Diseases that affect mucus membranes, such as those lining the inside of the mouth, can be difficult to treat because drugs don’t adhere well to wet surfaces.
Afyx Therapeutics, a Danish transdermal drug company that established its North America headquarters in San Diego about six months ago, says it has developed a nanofiber-based patch that will improve the way patients with such conditions receive treatment.
Called Rivelin, the drug delivery patch is flexible, adhesive, and dissolves naturally in the mouth. The condition Afyx is targeting first, oral lichen planus (OLP), affects about 2 percent of people in the U.S., most often women over age 50. It is unclear what causes the disease, a chronic inflammatory condition that can result in painful lesions in the mouth.
Standard treatment consists of corticosteroids applied topically, in the form of a mouthwash, gel or ointment. Afyx developed its patch to improve on this form of treatment. The company said more direct delivery of corticosteroids will be more efficient, allowing a lower dose to be used, and reduce damage to surrounding tissues.
Afyx was previously called Dermtreat. Jens Hansen, who is best known for developing the Nicorette smoking-cessation patch, started the company in 2014. In 2017 Dermtreat raised $17.7 million in a Series A financing round led by Sofinnova Ventures. Lundbeckfonden Emerge, Novo Seeds, and Welfare Tech Invest also invested.
Nishan de Silva (pictured) was tapped to lead the company in April of this year, at the same time Dermtreat said it was opening operations in San Diego as part of its plan to commercialize Rivelin in the U.S. Hansen became president of research and development and has remained in Denmark overseeing Dermtreat operations there. The company is also putting the patch through clinical trials in Europe, where it was developed.
Previously de Silva was president of San Diego-based Poseida Therapeutics, which is developing a drug to treat multiple myeloma. Prior to Poseida, de Silva was chief financial officer at Ligand Pharmaceuticals, another San Diego biopharma.
The new Afyx name was first announced Thursday.
The patches are made by electrospinning, which forms the tiny fibers that make up the product. Spanish company Bioinicia, which says it operates the world’s first manufacturing facility approved to use the technology to make pharmaceutical products, will make the patches.
Afyx said its Phase 1b study demonstrated that the patch adhered easily to lesions inside the mouth in 13 patients. It also said it had preclinical data showing the patch could be used to deliver clobetasol, a topical steroid, without causing tissue damage. The company is now enrolling patients in a Phase 2b study of the patch as a delivery method for clobetasol to patients with OLP. The company is also studying how to treat other mucosal disorders using the patch.
Afyx plans to present its data this week at a meeting of the European Association of Oral Medicine in Sweden.
Photo courtesy of Afyx Therapeutics