A planned Phase IIa trial of an experimental tooth-regeneration drug will involve 24 children with severe congenital tooth agenesis, Toregem BioPharma has said.
The Japanese biotechnology company said the Pharmaceuticals and Medical Devices Agency (PMDA) had completed its investigation of the clinical trial notification for a tooth regrowth medicine called TRG035.
Toregem said the study must now undergo institutional review board assessment before it can begin enrolling participants and administering the investigational drug. Toregem did not announce a proposed start date for the Phase IIa study.
The open-label, non-comparative, multicentre study will investigate dosing in children with severe congenital tooth agenesis. It would move testing of TRG035 from healthy adults into patients with the condition the drug is intended to treat.
TRG035 already tested in adults
TRG035 has already undergone human testing in a Phase I study at Kyoto University Hospital, which began in October 2024.
The registered study had a target sample of 30 healthy adult men aged between 30 and 64 who were missing at least one molar. It was a randomised, double-blind, placebo-controlled dose-escalation study designed primarily to assess safety.
Toregem said Phase I confirmed the drug’s safety, although detailed results have not been made publicly available.
In June, Toregem BioPharma announced it had raised US$5.3 million to support the next stage of development.
The study forms part of wider research into whether tooth regrowth could eventually become possible in adults, although Toregem’s current clinical programme is focused on congenital tooth agenesis in children.
How is TRG035 intended to work?
TRG035 is an antibody treatment designed to block USAG-1, a protein involved in suppressing tooth development. Toregem hopes this will allow dormant tooth buds to develop and form new teeth.
The company has reported positive findings in animal models, but TRG035 has not yet been shown to regenerate teeth in humans.
Toregem said: ‘If administration of TRG035 enables tooth formation, patients will be able to eat using their own teeth throughout their lives.’
Its initial development is focused on severe congenital tooth agenesis. The company ultimately hopes to investigate whether the treatment could address teeth lost through dental decay and periodontal disease, but this remains a longer-term ambition.
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