Tooth-regeneration drug set for first trials in target patients

A Japanese biotech developing a drug aimed at regenerating teeth is moving towards its first trial in patients with the target condition, after raising US$5.3 million to support the study.

Toregem BioPharma said the Phase II trial would test its experimental antibody treatment in people with severe congenital hypodontia, defined by the company as the absence of six or more permanent teeth.

The Kyoto University spin-out said total funding, including grants and subsidies, had now exceeded US$29 million.

The drug, TRG035, works by blocking USAG-1, a protein that suppresses tooth development, with the aim of activating dormant tooth buds and stimulating new tooth growth.

Phase I trials in healthy adults with at least one missing tooth concluded without serious adverse events.

Unlocking the third dentition

The approach is rooted in the concept that humans retain vestigial tooth buds capable of producing a third set of teeth, but that USAG-1 normally prevents these from developing.

For paediatric patients with severe hypodontia, the clinical stakes are significant. Because implants cannot usually be placed until jaw growth is complete, children may be managed with removable dentures for years, with potential consequences for function, nutrition and quality of life.

However, TRG035 remains experimental and has not yet been shown to regrow teeth in humans.

While researchers ultimately hope the approach could be used for adult patients with acquired tooth loss, that remains a longer-term goal.

Follow Dentistry.co.uk on Instagram to keep up with all the latest dental news and trends.