Expanded Access Policy

Vivoryon Therapeutics is committed to developing and commercializing safe and effective small molecule-based medicines which modulate the activity and stability of pathologically altered proteins for patients living with severe diseases with limited or no treatment options. We appreciate the urgency of bringing these innovative products to patients, and this commitment drives our work each day. We believe in the importance of collaborating closely with patients, their families, patient advocacy organizations, physicians, researchers and regulatory authorities to help achieve this goal. In these efforts, we are guided by ethical, scientific and legal principles, which require well-designed and controlled clinical trials to evaluate the safety and efficacy of our potential investigational medicines. Click here to visit the National Institutes of Health (NIH) website to learn more about clinical trials and how they work.

Our Approach to Clinical Development for Small Molecule-based Medicines

A robust and comprehensive clinical development program – designed with input from experts in the medical community, regulatory authorities and the patient community – is the optimal way to bring an approved therapy to the entire patient community. Clinical trials are designed and implemented to gain an understanding of the safety and efficacy of investigational new therapies in specific populations. Participation in clinical trials accepted by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities, is the best way for patients to access investigational therapies for their diseases.

It is our hope and intention to quickly enroll eligible patients into clinical studies in order to demonstrate the safety and efficacy of our investigational oral small molecule medicines, and to rapidly obtain the global regulatory approvals needed to make these therapies widely available to the patients that need them around the world.

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.