GeNeuro's Long COVID Trial Fails, Leading to Layoffs and Strategic Review

GeNeuro, a biotechnology firm based in Geneva, has announced the near-total failure of its phase 2 trial of temelimab, an anti-HERV-W-Env antibody, aimed at treating long COVID. This news was disclosed on Friday, revealing that the study did not achieve its primary endpoint, which focused on reducing fatigue, nor did it meet most of the secondary endpoints. Following this setback, the company has decided to lay off staff and explore strategic alternatives.

The rationale behind GeNeuro's decision to test temelimab in long COVID patients stemmed from evidence suggesting that immune dysregulation could be responsible for the persistent symptoms experienced after a COVID-19 infection. A particular study highlighted the presence of the W-ENV protein on lymphocytes in individuals hospitalized due to COVID-19. This protein, if expressed continuously post-infection, could potentially damage cells and lead to prolonged neurological issues.

In the phase 2 trial, GeNeuro enrolled 203 long COVID patients from Switzerland, Spain, and Italy. All participants tested positive for the HERV-W-Env protein at the study’s onset. This protein was the target of temelimab, believed to be a potential factor in long COVID's neurological manifestations. Despite these efforts, the trial showed no significant improvement in health outcomes compared to a placebo. The primary endpoint, which was the reduction of fatigue, remained unmet, and similar results were observed for most secondary endpoints.

The company is continuing to analyze the data to gain a deeper understanding of the trial results and the impact of temelimab on additional biomarkers. Preliminary analyses suggest that the duration of the disease at the time of inclusion and the evolution of the underlying HERV-W ENV status could influence the efficacy outcomes.

GeNeuro was in dire need of a breakthrough. In February, the company secured a 5 million euro ($5.3 million) financing, which extended its cash runway into the third quarter. However, the future remains uncertain beyond this period. In response to the trial's failure, the GeNeuro board has decided to further reduce the company's workforce and cut spending to conserve cash while seeking 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 stated.

GeNeuro now joins a growing list of companies that have attempted to develop treatments for long COVID but have fallen short. Pfizer's Paxlovid recently failed in this indication, Tonix Pharmaceuticals found no effect of its drug candidate on pain symptoms, and Axcella ran out of funds in its pursuit of a long COVID treatment.

GeNeuro’s experience underscores the significant challenges and uncertainties involved in developing effective treatments for long COVID. Despite promising initial data and a clear scientific rationale, the path to successful therapeutic interventions remains fraught with difficulties. The company’s next steps will likely focus on re-evaluating its strategy and seeking new directions to navigate the complex landscape of biotechnology and long COVID research.