- Mikart, LLC and Nano PharmaSolutions, Inc. announced positive interim safety and pharmacokinetics data from the Phase 1 trial of NT-301, a powder nasal spray for Parkinson’s disease OFF episodes.
- The NT-301 drug-device product, manufactured at Mikart’s GMP facility in Atlanta, is powered by Nano PharmaSolutions’ NanoTransformer® nanodrug delivery technology.
Mikart, LLC, a contract development and manufacturing organisation (CDMO), and Nano PharmaSolutions, Inc. (NPS), a nanodrug delivery pharmaceutical company, have reported encouraging interim results from the ongoing Phase 1 clinical trial of NT-301. The proprietary powder nasal spray is being developed for the treatment of Parkinson’s disease OFF episodes.
NT-301 is a drug-device combination product manufactured at Mikart’s GMP facility in Atlanta. It uses Nano PharmaSolutions’ patented NanoTransformer® platform, designed to improve solubility, enhance bioavailability, and enable rapid absorption of poorly soluble drugs through nano-coating of active pharmaceutical ingredients.
Blinded interim pharmacokinetic data from single ascending doses of 1–3 mg demonstrated dose-proportional exposure and a time to maximum concentration of around 20 minutes in healthy volunteers. Dosing has now begun in the 4 mg cohort, with investigators expecting even faster absorption at the higher level.
“Fast and reliable onset of action is critical for patients who need on-demand medicines. The NT-301 interim data reinforce the potential of NanoTransformer® technology to transform treatment for people with Parkinson’s disease.”
Kay Olmstead, Ph.D., MBA, CEO and Co-Founder of Nano PharmaSolutions
Nazar Elkarim, Ph.D., Vice President of Product Development Services at Mikart, added that the collaboration demonstrated the CDMO’s ability to deliver complex nanoparticle formulations at GMP scale while supporting the development of therapies addressing unmet needs.
