Mikart and Nano PharmaSolutions Reveal Promising NT-301 Trial Data and Expand Manufacturing Capabilities
On September 18, 2025, Mikart, LLC, a top contract development and manufacturing organization (CDMO), partnered with Nano PharmaSolutions, Inc. (NPS) to announce promising interim safety and pharmacokinetic results from the ongoing Phase 1 clinical trial for NT-301. This proprietary powder nasal spray aims to treat OFF episodes in Parkinson's disease patients.
Manufactured at Mikart's state-of-the-art GMP facility located in Atlanta, NT-301 harnesses the innovative NanoTransformer® technology, a patented platform by Nano PharmaSolutions. This unique approach enhances the solubility and bioavailability of pharmaceuticals, facilitating fast absorption by utilizing a nanoscale coating on active pharmaceutical ingredients (APIs). Such innovations hold the potential not only for improved treatments but also for delivering poorly soluble drugs effectively across various administration routes.
Recent blinded pharmacokinetic (PK) data revealed that the single ascending doses of NT-301, ranging from 1 to 3 mg, highlighted dose-proportional exposure and remarkable absorption speed, with Tmax around 20 minutes in healthy volunteers. The trial has commenced dosing for the 4 mg cohort, with the expectation of achieving even quicker Tmax at higher doses.
Kay Olmstead, Ph.D., MBA, CEO and Co-Founder of Nano PharmaSolutions, expressed optimism regarding the NT-301 interim data, stating, "Fast and reliable onset of action is crucial for patients who rely on on-demand medications. The results reinforce the transformative potential of NanoTransformer® technology in treating Parkinson's disease. We are thrilled to advance this program with Mikart, whose expertise in clinical and commercial manufacturing solidifies a robust foundation for future development."
Nazar Elkarim, Ph.D., Vice President of Product Development Services at Mikart, reiterated the successful application of NanoTransformer® technology in NT-301. He remarked, "This collaboration not only showcases our capacity to manage intricate nanoparticle formulations at GMP scale but also emphasizes our commitment to accelerating the development of revolutionary therapies that tackle pressing medical needs."
Nano PharmaSolutions, headquartered in San Diego, is a leader in nanotechnology pharmaceuticals. Its patented NanoTransformer® platform specifically enhances the solubility and bioavailability of challenging-to-deliver molecular drugs. While they pursue a pipeline of CNS (central nervous system) medications, they also collaborate with various pharmaceutical companies to elevate the delivery of complex APIs. The Nano-CNS™ nasal spray platform from NPS aims for expedited, direct delivery to the brain utilizing olfactory and trigeminal pathways, which may effectively bypass the blood-brain barrier—an essential feature for addressing CNS conditions.
Since its founding in 1975, Mikart has established itself as a premier CDMO specializing in the development and manufacture of small molecules and potent compounds across diverse oral dosage forms, including solids, liquids, and suspensions. They offer comprehensive services covering development, analytics, packaging, and manufacturing designed to expedite the commercialization of pharmaceutical products. Mikart prioritizes quality and collaboration, continuously expanding its capabilities to meet the dynamic needs of its clientele.
In summary, the positive interim data from the NT-301 Phase 1 trial signifies a crucial advancement for Parkinson's disease treatment and showcases how innovative technologies like NanoTransformer® can redefine drug delivery systems, enhancing patient care for those grappling with significant medical challenges.
Manufactured at Mikart's state-of-the-art GMP facility located in Atlanta, NT-301 harnesses the innovative NanoTransformer® technology, a patented platform by Nano PharmaSolutions. This unique approach enhances the solubility and bioavailability of pharmaceuticals, facilitating fast absorption by utilizing a nanoscale coating on active pharmaceutical ingredients (APIs). Such innovations hold the potential not only for improved treatments but also for delivering poorly soluble drugs effectively across various administration routes.
Recent blinded pharmacokinetic (PK) data revealed that the single ascending doses of NT-301, ranging from 1 to 3 mg, highlighted dose-proportional exposure and remarkable absorption speed, with Tmax around 20 minutes in healthy volunteers. The trial has commenced dosing for the 4 mg cohort, with the expectation of achieving even quicker Tmax at higher doses.
Kay Olmstead, Ph.D., MBA, CEO and Co-Founder of Nano PharmaSolutions, expressed optimism regarding the NT-301 interim data, stating, "Fast and reliable onset of action is crucial for patients who rely on on-demand medications. The results reinforce the transformative potential of NanoTransformer® technology in treating Parkinson's disease. We are thrilled to advance this program with Mikart, whose expertise in clinical and commercial manufacturing solidifies a robust foundation for future development."
Nazar Elkarim, Ph.D., Vice President of Product Development Services at Mikart, reiterated the successful application of NanoTransformer® technology in NT-301. He remarked, "This collaboration not only showcases our capacity to manage intricate nanoparticle formulations at GMP scale but also emphasizes our commitment to accelerating the development of revolutionary therapies that tackle pressing medical needs."
Nano PharmaSolutions, headquartered in San Diego, is a leader in nanotechnology pharmaceuticals. Its patented NanoTransformer® platform specifically enhances the solubility and bioavailability of challenging-to-deliver molecular drugs. While they pursue a pipeline of CNS (central nervous system) medications, they also collaborate with various pharmaceutical companies to elevate the delivery of complex APIs. The Nano-CNS™ nasal spray platform from NPS aims for expedited, direct delivery to the brain utilizing olfactory and trigeminal pathways, which may effectively bypass the blood-brain barrier—an essential feature for addressing CNS conditions.
Since its founding in 1975, Mikart has established itself as a premier CDMO specializing in the development and manufacture of small molecules and potent compounds across diverse oral dosage forms, including solids, liquids, and suspensions. They offer comprehensive services covering development, analytics, packaging, and manufacturing designed to expedite the commercialization of pharmaceutical products. Mikart prioritizes quality and collaboration, continuously expanding its capabilities to meet the dynamic needs of its clientele.
In summary, the positive interim data from the NT-301 Phase 1 trial signifies a crucial advancement for Parkinson's disease treatment and showcases how innovative technologies like NanoTransformer® can redefine drug delivery systems, enhancing patient care for those grappling with significant medical challenges.
Topics Health）
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