Principia announces Phase 1 PRN1371 trial data for bladder cancer

Around 36 adult patients with advanced solid tumors have completed the Phase 1, open-label dose escalation segment of the PRN1371 trial. A late-stage biopharmaceutical company Principia Biopharma Inc. has reportedly announced data from its Phase 1, multicenter, open-label dose escalation medical trial of PRN1371, an irretrievable covalent FGFR1-4 kinase inhibitor, in patients with developed solid tumors. The announcement was made in Denver, Colorado at the AACR Bladder Cancer: Transforming the Field meeting. Reportedly, PRN1371 is a covalent, potent, highly selective FGFR1-4 inhibitor, which targets a cysteine residue in the kinase domain. This approach is capable to allow selective and sustained inhibition of FGFR without maintaining high systemic exposure of the drug. Around 36 adult patients with advanced solid tumors have completed the Phase 1, open-label dose escalation segment of the PRN1371 trial. PRN1371 has been noted to be well tolerated and two patients continued study. While the test was not designed to evaluate efficacy, stable disease after two 28-day treatment cycles had been observed in 11 out of 36 patients. The most common adverse event related to treatment was hyperphosphatemia, a recognized side effect of FGFR inhibitors. A companion expansion segment of the PRN1371 trial has been started in metastatic urothelial carcinoma patients involving identified FGFR genetic alterations at 35 mg per day dosage and is currently ongoing. Martin Babler, CEO and President, Principia Biopharma, reportedly stated that like other FGFR inhibitors, in a non-selected patient population, the company did not see complete or partial responses (PRs/CRs). However, the company is encouraged by the observed duration of stable disease by the established tolerability profile of molecule and by the remaining two patients on study, he further added. For the record, Principia Biopharma Inc., a late stage biopharmaceutical company, offers transformative oral therapies to patients with significant unmet medical requirements in immunology and oncology.   Source credit: https://ir.principiabio.com/news-releases/news-release-details/principia-presents-phase-1-data-prn1371-patients-metastatic