First Endolysin-based Orphan Drug Designated by US FDA
iNtRON Biotechnology has announced that N-Rephasin BAL200 for the treatment of anthrax infection has been received Orphan Drug Designation (ODD) from the US Food and Drug Administration (US FDA).
Orphan Drug Designation is a program of FDA to support for the new drug development of rare disease, which is designed to provide opportunities to patients with rare diseases to be treated with newly developing drugs. When designated as an Orphan Drug, developers receive a variety of benefits including fast track, 7-year market exclusivity, waive of NDA or BLA fee, tax refunds and etc.
It is very significant that BAL200 is a ‘fundamental’ therapeutic agent that can rapidly exterminate bacteria unlike the existing vaccines against anthrax. This characteristic is expected to increase potential possibility of BAL200’s single use and also in combination with existing anthrax vaccines. The Orphan Drug Designation of BAL200 is a meaningful first case shows the favorable view of the US government towards endolysin.
iNtRON is currently conducting clinical trial Phase 1b MAD and Phase 2a of SAL200, a new biologics for superbugs including MRSA. Upon completion of the planned clinical trials, iNtRON is planning to open US IND for the Phase 2 clinical trial. It is expected that the ODD of BAL200 will be helpful in several aspects for the US Phase II clinical trial of SAL200.
iNtRON will keep focus on R&D as a global leading company in bacteriophage and endolysin field. With intensive investments in various new drug fields other than antibiotics such as anticancer drugs, Botox alternatives, antifungal drugs and etc., iNtRON Bio will continue its step towards becoming a “Global R&D Group“.
it is iNtRON.