Nyrada Inc. Advances Brain Injury Program with GLP Studies and Capital Raise

Nyrada Inc. (ASX: NYR), a drug development company focused on novel small molecule therapies, provided a positive update on its Brain Injury Program.

Building on the success of its February preclinical stroke study where NYR-BI03 demonstrated neuroprotective efficacy, Nyrada has initiated Good Laboratory Practice (GLP) safety studies.

These studies, a regulatory requirement before human trials, are expected to take six months and evaluate cardiac safety, pharmacology, and toxicology.

Positive results will pave the way for a first-in-human Phase I clinical trial in the second half of 2024 (2H CY2024).

Phase I Trial to Assess Safety and Dosage in Humans

The Australian-based Phase I trial will assess how NYR-BI03 affects the human body, including determining safe dose ranges and identifying any potential side effects.

Key Highlights:

  • GLP safety testing of NYR-BI03 commenced expected completion in 2H CY2024.
  • Phase I clinical trial for NYR-BI03 on track for 4Q CY2024.
  • Successful capital raise of $1.755 million (before costs) in March 2024.
  • Ample funding to support GLP studies and the Phase I clinical trial.

Nyrada CEO James Bonnar said “NYR-BI03 represents a first-in-class therapy with a novel mechanism of action addressing a significant unmet medical need.

Stroke and traumatic brain injury are leading causes of death and disability globally, with no current FDA-approved treatments.

The encouraging results from our preclinical stroke study prompted us to initiate GLP studies, a crucial step toward human trials for NYR-BI03.”

Walter Reed Army Institute 

Nyrada is still on track to collaborate with the Walter Reed Army Institute of Research (WRAIR) on a separate brain injury study.

This study, initially delayed due to unforeseen personnel challenges, will now commence in early 2Q CY2024 and assess the effectiveness of NYR-BI03 in reducing injury size following penetrating traumatic brain injury (PTBI) in a rodent model.

Capital Raise Fuels Progress

Nyrada confirms receipt of the full $1.755 million from its March 2024 capital raise, with an additional $0.210 million expected in May 2024.

The EGM, scheduled for May 16th, 2024, will include proposals for issuing securities to Nyrada directors for purchasing CDIs under the same terms as the March capital raise.

With sufficient funding secured, Nyrada is well-positioned to progress its GLP studies, the WRAIR collaboration, and the Phase I clinical trial of NYR-BI03.


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