Mikart and Nano PharmaSolutions Announce Positive Interim Data from NT-301 Phase 1 Trial and Expansion of NanoTransformer® Manufacturing Capabilities

ATLANTA and SAN DIEGO, Sept. 18, 2025 /PRNewswire/ -- Mikart, LLC, a leading contract development and manufacturing organization (CDMO), and Nano PharmaSolutions, Inc. (NPS), a nanodrug delivery pharmaceutical company, today announced positive safety and pharmacokinetics data from the ongoing Phase 1 clinical trial of NT-301, a proprietary powder nasal spray being developed for the treatment of Parkinson's disease OFF episodes.

NT-301, a drug-device combination product manufactured at Mikart's GMP facility in Atlanta, is powered by NanoTransformer® technology, Nano PharmaSolutions' patented nanodrug manufacturing platform that improves drug solubility, enhances bioavailability, and enables fast absorption through nano-coating of active pharmaceutical ingredients (APIs), unlocking the potential to deliver poorly soluble drugs across a range of routes of administration.

Interim blinded pharmacokinetic (PK) data from single ascending doses of NT-301 powder nasal spray from 1-3 mg demonstrated dose-proportional exposure and rapid absorption (Tmax ~20 minutes) in healthy volunteers. Dosing of the 4 mg cohort has now begun, and investigators anticipate an even shorter Tmax at higher doses.

"Fast and reliable onset of action is critical for patients who need on-demand medicines," said Kay Olmstead, Ph.D., MBA, CEO and Co-Founder of Nano PharmaSolutions. "The NT-301 interim data reinforce the potential of NanoTransformer® technology to transform treatment for people with Parkinson's disease. We are excited to advance this program with Mikart, whose expertise in clinical and commercial manufacturing ensures a strong foundation for future development."

Nazar Elkarim, PhD, Vice President of Product Development Services at Mikart, commented: "The successful application of NanoTransformer® in NT-301 highlights the strength of our product development and technical teams at Mikart. This collaboration not only demonstrates our ability to execute complex nanoparticle formulations at GMP scale, but also underscores how we can help accelerate the development of breakthrough therapies that address urgent unmet medical needs."

About Nano PharmaSolutions
Nano PharmaSolutions, Inc. (NPS) is a San Diego–based nanotechnology pharmaceutical company with a patented NanoTransformer® platform designed to improve the solubility and bioavailability of poorly water-soluble molecular drugs. NPS develops its own pipeline of CNS medicines while partnering with pharmaceutical companies to enhance delivery of challenging APIs. The NanoTransformer® technology uses a patented physical vapor deposition (PVD) process to nano-coat drugs on hydrophilic excipient under ultra-high vacuum without solvents or polymers, resulting in enhanced solubility and faster absorption across a wide range of compounds. For CNS therapies, the Nano-CNS™ nasal spray platform has a pathway to direct, rapid delivery to the brain via olfactory and trigeminal pathways, potentially bypassing the blood-brain barrier.

About Mikart
Founded in 1975, Mikart is a premier CDMO specializing in small molecules, potent compounds, and a full range of oral dosage forms, including solids, liquids and suspensions. The company provides comprehensive development, analytical, packaging, and manufacturing services designed to accelerate the commercialization of pharmaceutical products. With a focus on quality, innovation, and partnership, Mikart continues to expand its capabilities to serve the evolving needs of its clients.

CONTACT:
Michelle Hall
VP, Marketing,
Mikart, LLC
mhall@mikart.com

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SOURCE Mikart, LLC