Principia Biopharma announces 'consistent positive data' for PRN1008
Principia Biopharma announced "consistent positive data" from an ongoing Phase 1/2 trial of its investigational treatment, PRN1008, in 31 highly treatment-resistant and refractory patients with immune thrombocytopenia. This analysis includes 31 adult patients who had a median baseline platelet count of 13,000 microliter. The patient population for this analysis had a median duration of disease of 7.8 years and a median of six prior ITP treatments. Oral PRN1008 starting doses were 200mg once daily, 400mg once daily, 300mg twice daily, and 400mg twice daily, with intra-patient dose escalation allowed every four weeks, and with the trial having a current median treatment duration of 12 weeks. "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," said Dr. Kuter, the trial's principal investigator. "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," said Martin Babler, Principia CEO.