Priovant Therapeutics said that it intends to initiate a phase 3 program of brepocitinib in the second half of this year.
Positive results from a phase 2 trial evaluating the efficacy and clinical safety of brepocitinib for the treatment of non-anterior, non-infectious uveitis have been released, Priovant Therapeutics announced.1 The company noted that additional trial data will be presented at a future medical conference.
Results from the Neptune (
Trial Name: A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis
ClinicalTrials.gov Identifier: NCT05523765
Sponsor: Priovant Therapeutics
Summary: This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).
"Non-infectious uveitis is a devastating disease that can lead to severe visual impairment and contribute to tens of thousands of cases of legal blindness in the United States each year, including many instances of irreversible blindness," Quan Dong Nguyen, MD, MSc, FARVO, FASRS, an investigator on the Neptune study, said in a release.1 "Current treatment options provide inadequate benefits to many patients; thus, novel pharmacotherapeutic agents with better efficacy and more convenient methods of administration are urgently needed.”
The randomized, double-masked, dose-ranging phase 2 Neptune study assessed 45 mg once daily or 15 mg once daily of brepocitinib in patients with active intermediate, posterior, or pan non-infectious uveitis. The study cohort included 26 adult patients aged between 18 and 74 years who received 60 mg daily prednisone at the beginning of the study for 2 weeks and were tapered off by week 8.
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The primary study endpoint of treatment failure at week 24 was a composite of measures of ocular inflammation and visual acuity, as well as discontinuation due to intercurrent events or initiation of rescue therapy.
The study found that 29% patients in the brepocitinib 45 mg arm and 44% in the 15 mg arm met treatment failure criteria at week 24. The treatment failure rate from disease activity was 18% in the 45 mg arm. Secondary efficacy endpoints, such as haze grades, visual acuity, and macular thickness, were also positive and dose responsive. Additionally, safety and tolerability were consistent with prior clinical studies.
"The NEPTUNE study was designed to minimize likelihood of false signals of benefit, by tapering patients with active disease from 60 mg/day of prednisone to 0 mg/day in just six weeks, more than twice as fast as steroid tapers in precedent studies," Ben Zimmer, CEO of Priovant, said in a release.1 "Against that backdrop, we are thrilled to see a failure rate of only 29% in the brepocitinib 45 mg arm, better than any precedent study was able to achieve even with more lenient tapers. The magnitude and consistency of dose-dependent benefit across multiple independent measurements of inflammation, visual acuity, and macular edema give us high confidence heading into Phase 3.”
Priovant said in the release that it intends to initiate a phase 3 program in the second half of this year. The company is also evaluating brepocitinib to treat dermatomyositis in an ongoing phase 3 study. The dermatomyositis study is expected to be fully enrolled by the third quarter, with data expected in 2025.
“Brepocitinib's striking results on multiple endpoints of clinical significance position the drug to become a potentially transformative once-daily oral therapy for this debilitating disease and reinforce the distinctive mechanistic benefits of dual TYK2/JAK1 inhibition for highly inflammatory autoimmune diseases with multiple pathogenic cytokines, such as non-infectious uveitis,” said Nguyen.1
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