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Aserton Therapeutics is Tennessee USA based company with worldwide commercial rights to a new treatment (AST201) for scleroderma, an autoimmune fibrotic disease. AST201 has been designated by both the FDA and the European Medicines Agency (EMA) as an orphan drug, as a biologic by the FDA, and is the subject of an open IND. In the US and the EU, orphan drug designation allows for extended market exclusivity, a faster development pathway, and smaller studies required for marketing approval.
Aserton also has the rights to ROT1 (Resistance to Oral Tolerance) a SNP that identifies patients that will respond to AST201 and thereby will provide a significant reduction in clinical development costs and risk.
Aserton is seeking to raise $3 M to conduct two additional studies to demonstrate the immunological mechanisms underlying the effect of AST201 and demonstrate the value of ROT1 genotyping for further studies. This development will position AST201 to raise capital for the Pivotal Single Study adequate for AST201 Marketing Approval or to negotiate a licensing agreement with a large pharmaceutical company.