Covington's Bexion Announces Progress from Meeting with FDA
Bexion Pharmaceuticals announced that it completed a Type B pre-IND in-person meeting with the U.S. Food and Drug Administration.
Type B meetings are explained by the FDA on its website here.
Bexion, based in Covington, is developing a drug known as BXQ-350, which has shown pre-clinical anti-tumor effects in brain and other solid tumors. It has already completed a multi-site Phase 1 clinical trial for solid tumors and gliomas. A Phase 1 pediatric trial opened in April of this year.
The meeting with FDA officials last week was related to the treatment of a rare pediatric disease, Diffuse Intrinsic Pontine Glioma (DIPG)/ Diffuse Midline Glioma (DMG).
As part of the overall Regulatory Strategy, Bexion had previously filed for and was awarded a formal Pediatric Rare Disease Designation for BXQ-350 in June of this year. This designation represents candidacy of BXQ-350 for a future Pediatric Rare Disease Voucher for DIPG, a news release said.
“This Type B meeting outcome now represents agreement with FDA on several points, allowing for a clearer and streamlined development path forward,” said Dr. Ray Takigiku, Founder and CEO. “This will benefit Bexion as it pursues development of this indication, as one important application in the BXQ-350 oncology platform.”