KYOTO, Japan – In a groundbreaking advancement, Japanese pharmaceutical startup Toregem Biopharma is on the verge of introducing a pioneering drug that promises to stimulate the growth of new teeth.
Backed by Kyoto University, the team has been diligently working on this innovative treatment for years, targeting a protein called USAG-1, which inhibits tooth growth.
The Science Behind the Breakthrough
The drug works by using antibody treatment to deactivate the growth inhibiting protein, thus allowing “tooth buds” to develop into baby or permanent teeth.
This promising discovery, initially tested on mice in 2018, has shown remarkable results. Following successful experiments on mice, additional tests on ferrets have further validated the drug’s potential.
Upcoming Clinical Trials
Toregem Biopharma is set to commence clinical trials on healthy adults by July 2024.
This phase is crucial to confirm the safety of the drug before it can be made available to the public.
According to Katsu Takahashi, co-founder of Toregem Biopharma and head of dentistry and oral surgery at Kitano Hospital in Osaka, the drug’s impact could extend beyond filling gaps in smiles.
“Missing teeth in a child can affect the development of their jaw bone. We hope the drug will serve as a key to solving those problems,” Takahashi explained.
Addressing Congenital Anodontia and Beyond
The startup aims to conduct a clinical trial in 2025 specifically targeting children aged 2 to 6 with anodontia, a condition where children are born without some or all permanent teeth.
This could offer a much-needed solution for children facing such dental challenges.
Additionally, there are plans to extend the use of the drug to adults who have lost teeth due to cavities, potentially providing a non-invasive alternative to traditional dental procedures.
Market Launch and Future Prospects
Toregem Biopharma aims to bring this revolutionary antibody drug to market by 2030.
The initial focus will be on patients with congenital anodontia, a condition affecting about 0.1 percent of the population.
Currently, individuals with this condition typically resort to implants or dentures in adulthood, as no treatment addresses the root cause.
“We want to make this a third option,” said Takahashi.
The Phase 1 clinical trials, set to start with 30 healthy male adults, will ensure the drug’s safety.
If successful, the Phase 2 trials will begin in 2025, focusing on children aged 2 to 7 with congenital anodontia.
Toregem hopes to offer the drug for approximately Sh1.25 million (1.5 million Japanese Yen).
