Vivoryon Therapeutics NV

Expanded Access

Under certain circumstances, a person suffering a serious or life-threatening disease may ask to use an experimental treatment outside a clinical trial, before its safety and efficacy have been fully evaluated, and before the regulatory authorities have approved it. Generally, this is an option only for patients who have exhausted all available medical options and do not qualify for the ongoing clinical trials.

Vivoryon understands the intent of expanded access programs but, at this time, we can best advance the development of these potential promising products by enrolling patients in clinical trials which are designed to enable approval allowing access for the broader patient community. Our priority is to demonstrate the safety and effectiveness of varoglutamstat (PQ912), our investigational oral small molecule medicine in development to treat Alzheimer’s disease, in order to obtain regulatory approval and make it available to appropriate patients as rapidly as possible. We do this by running a thoughtfully designed and robust clinical trial program.

We are currently unable to offer expanded access for varoglutamstat (PQ912) and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies.

More Information

Treating physicians, patients and/or caregivers interested in learning more about Vivoryon’s investigational oral small molecule medicines currently undergoing clinical studies can find more information here or by or visiting www.clinicaltrials.gov and searching for Vivoryon Therapeutics.

If you are a health care provider who is interested in learning more about one of our investigational therapies, or a physician with questions about participation in one of our clinical trials, please submit a request to clinics@vivoryon.com. Vivoryon will acknowledge questions as soon as possible, usually within 5 business days of receipt.

If applicable, this website will be updated with hyperlinks to the relevant expanded access information on www.clinicaltrials.gov upon activation. As authorized by and in accordance with the 21st Century Cures Act, Vivoryon reserves the right to revise this policy at any time.