South Korea-based biotechnology company DR.NOAH BIOTECH has received approval from the US Food and Drug Administration (FDA) for a Phase I clinical trial of NDC-011, a potential treatment for amyotrophic lateral sclerosis (ALS).
NDC-011 is a two-drug combination that the company developed using its AI-driven drug discovery platform, ARK.
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The Phase I trial will be held at a clinical trial institution in the US and enrol a total of 24 healthy adult participants.
It aims to compare and assess the safety, bioavailability and tolerability of the individual components of NDC-011 and the combination therapy itself.
The trial is scheduled to begin in the first half of next year, with a Phase II trial expected to begin in 2026.
NDC-011 is designed to address multiple mechanisms of action in ALS patients, such as anti-inflammatory effects, neuroprotection, promotion of neuronal differentiation, and muscle cell protection.
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By GlobalDataARK analysed ALS patient data and evaluated more than 1.6 million drug combinations to identify potential candidates, ultimately selecting NDC-011 after it showed the ‘most significant’ preclinical results.
Preclinical studies have demonstrated that NDC-011 delays motor function deterioration and prolongs survival in ALS models.
In September last year, NDC-011 secured orphan drug designation from the FDA.
A DR.NOAH representative said: “Although there are currently approved medicines for ALS, their therapeutic effects fall short of expectations, making the development of new treatments an urgent necessity. NDC-011 is expected to alleviate the progression and symptoms of ALS and prolong patient survival.
“Our company is not just an AI technology service provider, but a drug development company capable of handling on our own the entire new drug development process from discovery to clinical development.”
DR.NOAH is currently developing eight different combination drug pipelines, including NDC-002 for stroke recovery and NDC-026 for the treatment of Duchenne muscular dystrophy.
