Mikart and Nano PharmaSolutions Report Promising Trial Results
Mikart, LLC, a prominent contract development and manufacturing organization (CDMO), alongside Nano PharmaSolutions, Inc. (NPS), a cutting-edge nanodrug delivery pharmaceutical company, has unveiled encouraging findings from the ongoing Phase 1 clinical trial of NT-301. This revolutionary powder nasal spray is being developed to manage Parkinson's disease OFF episodes.
Insights from the Phase 1 Clinical Trial
The most recent data indicates that NT-301, produced at Mikart's GMP facility, leverages NanoTransformer® technology. This patented platform significantly enhances drug solubility and bioavailability while facilitating rapid absorption through the nano-coating of active pharmaceutical ingredients (APIs). Such advancements enable optimized delivery of otherwise poorly soluble drugs, which can be a game changer in various treatment methods.
Key Findings from the Interim Data
Initial blinded pharmacokinetic (PK) results from administering single ascending doses ranging from 1-3 mg of NT-301 powder nasal spray have revealed dose-proportional exposure and a brief absorption time. The Tmax, or time to reach maximum plasma concentration, is approximately 20 minutes in healthy volunteers. Dosing for the 4 mg cohort has commenced, with expectations of an even shorter Tmax at higher dosage levels.
Kay Olmstead, Ph.D., MBA, the CEO and Co-Founder of Nano PharmaSolutions, expressed enthusiasm about the interim findings: "Fast and reliable reaction times are essential for patients requiring on-demand medications. The data for NT-301 emphasizes the transformative capability of NanoTransformer® technology to enhance treatment options for individuals with Parkinson's disease. We are eager to continue this collaboration with Mikart, whose manufacturing expertise builds a robust foundation for further development."
Advancements in Nanotechnology and Drug Delivery
Nazar Elkarim, PhD, Vice President of Product Development Services at Mikart, highlighted the achievement: "The successful utilization of NanoTransformer® in the NT-301 development showcases the strength of our dedicated product development teams at Mikart. This joint effort not only emphasizes our capacity to manage complex nanoparticle formulations but also highlights our commitment to expediting the creation of pioneering therapies addressing immediate medical needs."
About Nano PharmaSolutions
Nano PharmaSolutions, Inc. is based in San Diego, specializing in developing nanotechnology solutions tailored for the pharmaceutical sector. Their patented NanoTransformer® platform is particularly effective in improving the solubility and bioavailability of water-insoluble molecular drugs. NPS is not only advancing its proprietary portfolio of central nervous system (CNS) medications but is also collaborating with various pharmaceutical companies to enhance the delivery of challenging APIs.
The NanoTransformer® technology employs a unique physical vapor deposition (PVD) process to nano-coat drugs onto hydrophilic excipients under ultra-high vacuum conditions, without solvents or polymers. This innovative approach results in improved solubility and expedited drug absorption across a diverse range of compounds. The Nano-CNS™ nasal spray platform presents an exciting potential path for the direct delivery of CNS therapies to the brain through olfactory and trigeminal pathways, effectively bypassing the blood-brain barrier.
Mikart's Role as a Leading CDMO
Founded in 1975, Mikart stands out as a premium contract development and manufacturing organization, excelling in the production of small molecules and potent compounds. Mikart provides an extensive array of oral dosage forms such as solids, liquids, and suspensions, along with comprehensive development, analytical, packaging, and manufacturing services tailored to expedite the commercialization of pharmaceutical products. The company’s dedication to quality, innovation, and collaboration positions it as a leading partner in addressing the evolving needs of the pharmaceutical industry.
Contact Information
For further inquiries, contact:
Michelle Hall
VP, Marketing,
Mikart, LLC
Frequently Asked Questions
What is the NT-301 trial about?
The NT-301 trial is a Phase 1 clinical study evaluating the safety and pharmacokinetics of a proprietary powder nasal spray aimed at treating Parkinson’s disease OFF episodes.
What technology does Nano PharmaSolutions utilize?
Nano PharmaSolutions employs the patented NanoTransformer® technology, which enhances drug solubility and bioavailability through a specialized nano-coating process.
How does NT-301 improve drug delivery?
NT-301 uses advanced nanotechnology to optimize the delivery of poorly soluble drugs, facilitating quicker absorption and therapeutic effect.
Who are the key collaborators in this trial?
Mikart, LLC and Nano PharmaSolutions, Inc. are the primary collaborators in the development and manufacturing of NT-301.
What are Mikart's core services?
Mikart specializes in offering extensive CDMO services, including development, analytical testing, packaging, and manufacturing of various oral dosage forms.
