Mikart, LLC, a leading contract development and manufacturing organization (CDMO), and Nano PharmaSolutions, Inc. (NPS), a nanodrug delivery pharmaceutical company, 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."