Niagen Bioscience taps Evotec for NB4168 preclinical drug studies

Niagen Bioscience, Inc. (NASDAQ: NAGE) has selected Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT) as a contract research organization to conduct preclinical studies for NB4168, its oral small-molecule candidate being developed for Ataxia Telangiectasia (A-T), a rare pediatric genetic disease with no approved treatments.

Under the agreement, Evotec will conduct pharmacokinetic and pharmacodynamic studies and validate bioanalytical methods to support Niagen Bioscience's preclinical and Investigational New Drug (IND)-enabling activities. The work will be conducted at Evotec's campus in Verona, Italy, using its INDiGO platform, which integrates drug product development, safety, absorption, distribution, metabolism, and excretion, and regulatory and clinical services.

The studies will be conducted in collaboration with NAD Pharmaceuticals Corp., Niagen Bioscience's wholly owned subsidiary focused on therapies for accelerated aging and rare genetic diseases.

"This collaboration is an important step in building the pharmacological and bioanalytical evidence required to advance NB4168 toward clinical evaluation in patients with A-T," said Ozan Pamir, Chief Financial Officer of Niagen Bioscience.

In nonclinical pharmacokinetic studies conducted to date, NB4168 has shown higher blood exposure compared with NR chloride. NB4168 has received U.S. FDA Rare Pediatric Disease Designation and European Medicines Agency Orphan Medicinal Product Designation for the treatment of A-T. The company said it plans to submit an IND application to the FDA ahead of initiating human clinical studies.

A-T is caused by mutations in the ATM gene and affects approximately 1 in 40,000 people in the U.S. and 1 in 150,000 in Europe, according to published research cited in the press release.

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