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| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Stockholm, Sweden - April 24, 2025 - Inhalation Sciences AB (ISAB) has completed the FDA-funded study[1] of DissolvIt® (ISAB's proprietary unique methodology for dissolution testing of inhaled drugs) with successful results where all primary and secondary study objectives were confirmed to be met. After final minor amendments, the study report has now been approved by the FDA for publication.
"We are very pleased with the results of this comprehensive groundbreaking study that met both our primary and secondary study objectives and confirms our development hypothesis as well as previous results from our proprietary studies with DissolvIt®" says Manoush Masarrat, CEO of Inhalation Sciences and continues: "We are pleased that the FDA, after requesting minor amendments, has confirmed the positive results achieved. Now we can finally present the study results to pharmaceutical companies developing inhalation drugs and show how DissolvIt® can improve the drug development process in terms of time, cost and efficiency, and together with the FDA promote the publication of the study results in scientific journals."
The study, which included a total of 16 inhalation products, shows among other things that:
- DissolvIt® generates a unique and more detailed set of dissolution data than conventional methods provide, in addition to also reproducing the overall picture of dissolution these methods provide.
- DissolvIt® provides equivalent results to more expensive and complex laboratory animal-based methods for measuring lung dissolution such as Isolated Perfused Lung (IPL).
- DissolvIt® can detect small differences and rapid time courses in the dissolution profiles of different test formulations, which can be used to develop generic inhalation products in a more targeted manner.
The completion of the study with successful results comes at an interesting time as the FDA in late 2024 updated its regulatory guidance with recommendations for inhaled drug development to include dissolution testing as a key component for drug approval.[2]
As announced in a separate press release on March 3, 2025, the regulatory updates are expected to lead to an increased use of dissolution and with the positive approved study results from DissolvIt®, ISAB's position in the growing inhalation drug development market is expected to be strengthened.
"Following the FDA's recent update of the regulatory guidelines with recommendations on dissolution testing, we have seen an increasing interest in DissolvIt®, not least in the generic market where there is a great need for faster and more efficient development. With the positive result from this study, we expect that the interest will increase further for both DissolvIt® and ISAB in general ", says Manoush Masarrat and adds; "Now we have a technology that has been thoroughly evaluated by one of the world's leading regulatory authorities and can offer our customers an effective and reliable solution for the development of inhaled drugs."
For drug developers, DissolvIt®'s ability to generate results in preclinical tests that distinguish the efficacy of different candidates and predict how they will behave in the clinical phase can bring significant benefits by reducing risk, cost, and time in the otherwise complex inhaled drug development process.
Manoush Masarrat says: We have an interesting time ahead of us where we will present the study results to industry and investors. The US market is particularly interesting as there is a great need to increase the number of generic inhalation drugs available there. For ISAB, this has a potentially very high commercial value and is considered a breakthrough for our DissolvIt® technology."
For more information about Inhalation Sciences AB and DissolvIt®, please visit http://www.inhalation.se/.
[1] Contract 75F40122C00197 together with FDA BAA (Broad Agency Agreement), communicated earlier on September 15, 2022
[2] ISAB press release on March 3, 2025
This disclosure contains information that Inhalation Sciences is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on April 24, 2025 at 08:00.
For more information, please contact:
Manoush Masarrat, CEO
Mobile: +46 (0) 73 628 9153
E-mail: manoush.masarrat@inhalation.se
About Inhalation Sciences Sweden AB (publ)
Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company's patented lab instruments PreciseInhale® and DissolvIt® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, and so our health, when being inhaled.