Biotech company Bridge Biotherapeutics Inc revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) orphan drug designation (ODD) to promote the development of the drug candidate BBT-877 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive, irreversible and fatal lung disease.
The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and has been under the development process by the lead of Bridge Biotherapeutics since the company acquired the worldwide exclusive right for further developments in 2017.
According to the company, BBT-877 is a potent best-in-class Autotaxin (ATX) inhibitor deregulates ATX, the enzyme found to be engaging in inflammation and fibrosis by generating the lipid signaling molecule. BBT-877 is the second molecule under the US FDA's clearances of IND for proceeding clinical studies.
In August 2018, the company gave a presentation of the results of the preclinical study on BBT-877 at the IPF Summit, attracting pulmonologists' interest on the efficacy and safety of the drug candidate. The data has demonstrated the best-in-class opportunity in comparison to a current development pipeline compound.
Additionally, the company will launch a Phase 1 study of BBT-877 in the US next month to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers. The planned study will be performed in two phases, a Single Ascending Dose (SAD) phase with five cohorts and a Multi Ascending Dose (MAD) phase with three cohorts. The estimated primary completion date is currently expected in late 2019.
PepGen receives FDA designations for Duchenne muscular dystrophy therapy
Pfizer's PREVENAR 20 gains European Commission approval for paediatric pneumococcal vaccine
Astellas Pharma's CRESEMBA receives orphan drug and paediatric exclusivity from FDA
SK Biopharmaceuticals' cenobamate achieves 100,000 patient treatment milestone
Calliditas Therapeutics' Nefecon receives additional seven years orphan drug exclusivity from US FDA
Merck finalises acquisition of Harpoon Therapeutics Inc
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Celltrion USA submits CT-P39 Biologics License Application to FDA
iOnctura's first-in-class autotaxin cancer therapy granted US FDA Orphan Drug Designation
Epitomee submits Weight Loss Capsule for FDA approval in US
Calliditas Therapeutics TARPEYO receives seven years orphan drug exclusivity from US FDA
Camurus reports Oclaiz NDA accepted by FDA for acromegaly treatment
TME Pharma plans NOX-A12 Phase 2 trial in brain cancer after FDA IND clearance