Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology drug candidate in development as an orally-delivered psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug’s potential approval as it allows the FDA to rely, in part, on existing long-term safety data of an already approved drug, in this instance, Ziagen—thereby shortening development time and reducing costs. Prurisol is protected by a composition of matter patent.
Innovation has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate Chronic Plaque Psoriasis. Overall analyses showed the drug to appear safe, well-tolerated and efficacious in the highest dosing arm across 12 weeks of treatment. Patients with more moderate forms of psoriasis saw the greatest clinical improvements. Pharmacokinetic data further revealed an early and dose-dependent response that improved as treatment duration increased.
“A NEW ORAL PSORIASIS DRUG THAT DELIVERS
SUBSTANTIAL EFFICACY WOULD BENEFIT PATIENTS AND COMMAND CONSIDERABLE MARKET VALUE.”
— Dr. Arthur Bertolino
Innovation has begun enrolling patients in a Phase 2b trial of Prurisol in moderate-to-severe Chronic Plaque Psoriasis, assessing the drug's efficacy at higher dosing regimens. Due to its mechanism of action, Prurisol may also have applicability in treating other autoimmune-based diseases, such as Psoriatic Arthritis and Rheumatoid Arthritis.