Priovant Therapeutics Unveils Promising NEPTUNE Phase 2 Study Results

Priovant Therapeutics recently unveiled promising results from the NEPTUNE Phase 2 study by testing the efficacy of brepocitinib in patients with non-anterior non-infectious uveitis (NIU), which can lead to severe visual impairment. This study highlights the potential of brepocitinib to revolutionize treatment paradigms in autoimmunity by specifically targeting a condition with few effective treatments currently available.

The study evaluated a total of 26 subjects with active NIU, and they were randomized to receive either 45 mg or 15 mg doses of brepocitinib. Remarkably, at week 24, the treatment failure rate was significantly lower in the 45 mg group (29%) when compared to the 15 mg group (44%), indicating a substantial improvement in disease management. Furthermore, the rate of treatment failure due to disease activity was reduced to 18% in the higher dose group, highlighting the effectiveness of brepocitinib.

The NEPTUNE study marked brepocitinib 45 mg to have the most favorable treatment failure rates among active NIU studies and additionally highlights its positive impact across all secondary efficacy endpoints. Also, the patients experienced significant improvements in the prevention and treatment of uveitic macular edema that can lead to vision loss.

With over 1,400 subjects treated in clinical trials, brepocitinib demonstrated a consistent safety profile similar to the approved JAK inhibitors without the identification of new safety concerns. This positions brepocitinib as a potential therapy for autoimmunity, especially with ongoing studies in dermatomyositis and the anticipated initiation of a pivotal NIU program.

A NEPTUNE investigator emphasized the urgent need for more effective treatments for non-infectious uveitis, which remains a significant cause of blindness in the U.S. The results on brepocitinib point to its potential as a transformative oral therapy for this debilitating disease. The dual inhibition mechanism of the drug offers a targeted approach to suppressing key cytokines involved in autoimmunity.

The CEO of Priovant expressed excitement over the outcomes of the study and the dose-dependent benefits observed across various measures of disease activity. He highlighted the rigor of the NEPTUNE study design to minimize false positives, strengthening the confidence in moving forward to Phase 3. The pipeline of Priovant Therapeutics is to launch a Phase 3 program in NIU in late 2024, with ongoing efforts in dermatomyositis expected to yield results by 2025.

Source

Therapeutics, P. (2024, April 2). Priovant therapeutics announces positive phase 2 NEPTUNE study results for brepocitinib in non-infectious uveitis (NIU), showing strongest efficacy data in NIU observed to date. PR Newswire. Read more.