GeNeuro reported (PDF) the near-total failure of its phase 2 long COVID trial Friday, telling investors it saw no effect on the primary endpoint and most secondary goals. The Swiss biotech responded by laying off staff and seeking strategic alternatives.
Geneva-based GeNeuro began testing the anti-HERV-W-Env antibody temelimab, also called GNC-501, in long COVID after seeing evidence immune dysregulation drives the post-infection symptoms. One study found the W-ENV protein on lymphocytes in people hospitalized with COVID-19. If expression continued after infection, the protein could damage cells and cause long-term neurological symptoms.
GeNeuro enrolled 203 people with long COVID at sites in Switzerland, Spain and Italy in the phase 2. All subjects tested positive at the start of the study for HERV-W-Env, the protein targeted by temelimab and the potential driver of long COVID’s neurological symptoms.
However, targeting the protein failed to improve health outcomes. GeNeuro saw no clinically meaningful improvement compared to placebo on the primary endpoint, which assessed fatigue, or on the majority of secondary objectives. Work to understand the data and the effect of temelimab on more biomarkers is continuing.
“Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures,” the firm said in a statement.
GeNeuro needed a win. A 5 million euro ($5.3 million) financing in February extended (PDF) the biotech’s cash runway into the third quarter, but, beyond that, the picture is unclear. The board responded to the long COVID failure by further reducing GeNeuro’s workforce and spending to conserve cash as it looks for strategic alternatives.
“The Swiss parent company GeNeuro SA has made redundant seven of its nine employment agreements, including all of the executive management. All employees and managers will work through their notice periods, of up to six months, to execute the strategy that will be defined by the board over the coming days,” the company said.
GeNeuro joins a list of companies that have swung at long COVID and missed. Pfizer's Paxlovid recently failed in the indication. Tonix Pharmaceuticals found its drug candidate had no effect on pain symptoms. Axcella ran out of money while going after long COVID.