Phase II
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
GSK and Ionis released promising trial data showing their investigational antisense oligonucleotide, bepirovirsen, could significantly reduce HBsAg and viral DNA levels in patients with CHB.
While it was a relatively quiet week for clinical trial announcements overall, BioSpace takes a look at some of the more intriguing ones.
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.
BridgeBio released early data from its Phase I/II CANaspire clinical trial, indicating that BBP-812 might be a promising gene therapy for the ultra-rare Canavan disease.
PhaseBio is working toward mitigating the surgical risks for cardiac patients taking antiplatelet therapies with bentracimab, which is currently in Phase III development.
Athira Pharma is putting a positive spin on its topline data from a Phase II trial of fosgonimeton, emphasizing positive subgroup analysis, but it missed the primary endpoint.
TC BioPharm is developing a new approach to chimeric antibody receptor (CAR) T-cell therapies with the potential to eliminate off-target effects, and possibly help more patients.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.
PRESS RELEASES