TauTona Group Receives Orphan Disease Designation for Sickle Cell Ulcer Treatment

Changing the Standard of Care for Underserved Patients with Debilitating Wounds

We are excited to share that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to one of our fund’s innovations for the treatment of skin ulcers in patients with sickle cell disease. Our first biopharmaceutical company, Theris Medical, will be commercializing the product.

Sickle cell disease is a genetic red blood cell disorder that affects hemoglobin, the molecule in red blood cells that transports oxygen through the bloodstream. People with this disorder have atypical hemoglobin molecules called hemoglobin S, which can distort red blood cells into a sickle, or crescent, shape. The disease affects approximately 100,000 patients in the US alone.

Of these sickle cell patients, approximately 14,000 are affected by leg ulcers, persistent wounds of the lower legs and ankles, which are extremely painful, difficult to treat, and frequently recurrent. Sickle cell ulcers can take many months to heal and nearly 30 percent relapse within 6–8 months. Because these wounds are known to be incredibly painful, painkillers such as opioids are often prescribed to obtain some relief. These ulcers severely impact the quality of life including ankle mobility, gait, sleep, self-esteem, and social and professional interactions.

“We are excited to receive an orphan designation for treating sickle cell leg ulcers, an extremely painful condition which has no FDA-approved treatments on the market today. At TauTona, one of our critical missions is to solve clinical needs in wound care, and this orphan designation in the US confirms the high unmet medical need for a very underserved population,” said Dr. Geoff Gurtner, co-founder and managing director of TauTona Group.

This is the first biopharmaceutical innovation created by the team at TauTona Group and based upon technology developed over years of research in Dr. Gurtner’s lab at Stanford University. In his research, Dr. Gurtner identified that deferoxamine, a drug sickle cell patients already use intravenously for removing excess iron in the blood could have a favorable effect on healing sickle cell leg ulcers if applied topically. TauTona licensed the technology to transition the novel wound care treatment from the lab to the clinic.

The Orphan Drug Designation program provides orphan status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

To learn more, visit www.tautonagroup.com and www.therismedical.com.