The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies, Soriot told Bloomberg in his first interview since the data was released.
“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” the CEO said.
Soriot said he did not expect the additional trial to hold up regulatory approvals in the U.K. and European Union, although clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results.
Soriot also disputed the notion that the lower-dose regimen was an error, saying that after researchers realized the dosing error they formally changed the trial protocol with the blessing of regulators.
Equillium nixes plan to start late-stage trials of COVID-19 treatment
Equillium (EQ -3.5%) slips but recovers much of its early 17% loss after saying it will not initiate the Equinox Phase 3 clinical trial to evaluate itolizumab in hospitalized COVID-19 patients, citing the “rapidly evolving” treatment landscape.
“Based on a thorough review of recent updates regarding the efficacy of new potential vaccines and other treatment options, we have made the strategic decision not to initiate our Equinox Phase 3 trial,” Equillium says.
The company plans to prioritize resources on expanding its program of using itolizumab in acute graft-versus-host disease, citing positive interim clinical data, as well as advancing lupus/lupus nephritis and uncontrolled asthma studies.
Equillium had received a Study May Proceed letter from the Food and Drug Administration just last month to begin a Phase 3 trial evaluating itolizumab.
FDA OKs Y-mAbs’ neuroblastoma treatment
Y-mAbs Therapeutics (NASDAQ:YMAB) +14.3% after-hours as the Food and Drug Administration grants accelerated approval of its Danyelza (naxitamab) cancer treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
Y-mAbs says the FDA approval was supported by clinical evidence from two pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease.
The company expects Danyelza will be available for use in the U.S. “in the coming weeks.”
