prasad, S. (2016). Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. Journal of Family Medicine and Primary Care, 5(4), 780–784.
3.Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., et al. (2023). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 32(6), e14035.
4. Baird, B., Parker, A. M., & Walker, M. P. (2025). Sleep and brain health across the lifespan. NeuroImage, 317, 121124.
1.American Academy of Sleep Medicine. (2023). International classification of sleep disorders (3rd ed., text rev.). American Academy of Sleep Medicine.
2.Bhaskar, S., Hemavathy, D., & Prasad, S. (2016). Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. Journal of Family Medicine and Primary Care, 5(4), 780–784.
3.Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., et al. (2023). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 32(6), e14035.
4. Baird, B., Parker, A. M., & Walker, M. P. (2025). Sleep and brain health across the lifespan. NeuroImage, 317, 121124.
BOTA-NS3
Dementia (Novel Formulation)
Many dementia patients experience swallowing difficulties and reduced treatment adherence, limiting the effectiveness of conventional oral therapies. BOTA-NS3 is designed to improve administration convenience and support long-term adherence, addressing key unmet needs in dementia care.
Sources：
1.Quinn, C. C., Coyle, B. A., Beanland, C., & Tanner, E. E. L. (2016). Novel methods of drug administration for the treatment and care of older patients. International Journal of Pharmaceutics, 512(2), 366–375.
2.Alagiakrishnan, K., Bhanji, R. A., & Kurian, M. (2013). Evaluation and management of oropharyngeal dysphagia in different types of dementia: A systematic review. Archives of Gerontology and Geriatrics, 56(1), 1–9.
3.Chang, C. Y., Chen, J. Y., Wu, H. P., & Hsu, W. L. (2017). Medication adherence among older adults with chronic diseases. PLoS ONE, 12(1), e0170651.
1.Quinn, C. C., Coyle, B. A., Beanland, C., & Tanner, E. E. L. (2016). Novel methods of drug administration for the treatment and care of older patients. International Journal of Pharmaceutics, 512(2), 366–375.
2.Alagiakrishnan, K., Bhanji, R. A., & Kurian, M. (2013). Evaluation and management of oropharyngeal dysphagia in different types of dementia: A systematic review. Archives of Gerontology and Geriatrics, 56(1), 1–9.
3.Chang, C. Y., Chen, J. Y., Wu, H. P., & Hsu, W. L. (2017). Medication adherence among older adults with chronic diseases. PLoS ONE, 12(1), e0170651.