Phase II
Initial results showed a strong neutralizing antibody response and favorable safety profile among the participants.
It was yet another busy week for clinical trial news. Here’s a look.
Late Thursday, Athira announced that Kawas had resigned from her position as CEO and president of the company.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
Redosing is a large and growing concern for gene therapy developers and regulators.
Calithera Biosciences is expanding its oncology portfolio with the addition of two clinical-stage compounds from Takeda Pharmaceuticals.
AT-527, an oral direct-acting antiviral agent that blocks viral RNA polymerase needed for viral replication, failed to meet its primary endpoint in the Phase II MOONSONG study.
On Monday, LogicBio Therapeutics unveiled clinical trial results demonstrating the first-ever in vivo, nuclease-free genome editing in little humans.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
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