Expanded Access

Technophage is an innovative clinical-stage biopharmaceutical company committed to the R&D and manufacturing of new biological molecules in several therapeutic areas. The company develops innovative products based on three different technological platforms providing solutions to answer different clinical needs in the fields of infection, neuroscience, ophthalmology and, more recently, oncology.

Technophage is focused on increasing its pipeline of proprietary technologies and deriving products to help patients in the near future. Consistent with Technophage’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies (ClinicalTrials.gov Identifier: NCT04803708). We believe this approach will serve patients who could be helped by the therapies we are developing.

At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, and after conclusion of Phase I/IIa clinical trial that will allow us to get preliminary safety data, Technophage will consider providing a requesting physician with pre-approval access to TP-102, an investigational drug applied topically for the treatment of diabetic foot infections by Staphylococcus aureus, Pseudomonas aeruginosa and/or Acinetobacter baumannii, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.

These conditions include the following:

  • The patient has a serious or life-threatening illness or condition related to a chronic non healing infected wound and is either no longer responsive to or no longer able to tolerate any available treatment option;
  • The investigational drug is in active clinical development with limited data available to advice on an appropriate dose and schedule for the patient’s specific condition;
  • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
  • Access to TP-102 is in accordance with the laws and regulations effective in the country in which the product will be administered;
  • Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
  • Adequate supply of the investigational drug is available.

 

We continually evaluate the benefit-risk profile of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Technophage is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Technophage may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Technophage whose decisions are final.

Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Susana Gonçalves through expandedaccess@technophage.pt. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days after receipt.

These requests may also be submitted through the form below.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.