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Liberyx Therapeutics Announces FDA Authorization of IND for a Phase 1 Clinical Trial of LBX-100

HONG KONG, S.A.R., August 22, 2022 / -- Liberyx Therapeutics, an innovative drug development company solely focused on treating rare, pediatric neurometabolic diseases, today announced that it has received U.S. Food and Drug Administration (FDA) authorization of Investigational New Drug (IND) to proceed with a Phase I clinical trial of its lead compound, LBX-100.

The Phase 1 clinical trial is a placebo-controlled, double-blind study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LBX-100 in healthy subjects.

“We are excited that Liberyx is entering clinical development with the potential to meaningfully improve the lives of as nonketotic hyperglycinemia (NKH) and urea cycle disorders (UCD) sufferers and families. These neurometabolic disorders are marked by devastating symptoms with limited or non-existent disease-modifying treatments. We are confident that Liberyx’s therapies have meaningful potential to be safe, effective, and family-friendly treatments,” said Alex Yang, Chair of the Board and Chief Executive Officer of Liberyx Therapeutics.

Andrew O, Liberyx Therapeutics’ Investor Relations and Business Development Director further noted that, “Most critically, LBX-100’s rapid IND for Phase 1 advances us closer to a potential approval and relief for families. It also underscores the clear benefits of collaboration and leveraging of pre-clinical and Phase 1 data among Mstone platform portfolio companies.”

About Liberyx Therapeutics
Liberyx Therapeutics is an innovative biopharmaceutical company focused on developing treatments for rare diseases affecting children, primarily neuro-metabolic disorders such as glycine encephalopathy (also known as nonketotic hyperglycinemia) and urea cycle disorders. Liberyx is currently focused on developing four pipeline candidates, including two combination approaches, and was founded in 2021 with the support of Mstone Partners.

Liberyx Therapeutics’ largest shareholder is Mstone Partners, an entrepreneurial biotech incubator in the form of a holding company which owns and manages a portfolio of drug development companies. Mstone focuses on pediatric and repurposed drugs, rare and neurodegenerative diseases, and innovative technologies for targeted indications. Since its inception in 2016, Mstone has invested in two US and one HK company, which are now in advanced clinical-stages with the US FDA. Mstone has also established a number of portfolio companies under the Curestone Platform, which manages a portfolio of drug development companies in a centralized, hub-and-spoke model.

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Andrew O
Liberyx Therapeutics