When Helsinki-based nanoparticle specialist Nanoform Finland went public this summer, it set out to dose the first volunteer in a study of its drug formulation technology by 2021. Now, moving ahead of schedule, the company plans to kick-start the trial before the year is out.
Nanoform has launched a GMP campaign to support its first in-human study of a "nanoformed" drug developed using its controlled expansion of supercritical solution (CESS) technology pegged to start later this year, the company said recently.
The company will test a nanoformed, immediate release oral formulation of the decades-old anti-inflammatory drug piroxicam—sold by Pfizer as Feldene—in 12 volunteers in the U.K. It’s the team’s hope that the smaller drug particles created using its CESS platform will enable piroxicam to act faster at a lower dose than the standard capsule, the company's head of manufacturing, David Rowe, said on an investor call.
To support the trial, Nanoform has teamed up with CDMO and CRO Quotient Sciences, on the hook to run the study at its facilities in Nottingham, England.
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Nanoform will manufacture the nanoformed piroxicam active pharmaceutical ingredient (API) itself, which Quotient will then use to develop a standard drug formulation, Chief Technology Officer Niklas Sandler said. Trial results are expected sometime before the second quarter of next year.
Volunteers will be split into two groups, with half receiving nanoformed piroxicam and the other half a standard capsule. After a washing out period, the groups will switch, with subjects receiving whichever formulation they didn’t get in the first round to compare results.
Nanoform hopes the trial will tee up development of fast-acting forms of piroxicam, but it also sees the study as a chance to make a case for its CESS platform to reformulate and deliver a wide array of drugs. As for the decision to go with piroxicam specifically?
“I like speed and I like precision and this is the opportunity we could grab fastest,” Nanoform CEO Edward Hæggström said during the call.
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The team’s CESS platform allows for the creation of API nanoparticles directly from solution by controlling the solubility of the ingredient in supercritical carbon dioxide. This process allows the company to create nanoparticles that are uniform in shape. CESS also enables the team to make nanoparticles as small as 10 nm—beneficial given that smaller particles have greater active surface areas.
In preclinical testing, Nanoform showed its CESS-made piroxicam could allow the drug to work at lower doses, with further dose reduction expected when using even smaller nanoparticles.