Converting From A Spray-Dried Dispersion To A KinetiSol Formulation In <5 Months

A Phase 2 oral program faced significant obstacles: limited bioavailability, an impractically high pill burden, and a manufacturing process requiring lengthy mixing, extended spray‑drying times, solvent use, and multiple secondary steps. The development team conducted a rapid feasibility assessment and generated prototypes within weeks, demonstrating a substantial improvement in exposure. Building on those promising results, they advanced the reformulated version through clinical development, scale‑up, and clinical material production in under five months—far faster than typical timelines.

Subsequent human testing confirmed a marked boost in bioavailability compared with the original formulation, enabling a lower pill burden and simplifying both dosing and patient experience. The updated process also eliminated solvent and nitrogen requirements, reduced manufacturing time by more than half, and removed the need for secondary processing. Together, these improvements strengthened the program’s clinical profile, enhanced scalability, and increased the long‑term value of the asset.