Overview and Clinical Trial Plans for the Tooth Growth Medication
In 2024, a medical startup originating from Kyoto University is progressing in the development of a revolutionary “tooth growth medication.” This medication promises hope to individuals suffering from congenital anodontia, a condition where permanent teeth do not develop.
Research Background
Congenital anodontia often results from issues with bone morphogenetic proteins (BMP) and a molecule called USAG-1. The medication works by inhibiting the activity of USAG-1, aiding the development of tooth germs (tooth buds), and thus promoting the growth of missing teeth.
Results from Animal Experiments
In animal trials, neutralizing antibodies were administered to mice, beagles, and ferrets, demonstrating tooth growth in areas previously lacking teeth. Based on these outcomes, clinical trials on humans are scheduled to begin in September 2024, aiming to develop a treatment for congenital anodontia.
The Path to Clinical Trials
From September 2024, the plan is to conduct human clinical trials. The startup has already received numerous inquiries from patients eager to participate, reflecting high social expectations for this treatment.
If successful, this innovative treatment could significantly improve the lives of many patients and profoundly impact the future of dental care.
The History and Details of Tooth Growth Medication Development
Related Companies & Universities
TreGem BioPharma Co., Ltd. – Founded based on research from Kyoto University, this company is advancing the development of medications aimed at regenerating teeth, specifically targeting congenital anodontia and is currently in the safety testing phase.
Kyoto University – The university’s oral and maxillofacial surgery research team plays a central role in this project, conducting basic research on USAG-1 antibodies, which contributes to the development of the tooth growth medication.
Fukui University – Also involved in this research project, contributing to the development of molecular-targeted drugs necessary for tooth regeneration.
Japan Agency for Medical Research and Development (AMED) – AMED is collaborating with Kyoto University and Fukui University to advance the development of regenerative dental treatments targeting USAG-1.
Kitano Hospital – The hospital where human clinical trials will begin in September 2024.
The Presence of Congenital Anodontia
Congenital anodontia refers to the condition where one is born missing one or more teeth. This disorder often has genetic components, particularly when six or more teeth are missing, with an occurrence rate of about 0.1% in the general population. Anodontia varies by the type of teeth missing (primary or permanent) and their emergence positions.
Initial Discoveries and Research
The development of the tooth growth medication is grounded in the elucidation of molecular mechanisms controlling tooth development and growth, particularly the roles of Wnt and BMP signaling pathways. Abnormalities in these pathways have been identified as causes of developmental disorders and congenital anodontia.
About Wnt
Wnt proteins are involved in a variety of biological processes including cell growth, differentiation, and migration, playing crucial roles in embryonic development, tissue regeneration, and cancer progression. There are two main types of Wnt signaling pathways:
- Canonical (β-catenin-dependent) pathway: Directly affects gene expression, involved in cell division and fate determination.
- Non-canonical (β-catenin-independent) pathway: Regulates cellular morphology and movement, contributing to tissue formation and cell polarity during developmental processes.
About BMP
Bone Morphogenetic Proteins (BMPs) are crucial signaling proteins involved in the development and repair of bones, blood vessels, and kidneys. Part of the Transforming Growth Factor β (TGF-β) superfamily, they transmit signals via Smad proteins inside cells, promoting bone and cartilage formation. Certain BMPs can induce ectopic bone formation, a property explored for therapeutic purposes.
The Discovery of USAG-1
Researchers at Kyoto University identified the molecule USAG-1 as playing a critical role in inhibiting tooth development by suppressing both BMP and Wnt signals. This discovery positioned USAG-1 as a target for therapeutic drugs promoting tooth regeneration.
Animal Experiment Details
The main focus of animal experiments has been on mice, particularly those genetically modified to lack the USAG-1 gene. In these mice, tooth buds, which normally degenerate, continued to grow and formed supernumerary teeth. This result suggests that inactivating USAG-1 protein through medication could potentially treat tooth absence.
Specific studies on genetically deficient mice showed that a single administration of anti-USAG-1 antibody restored tooth count, demonstrating the biological activity of increasing tooth numbers. This effect was observed in both mice and ferrets, leading to the selection of this antibody as a preclinical development candidate.
Comparison with Current Treatment Methods
Currently, dentures and implants are the main treatments for patients with congenital anodontia. Although effective, they often pose significant financial and physical burdens.
Limitations of Dentures and Implants
Dentures are typically more affordable but can be inconvenient for growing children who need size adjustments regularly. Implants, while durable, are expensive and require ongoing maintenance. They are also not suitable for minors who have not yet completed jaw growth.
The Potential of Tooth Growth Medication
The newly developed “tooth growth medication” significantly differs from traditional treatments by using injections to administer the drug, which by inhibiting USAG-1, actively promotes the growth of the patient’s teeth. This could lead to functional and natural-looking improvements, especially beneficial for young patients as it does not affect jaw growth.
Long-Term Impact
If commercialized, the “tooth growth medication” could provide many patients with an alternative to dentures and implants, enhancing treatment accessibility. This is particularly crucial for patients who previously had limited access due to economic reasons.
The Future Outlook: The Potential as a “Third Set of Teeth”
The “tooth growth medication” is expected to offer a new treatment option, replacing traditional dentures and implants. This innovative approach could significantly improve the quality of life for patients with anodontia or severe tooth loss.
Redefining Treatment
The “tooth growth medication” could fundamentally change the essence of dental treatment by enabling the growth of new teeth within the body, allowing patients to naturally restore their own teeth, achieving outcomes distinct from dentures and implants in both appearance and functionality.
Social and Economic Impact
Moreover, this treatment could reduce costs and make dental care more accessible, particularly in regions where medical expenses are high. The ease and reduced cost of treatment represent significant advancements in dental care.
According to Katsu Takahashi, chief of oral and maxillofacial surgery at Kitano Hospital, the cost is currently estimated at the price of three implants, which range from 300,000 to 400,000 yen each, making the tooth growth medication expected to cost between 900,000 and 1,200,000 yen.
Long-Term Outlook
Ultimately, this treatment aims to function as a “third set of teeth,” enabling people of all ages to maintain their own teeth throughout their lives. This could provide a means for everyone, not just the elderly, to preserve oral health.
Summary
The “tooth growth medication” developed by a startup from Kyoto University is garnering attention as a promising new treatment for patients with congenital anodontia. By inhibiting the action of the USAG-1 molecule, this medication promotes the growth of missing teeth. Animal experiments using mice, beagles, and ferrets have confirmed tooth growth in areas lacking teeth, paving the way for clinical trials in humans starting in September 2024 and raising high social expectations.
Multiple research institutions, including Kyoto University and Fukui University, are participating in this project, continuing efforts from basic research on congenital anodontia to clinical applications. Particularly, the understanding of Wnt and BMP signaling pathways, known to be factors in anodontia, is key to developing this therapeutic drug.
Compared to traditional treatments like dentures and implants, the “tooth growth medication” offers a more accessible option, especially for patients requiring costly treatments. If commercialized, this treatment could transform the paradigm of dental care by allowing patients to grow their own teeth, providing natural improvements in appearance and functionality.
This treatment, potentially functioning as a “third set of teeth,” aims to enable people of all ages to maintain their own teeth throughout their lives, significantly changing the landscape of dental treatment as research and development progress.