Clinical Trials

We’re currently advancing four clinical-stage programs designed to improve patient outcomes across multiple areas of unmet need.

Sickle Cell Disease

We’re currently enrolling adults and adolescents with sickle cell disease into the Hibiscus Study, a registrational Phase 2/3 randomized, placebo-controlled, double-blind, multicenter trial to further evaluate the safety and efficacy of etavopivat. For more information, visit ClinicalTrials.gov/NCT04624659 or www.HibiscusStudy.com. For more information about the Phase 1 trial, visit ClinicalTrials.gov/NCT03815695.

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Acute Myeloid Leukemia

In an ongoing Phase 2 trial, olutasidenib yielded positive study results in patients with relapsed/refractory AML. We have exclusively licensed olutasidenib to Rigel Pharmaceuticals to develop, manufacture and commercialize for any uses worldwide, including for the treatment of R/R AML. We will continue to progress the NDA filing of olutasidenib and the completion of the registrational study. The key objectives of the registrational Phase 1/2 trial are to evaluate the safety, efficacy and pharmacokinetics and pharmacodynamics of olutasidenib as a single agent or in combination with azacitidine.

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Glioma

Olutasidenib, also referred to as FT-2102, is currently being evaluated in an exploratory Phase 1 trial for glioma. The key objectives of this open-label trial are to evaluate the safety, pharmacokinetics and pharmacodynamics of olutasidenib as a single agent in this patient population.

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About Clinical Trials

Clinical trials are research studies to evaluate whether new drugs or treatments are both safe and effective. Trials are a keystone of medical advancement. They provide important information on the benefits, side effects and possible uses for medicines. In cancer research, clinical trials often evaluate the use of a combination of therapies.

Clinical trials answer important questions about potential new treatments and approaches, such as:

  1. Does the treatment work?
  2. Does it work better than current treatment options?
  3. What side effects does it cause?
  4. Do the treatment benefits outweigh the side effects and risks?

Health regulatory agencies, such as the U.S. Food and Drug Administration (FDA), review findings from clinical trials as part of the process to determine if an investigational therapy or new combination regimen should be approved for use.

As a patient, why should I participate in a clinical trial?

Participating in a clinical trial is a voluntary opportunity for you to play an active role in your own health care. If you are considering enrolling in a clinical trial, it’s important to consult with your healthcare provider/practitioner beforehand. You can always leave a clinical trial at any time.

How do I participate in a clinical trial?

The National Institutes of Health (NIH) maintains a database of all clinical trials being conducted in the U.S. You can search the database here to find trials that are enrolling and results from trials that have been completed. It is recommended you involve your healthcare provider/practitioner in your decision and during your participation.

Forma’s Expanded Access Policy

Forma is committed to creating medicines in therapeutic areas for people with serious diseases who may benefit from new treatment options. Our investigational drug candidates continue to be tested to determine whether they are safe and effective. This means that the FDA has not yet approved these investigational drugs nor found them to be safe and effective for their specific use. Clinical trials are the research studies designed to evaluate whether investigational drugs are safe and effective. We encourage patients to speak with their physicians about their eligibility for enrollment in any of Forma’s clinical trials.

We recognize that patients and their physicians may believe that a patient with a serious or immediately life-threatening disease could benefit from Forma’s investigational drugs, even if the patient does not qualify for participation in one of Forma’s clinical trials. Under these circumstances, access may sometimes be provided through a “compassionate use” program, also known as “expanded access” in the United States.

Forma’s investigational drugs are currently at a stage in development where we are focused on enrolling in our clinical studies, and continuing to learn more about our investigational drugs’ safety and efficacy. At this time, we are not yet supporting expanded access requests for newly treated patients.* As we continue to develop our clinical pipeline, we encourage you to check back on our website for updates regarding investigational drugs which may later be available through expanded access.

For more information, please contact medicalinformation@formatherapeutics.com.

Learn about the FDA’s position on expanded access here.

* Such requests include requests under 561(b) of the Federal Food, Drug and Cosmetic Act and also “Right to Try” legislation.