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Expanded Access

Alterity Therapeutics is a clinical stage biotechnology company dedicated to developing disease modifying treatments for individuals with neurodegenerative diseases. We are a science-driven company committed to putting patients first.

Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients. We conduct clinical trials in collaboration with experienced physician investigators to assess the safety and efficacy of our investigational therapies. These data are then submitted to the U.S. Food and Drug Administration (FDA), the Therapeutics Goods Administration (TGA) in Australia or other regulatory authorities for review. This rigorous review process may result in the approval of safe and effective medicines that physicians can prescribe for their patients.

About Expanded Access

An Expanded Access Program, also known as a “Special Access Scheme” in Australia, “compassionate use”, or other similar names, is a potential pathway for a patient with a serious or life-threatening disease or condition to obtain access to an investigational therapy. Under very specific conditions (i.e., when individuals are not eligible for clinical trials, have no available treatment options, and/or have undergone appropriate standard treatment without success), regulatory authorities such as FDA or TGA may grant a company permission to provide a treating physician with an unapproved medicine for a specific patient.

Prior to approval, knowledge of the efficacy and safety profile of a drug candidate is limited, and therefore, expanded access to this investigational therapy may present risks for individuals. For individuals treated with an investigational therapy, expanded access may carry potential safety risks or a false sense that the medicine will provide benefit. Doctors and patients should consider all possible risks and benefits when seeking expanded access to an investigational drug.

For additional information from the FDA about expanded access in the U.S., click here.

For information about Australia’s special access scheme, click here.

Criteria For Expanded Access Of Alterity’s Investigational Therapies

An expanded access program may be opened if Alterity determines that the following criteria have been met:

  • The investigational therapy is the subject of an active clinical development program, or an application for marketing authorization has been submitted, and is not approved in any indication in the country concerned
  • An adequate supply of the investigational therapy exists to perform necessary clinical studies as well as to provide expanded access to patients who do not have alternative treatment options, or who are not eligible for enrollment in clinical trials
  • The expanded access does not interfere with or compromise the clinical development or regulatory approval of the drug under investigation
  • There are sufficient clinical data available with respect to both the investigational therapy and the disease condition for which the application is being sought, to anticipate that any potential benefits from treatment are likely to outweigh any potential risks to the individual seeking treatment.

Statement On Expanded Access/Special Access For ATH434

At this time, Alterity believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. ATH434 has not been approved for use in any country and is not available under any Expanded Access Program/Special Access Scheme. Alterity continues to assess the eligibility requirements and criteria for expanded access to ATH434 and will re-evaluate this policy from time to time.

Learn More

If you are an individual who is interested in accessing our investigational drugs, please speak with your physician. You may learn more about our ongoing clinical trials by going to www.clinicaltrials.gov and searching for ATH434.

If you are a physician who is interested in learning more about our investigational therapies or participating in our clinical trials, please submit a request to clinicaltrials@alteritytherapeutics.com. We endeavor to respond to all enquiries sent to this email within five business days.