Medfacto announced in a regulatory filing that it submitted a Phase 1 clinical trial plan (IND) for its bone disease drug candidate 'MP2021' to the Australian Human Research Ethics Committee (HREC) on the 15th.

This Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MP2021, a novel osteoclastogenesis inhibitor, following a single intravenous dose in healthy adult volunteers. The trial will be conducted at 'Nucleus Network Sydney' in Sydney, Australia, with a maximum of 32 healthy adult participants. Specifically, the study is designed as a randomized, single-blind, placebo-controlled, dose-escalation trial, divided into up to four dose cohorts: 1.5mg/kg, 3mg/kg, 6mg/kg, and optionally 9mg/kg. The company stated that the primary objective of this trial is to confirm the safety and tolerability of a single intravenous dose of MP2021.

The overall clinical schedule is planned to span approximately two years, from the fourth quarter of 2026 to the fourth quarter of 2028.

Meanwhile, Medfacto noted in its filing that the statistical probability of the investigational drug receiving final marketing approval is approximately 10%. The company added that outcomes may fall short of expectations during this process, which could lead to changes or discontinuation of its commercialization plans. Furthermore, the company urged investors to invest prudently by comprehensively considering the investment risks disclosed through periodic filings and business reports.