Painful ulcers with lifelong prevalence
Recurrent Aphthous Ulcers (RAS) is the most common condition affecting the oral mucosa in the population. The major problem experienced by patients is moderate to severe pain, especially during eating and talking. Disease cause(s) is still unknown. The yearly prevalence of RAS is approximately 1.5 percent of the adult population worldwide. Lifelong prevalence in the population is approximately 40 percent. Depending on market activities and product acceptance, the product can theoretically reach a target patient population of 10-20,000 patients annually in Sweden, and considerably higher in international markets.
Rapid pain relief with a patented oral patch
We are developing an oral patch, which will be a patented galenic formulation, providing rapid pain relief for the patient. This unique preparation will be documented in an appropriate phase IIa clinical study. Exit planning will be instituted early, and potential partners will identified for further commercial and market exploitation.
New way to adress condition compared to previous solutions
In contrast to current solutions, our strategy is to use the positive effect of a covering patch / gel in a unique galenic formulation which will provide rapid pain relief. Within the project partner group, we have a unique competence in oral medicine, clinical pharmacology, endocrinology, innovation management, patient recruitment, galenic pharmacies, project and process development, as well as marketing and sales.
The Mucocort solution has solid scientific backing
There are several potential products on the market for OTC use. Such options include aloe vera, biologics, gamma globulin treatment, sodium chromoglycate lozenges, dapson, colchicine, pentoxifyllin, levamisol, colchicine, azathioprine, prednisolone, azelastin, alpha 2-interferon, cyclosporin, deglycerated licorice, 5-amino salicylic acid (5-ASA), prostaglandin E2 (PGE2), sucralfate, diclofenac and aspirin.
Apart from potent steroids, which cause problematic side effects, none of these drugs are accepted by the medical community as being consistently beneficial in the treatment of RAS. This is supported by a Cochrane review (2012) of treatments for aphthous stomatitis, which found that data from all major attempts lacked methodological rigor and concluded that no single therapy could be recommended given the data currently available.
We have established an innovation company (Mucocort AB) with multiple competences relevant to RAS. An IP / IA strategy is formulated and under development. Planning of process work, galenic development and clinical trials according to ISO 13485 is ongoing.