MAT2203 Compassionate Use Statement

One of the Company's lead product candidates is MAT2203, on oral formulation of amphotericin B based on the Company’s proprietary lipid nanocrystal (LNC) platform delivery technology. MAT2203 is currently being investigated in a Phase 2 clinical trial for the treatment of cryptococcal meningitis and is being prepared to enter a Phase 3 clinical trial for the same indication. The Phase 3 clinical trial is intended to provide the basis for a submission for drug approval to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Matinas BioPharma believes that participation in clinical trials is the most appropriate way to investigate MAT2203 because clinical trials are conducted according to current standards of clinical care and in compliance with applicable regulations. The details regarding all ongoing or planned clinical trials, including eligibility requirements, are published in public databases such as

However, we recognize that there may be patients for whom participation in a clinical trial may not be an option. These patients may seek access to investigational drugs prior to regulatory approval through a compassionate use or expanded access program.

Based upon the preliminary safety and efficacy data that has been generated to date in our clinical trials, Matinas would consider a request for a patient with an invasive fungal infection for whom no alternative treatments were available on a case-by-case basis through a limited emergency access program.

Matinas will consider such special use outside of a clinical trial when the following criteria are met:

  • The patient has a serious or life-threatening disease
  • There is an unmet medical need, or the patient has exhausted all available therapies used to treat the disease
  • The patient is not eligible or cannot participate in an ongoing clinical trial
  • There is sufficient scientific evidence that the potential patient benefit justifies the potential risks of treatment
  • This compassionate use will not interfere with clinical trials or other development efforts that could support the approval of the investigational product by a health authority
  • There are sufficient clinical data about use of the investigational product to identify an appropriate dosing regimen and that the available formulation is suitable
  • There is sufficient supply to support both the ongoing and planned clinical trials and prior approved compassionate use requests
  • All treating healthcare providers who submit compassionate use or expanded access requests on behalf of patients must be licensed and qualified to administer the investigational medicine. The healthcare provider must comply with local laws and regulatory requirements and agree to obtain all regulatory/ethics approvals and patient informed consent; s/he is willing to conduct all necessary medical monitoring, safety reporting, and data collection.

This policy may be reviewed and amended in the future. For additional information about this policy, please contact us at