Covid-19 roundup: Synairgen turns to post-hoc analyses after failed drug trial; EU terminates Valneva vaccine contract
After halting enrollment in an NIH-led Phase II/III study, and failing an earlier Phase III trial, UK-based Synairgen’s Covid-19 drug did show some promise in some select subgroups, the company said in its presentation of a post-hoc analysis on Monday at a conference in San Francisco.
Post-hoc analyses of the Phase III SPRINTER trial, which failed to hit its primary endpoints, showed an “encouraging signal in reduction in the relative risk (RRR) of progression to severe disease or death within 35 days (25.7% reduction in the Intention-to-Treat population and 36.3% reduction in the Per Protocol population).”
The company also tried to highlight “stronger treatment effects with SNG001 in these high-risk patient sub-groups, with the strongest effect observed in those who had clinical signs of compromised respiratory function.”
But the presentation may be a last-ditch effort to show investors something encouraging, even as the company has acknowledged it’s still looking to confirm those post-hoc analyses in a larger platform trial.
EU drops Valneva Covid-19 vaccine contract
Valneva’s stock price dropped by more than 20% early Monday as the company disclosed that the EU is no longer interested in its Covid-19 vaccine.
As the company’s contract with the EU outlined, the EU has the right to trigger its intent to terminate the advance purchase agreement for Valneva’s inactivated whole-virus Covid-19 vaccine candidate as the vaccine has not yet been authorized. Valneva has 30 days from last Friday to obtain a marketing authorization or propose an acceptable remediation plan.
The company announced late last month that it received further questions from the European Medicines Agency’s Committee for Medicinal Products for Human Use, which the company responded to on May 2. If CHMP finds Valneva’s responses acceptable, the company said it would expect to receive a positive CHMP opinion next month, at the latest.
In the UK, however, Valneva recently won a conditional marketing authorization for the primary immunization of adults 18 to 50 years of age.
Report finds significant Covid-19 drug research waste
Most clinical trials of potential Covid-19 drugs served as nothing more than research waste, delaying the identification of effective treatments, a new report from Transparimed and Health Action International finds.
The report reviews the integrity of clinical trials for Covid vaccines, repurposed drugs and non-pharma interventions, highlighting the success of trials like the UK-based RECOVERY trial, which delivered strong evidence on the efficacy (or lack thereof) of five widely investigated repurposed drugs (dexamethasone, hydroxychloroquine, azithromycin, lopinavir and ritonavir), and which the report said probably saved hundreds of thousands of lives worldwide – and made hundreds of smaller trials in other countries clinically irrelevant.
On the negative end, the report points to small trials run in Spain, the US, and China.
“Spain provides a clear example of the uncoordinated proliferation of futile Covid-19 trials,” the report says. “In addition, the widespread haphazard administration to US patients of experimental treatments (including HCQ and convalescent plasma) in non-trial settings reduced the pool of patients eligible for participation in trials. Researchers in China initially registered a large number of trials (apparently in an uncoordinated manner) but these never gained traction as infection rates there rapidly dropped to virtually zero.”
The report echoes similar sentiments expressed by FDA principal deputy Janet Woodcock and former NIH director Francis Collins, both of whom lamented the US trial landscape for Covid drugs.