Benitec Biopharma muscle disease therapy trial on track - H.C. Wainwright
25/11/2022 13:28
** H.C. Wainwright expects drug developer Benitec
Biopharma's BNTC.O applications for its early-to-midstage gene
therapy, BB-301, to remain on track for Q1 2023
** BB-301 is currently under development to treat
oculopharyngeal muscular dystrophy, a genetic disease that
affects the muscles of eyes, throat and limbs
** On Nov. 10, co said it expects to file regulatory
applications in the U.S. and Europe in the first calendar
quarter of 2023 to start early-to-midstage trials in the U.S.,
Canada and France urn:newsml:reuters.com:*:nGNX7K226Q
** Study is preceded by a 6-month observation period or a
Natural History (NH) trial, after which participants will be
eligible for enrollment onto the BB-301 treatment study
** "View NH trial as an important component of Phase 1b/2a
trial with regulatory approvals of the protocol having the
potential to keep the clinical development program on track" -
H.C. Wainwright
** Interim safety and efficacy data from the study expected
to become available for disclosure every 90-days following
BB-301 administration
(Reporting by Nandhini Srinivasan in Bengaluru)
((nandhini.srinivasan@thomsonreuters.com))