Nano PharmaSolutions and CDMO Mikart have announced limited data from an ongoing Phase 1 trial of Nano PharmaSolutions’ NT-301 apomorphine nasal powder, which is in development for the treatment of OFF episodes in Parkinson’s disease. Mikart is manufacturing the product for the SAD study, which is expected to enroll a total of 48 healthy volunteers. According to the announcement, dosing of the highest (4 mg) dose level is underway. The companies say that the 1-3 mg doses of NT-301 tested so far have demonstrated a Tmax of about 20 minutes.
The Nano PharmaSolutions web site also lists NT-401 intranasal riluzole for the treatment of dysphagia in patients with amyotrophic lateral sclerosis (ALS) and NT-501 riluzole nasal spray for the emergency treatment of traumatic brain injury as part of the company’s pipeline. The company recently posted on its LinkedIn page that it had received a new US patent covering “any drug nanoparticles on any excipient, made with NanoTransformer technology.”
Nano PharmaSolutions CEO Kay Olmstead commented, “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. We are excited to advance this program with Mikart, whose expertise in clinical and commercial manufacturing ensures a strong foundation for future development.”
Mikart VP of Product Development Services Nazar Elkarim said, “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.”
Read the Mikart and Nano PharmaSolutions press release
