Gemini Therapeutics is a clinical-stage precision medicine company developing novel therapeutic compounds to treat genetically defined, dry AMD. Gemini is also advancing GEM103 as add-on therapy in patients suffering from wet AMD who have been treated with anti-VEGF therapy. Our lead candidate, GEM103, is a recombinant form of the CFH and is designed to address both complement hyperactivity and restore retinal health.
We believe that the most effective way of achieving our goals is through establishing the benefit/risk profile of our investigational products through adequate and well-controlled clinical trials, followed by regulatory approval and commercialization. Patients in need of an investigational product that has not yet been approved are therefore encouraged to participate in one of our clinical trials.
Expanded access refers to the use, outside of a clinical trial, of an investigational drug that is intended to diagnose, prevent or treat a serious condition or immediately life-threatening disease and for which no alternative treatments are available. Expanded access use is usually requested by physicians on behalf of their patients for whom participating in a clinical trial is difficult or impractical. Gemini Therapeutics understands the need for expanded access and having an established program for these kinds of requests.
At this time, Gemini Therapeutics believes that participation in one of our clinical trials is the most appropriate way to access our investigational products. If you wish to seek expanded access to one of our therapies, please have your physician contact us with a formal request at email@example.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In evaluating expanded access requests, Gemini Therapeutics generally will consider the following factors:
- The seriousness of the disease for which expanded access is requested and the availability of alternative treatment options, such as approved products, if any, or other products that are recruiting patients for clinical trials
- The evidence of the potential benefit to the patient versus the potential risks to the patient, based on the available safety and efficacy information at the time
- The ability for us and our manufacturers to provide the product on a fair and timely manner to the patient and for our other ongoing programs
- Whether granting expanded access would potentially compromise the scientific validity of our development programs, or interfere with or delay current clinical trials or regulatory filings for the drug
Please keep in mind that, in accordance with law, we have the discretion to grant or deny a request for expanded access. Also, even if we grant expanded access for a particular instance, expanded access use will be subject to FDA review and approval.
Policy updated January 2021. In line with the 21s Century Cures Act, Gemini Therapeutics may revise this policy at any time.