Vivoryon Therapeutics’ glutaminyl cyclase inhibitor has failed a second phase 2 Alzheimer’s disease study this year, leaving the German biotech trying to find a silver lining in the drug’s potential to improve kidney function.
The company had been testing the candidate, varoglutamstat, across a pair of phase 2 Alzheimer’s trials centered in Europe and the U.S., respectively. The European trial, dubbed VIVIAD, missed all of its endpoints back in March, wiping off 90% of Vivoryon’s share price.
Early Monday morning, the Munich-based biotech providing an overview of the U.S. study, called VIVA-MIND, and it’s a similar story. When it came to the study’s primary endpoint of a dementia score, or key secondary endpoints that involved various evaluations of cognition, there were “no clinically meaningful and no statistically significant differences” between patients receiving 600 mg of varoglutamstat twice a day or placebo.
Vivoryon CEO Frank Weber, M.D., said these data across the board in Alzheimer’s "confirm the data seen in VIVIAD and are therefore not unexpected.”
To try to put a sunnier spin on the findings, the biotech focused on analysis of kidney function in the study’s patients, which it said revealed a “statistically significant improvement of >4mL/min/1.73m2 in the estimated glomerular filtration rate” (eGFR) in individuals who received varoglutamstat.
“These data reinforce the previously reported beneficial effect of varoglutamstat on eGFR in the completed phase 2b VIVIAD study and support the company’s development strategy to advance into a phase 2 study in diabetic kidney disease (DKD).”
The first Alzheimer’s fail in the spring initially looked like the end of the road for varoglutamstat, with Jefferies analysts saying at the time that it was “difficult to see a path forward” for the drug. But, by July, the company had reassessed the VIVIAD data and decided that hope lay in DKD.
However, details on the planned phase 2 study in this indication remain vague, with the company saying as recently as October that the timing and execution of this trial will be “subject to additional funding/partnership.”