Principia updates anticipated final result from PRN1008 trial

Principia Biopharma Inc. recently updated about the anticipated timings for the final result from the ongoing trial of PRN1008 data in patients suffering from pemphigus, along with CRR (complete response rates) from its Phase II Part B trial (open-label).

For the record, Principia Biopharma is a late-stage biopharmaceutical company focused upon developing transformative oral therapies for patients with major unmet medical needs for immune-mediated diseases.

Dolca Thomas, MD and Chief Medical Officer of Principia Biopharma was reportedly quoted saying that the company is pleased to witness the interest in the Phase 3 PEGASUS trial and through the hard work of its study coordinators, investigators and clinical team, the enrollment timelines have speeded up. The final data from the trial which was supposed to be completed in the first half of 2022 will now be updated by the second half of 2021.

Thomas added saying that the company is exhilarated to witness a 40% CRR in the Phase 2 Part B trial (six patients) in spite of most patients being treated initially at a sub-therapeutic 400 mg daily dose.

Among the 15 patients which were dosed in Part B of the Phase 2 clinical trial, 60% (nine) of them achieved the primary endpoint of CDA (control of disease activity) by week 4 on low dose corticosteroids, which was equal to or less than 0.5 mg/kg per day.

12 out of 15 patients, equivalent to 80%, achieved control of disease activity by 12th week. 9 of the 15 patients (60%) have achieved a PDAI score of 1 or 0 (PDAI scoring system indicates disease severity). Safety and efficacy of PRN1008 turned out to be consistent with Phase 2 Part A trial and was also well-tolerated in Part B with no treatment-related serious AE (adverse event) reported. At an upcoming medical conference, final data from the Phase 2 Part B trial will be submitted for presentation.
 

Source Credit: https://ir.principiabio.com/news-releases/news-release-details/principia-updates-prn1008-pemphigus-clinical-program