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Principia Presents Consistent Positive Data of PRN1008 for Immune Thrombocytopenia in Ongoing Phase 1/2 Trial

ORLANDO, Fla., Dec. 07, 2019 (GLOBE NEWSWIRE) -- Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases, today announced consistent positive data from an ongoing Phase 1/2 trial of its investigational treatment, PRN1008, in 31 highly treatment-resistant and refractory patients (median of six prior therapies) with immune thrombocytopenia (ITP). The data from the trial is being presented today by David Kuter, M.D., Director of Clinical Hematology at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, at an oral scientific session of the 61st American Society of Hematology Annual Meeting (ASH).a??We are very encouraged by the data so far and pleased to see meaningful clinical responses and quick onset in this highly pre-treated patient population. We are also pleased to observe that this investigational drug so far has not seen the typical BTK class side effects,a?? said Dr. Kuter, the triala??s principal investigator.This analysis includes 31 adult patients who had a median baseline platelet count of 13,000/AµL (entry criteria were two platelet counts 30,000/AµL by the first week of treatment. Preliminary data on 13 patients treated at higher doses (300mg and 400mg twice daily) and who had completed at least 12 weeks of therapy, demonstrated a response rate of 54 percent (80 percent CI 37, 70) and 62 percent (80 percent CI 44, 77) for both endpoints respectively. To date PRN1008 has been well-tolerated at all doses studied, whether given as a monotherapy or with allowed concomitant ITP therapy (thrombopoietin and steroids), with no reported treatment related bleeding or thrombotic events. Related treatment emergent adverse events (TEAEs) were reported in 35 percent of patients and were all grade 1 or 2.a??As we continue to execute on our PRN1008 and BTK franchise strategy, these data represent yet another validation of our scientific platform as well as demonstration of our ability to develop oral therapies without compromising the desired efficacy or a favorable tolerability profile. We now have proof of concept in two immune mediated diseases,a?? said Martin Babler, Principiaa??s chief executive officer.
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