SwanBio is deeply committed to the AMN community and is continuing to work closely with patients, family members, and expert physicians to ensure that our clinical programs are designed to meet their needs.
We are pleased to announce that our first-in-human study, PROPEL, is now enrolling! PROPEL is a Phase 1/2 clinical study designed to assess the safety of SBT101, a novel, investigational gene therapy intended to treat AMN. The study will also explore how SBT101 may affect the progression of the disease.
A Natural History Study of Adult Men with AMN
With patients at the forefront of all that we do, SwanBio is conducting research to deepen our understanding of AMN and gather insights that may help inform the clinical programs for our investigational therapies. Understanding the experiences of people living with certain diseases is an important part of the drug development process.
CYGNET is our prospective, retrospective, multicenter, multinational natural history study of AMN in adults with inherited forms of spastic paraplegia. This global study will help us understand and document the natural history (or progression without treatment) of AMN, by collecting information from enrolled patients’ medical histories, as well as following those same patients forward over time.
Learn more about enrollment in the CYGNET study.
Clinical trials are designed to collect information about the potential risks and benefits of investigational drugs.
If data from these studies provide sufficient evidence of safety and efficacy, we will approach regulatory authorities like the U.S. FDA for approval, with the goal of making our therapies broadly available to patients.
On a case-by-case basis, the FDA and other regulatory authorities in partnership with drug developers may allow patients outside a clinical trial access to investigational drugs before they are officially approved. These exceptions – known as compassionate use or expanded access – may be granted if a patient is suffering from a life-threatening or serious condition, cannot participate in a clinical trial, and there is a reasonable expectation of benefit, among other reasons.1 SwanBio follows the FDA Guidance to assist in decision-making about granting expanded access.
At SwanBio, we lead with passion and a sense of urgency in everything we do – including the research and clinical studies we conduct to better understand how our investigational drugs work.
Information about our open trials and eligibility criteria can be found on www.clinicaltrials.gov. If you are a physician interested in more information related to our ongoing studies or investigational drugs, please contact: email@example.com. A member of our team will respond within five business days. Per the 21st Century Cures Act, SwanBio may revise this policy at any time.