World's first tooth-regenerating drug to enter testing in Japan

A Japanese startup will launch clinical trials in September of what is believed to be the first-ever treatment that can regrow teeth, Report informs via Nikkei Asia.

Toregem Biopharma aims to bring the antibody drug to market in 2030 for patients missing some or all of their teeth from birth -- a condition known as congenital anodontia. The Kyoto University-affiliated startup hopes to eventually offer it to those who lose teeth later in life as well. It announced the clinical trials Thursday.

The antibody targets a specific protein that inhibits tooth growth. Tested in such animals as mice, it stimulated the development of tooth buds in the jaw, causing new teeth to form.

People with congenital anodontia, which affects an estimated 0.1% of the population, typically get implants or dentures in adulthood. No treatment currently addresses the condition's root cause.

"We want to make this a third option," said Toregem co-founder Katsu Takahashi, whose research the drug is based on.

The company is set to start Phase 1 physician-led clinical trials to ensure that the drug is safe. Testing will start with 30 healthy male adults who are unlikely to grow more teeth even if the drug works.

If all goes well, plans are to move on in 2025 to Phase 2 trials gauging effectiveness, with the treatment administered to patients aged 2 to 7 with congenital anodontia.

Toregem hopes to offer the antibody drug for 1.5 million yen ($9,800) and have it covered by health insurance.