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PRNB

Principia Biopharma

$26.90 /

-0.14 (-0.52%)

07:02
10/10/19
10/10
07:02
10/10/19
07:02

Principia Biopharma announces preliminary data of PRN1008 from Phase 2 trial

Principia Biopharma announced preliminary data from its Phase 2 pemphigus, open-label, trial. Among all 15 patients in Part B of the Phase 2 trial, six patients have reached a complete response thus far, with four patients remaining on treatment who have the potential to still reach CR. There were five patients who were unable to achieve a CR. To date, nine of the 15 patients enrolled in Part B have achieved a PDAI score of 1 or 0. The primary efficacy endpoint results have been similar in Part A and Part B. In Part B, a starting dose of 400mg once daily was tested and it was determined to be less effective. At the recommendation of the Safety Monitoring Committee, all patients were escalated to twice daily dosing. Regarding safety, the preliminary data are consistent with Part A and no additional serious adverse events have been reported at doses up to 600mg twice daily. Additional data from this trial will be submitted for presentation at an upcoming medical conference and, with the last patient enrolled in June, Principia anticipates providing a further update by the end of the year. Principia earlier this year announced positive Phase 2 Part A trial data that included 27 patients with pemphigus in an open-label trial to evaluate PRN1008's potential to induce rapid onset of clinical response, enable tapering and/or avoidance of corticosteroids use, and lower autoantibody levels. In Part A, the observed CR rate was 25 percent for those patients who had been on therapy for 12 weeks. Principia is currently enrolling patients in a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial, the PEGASUS study, in approximately 120 patients to evaluate PRN1008 versus placebo, using a background treatment of tapering doses of corticosteroids. The trial entry criteria include patients with moderate to severe pemphigus who are either newly diagnosed or relapsing with chronic disease. This demographic will potentially represent three quarters of the pemphigus patient population. The primary efficacy endpoint is the ability of PRN1008 to achieve durable complete remission on very low-dose CS after 36 weeks of treatment. Durable complete remission is defined as a state in which all lesions have healed, and no new lesions have appeared for a period of at least eight weeks. Key secondary endpoints include cumulative CS use and time to complete remission. After 36 weeks, all patients will be treated with active PRN1008 therapy in an open-label extension period of 24 weeks. PRN1008 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of patients with PV and by the European Commission for treatment of patients with pemphigus.

PRNB Principia Biopharma
$26.90 /

-0.14 (-0.52%)

10/02/19 Stifel
Stifel remains buyer of Principia Biopharma into Q4 data readouts
07/01/19 H.C. Wainwright
Principia Biopharma initiated with a Buy at H.C. Wainwright
04/17/19
Fly Intel: Top five analyst initiations
04/16/19 Stifel
Stifel starts Principia at Buy ahead of 'catalyst rich' Q4

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