Inozyme is committed to developing novel therapies to treat rare and seriously debilitating diseases of abnormal mineralization. Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe that focusing on initiation and conduct of clinical trials is the safest and most effective way of achieving this goal. Information about our clinical trials is available at www.clinicaltrials.gov.
Inozyme understands that some patients with no other viable treatment options may wish to access our medicines before results of a clinical trial are available, or they may not meet the eligibility criteria for an available clinical trial. Inozyme recognizes the need for Expanded Access Programs for these patients.
An Expanded Access Program for INZ-701 may be opened once Inozyme determines that all of the following criteria are met:
- The investigational drug is the subject of an active clinical development program.
- An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide expanded access to patients who do not have alternative treatment options.
- Expanded access will not impede or compromise the initiation, conduct or completion of clinical trials in timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.
- Sufficient scientific evidence demonstrating that the possible benefits of the investigational medicine outweigh the possible risks to the patient and that such risks are not unreasonable given the disease or condition to be treated.
Inozyme continues to assess the eligibility requirements and criteria for expanded access. At this time, an Expanded Access Program is not available. However, we are aware of a potentially high need and will re-evaluate the status of this policy on a regular basis.
If you have additional questions regarding this policy, please speak with your healthcare provider or contact: firstname.lastname@example.org.