SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Principia Biopharma Inc., a private clinical-stage biopharmaceutical company, today announced that initial Phase 1 clinical data for its fibroblast growth factor receptor (FGFR) 1-4 inhibitor, PRN1371, was presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. PRN1371 is an oral, irreversible covalent FGFR 1-4 inhibitor currently being evaluated in a Phase 1 dose escalation trial in patients with solid tumors to be followed by a dose expansion phase.
Clinical, pharmacokinetic and pharmacodynamic data from the ongoing international, multi-center trial were presented. The data demonstrated consistent pharmacokinetics with high apparent bioavailability, and robust pharmacodynamic impact on surrogate markers of serum phosphate and FGF23 levels. PRN1371 was well tolerated, with no dose limiting toxicities or any major off-target safety signals observed.
The presented poster will be available on the Scientific Publications section of Principia Biopharma's website at http://www.principiabio.com.
About FGFR inhibition in cancer
FGFR genetic alterations occur in a wide range of cancers including lung, breast, stomach, liver and bladder. These alterations may be amenable to targeted therapy designed to inhibit the effects of the alteration in driving tumor growth. Highly selective and potent FGFR inhibitors, such as PRN1371, may be able to slow or reverse tumor growth with a lower rate of side effects compared with less selective drugs.
About Principia Biopharma
Principia Biopharma Inc., a private clinical-stage biopharmaceutical company, has created a revolutionary new way to design and develop oral small molecule therapies that are more potent, selective, durable and safer than currently available drugs. The Company has utilized its proprietary Tailored Covalency™ technology to develop a portfolio of drug candidates that exhibit antibody-like specificity to benefit patients with autoimmune and inflammatory diseases and cancer. PRN1008, a reversible covalent BTK inhibitor, is currently being evaluated in a Phase 2 clinical trial in patients with pemphigus vulgaris, an orphan autoimmune disease affecting skin and mucous membranes. PRN1371, a covalent FGFR1-4 inhibitor, is currently being evaluated in a Phase 1 clinical trial in cancer patients with various solid tumors. For more information, please visit the Company's website at www.principiabio.com.