SynAct Pharma receives favorable US patent decision for immediate-release resomelagon tablet formulation

The decision is an important step in SynAct’s strategy to strengthen the intellectual property protection around resomelagon. The appeal concerned whether it was obvious to formulate resomelagon as an immediate-release tablet designed to dissolve rapidly in acidic gastric conditions and support fast absorption. SynAct argued that this was not routine, given the compound’s known sensitivity under acidic conditions, and the PTAB supported SynAct’s position on obviousness.

“This decision is highly important for SynAct and confirms the scientific and formulation work behind resomelagon. Developing an immediate-release oral tablet formulation of resomelagon has been neither a routine nor an obvious exercise. The PTAB decision supports that position and strengthens our long-term IP strategy for resomelagon,” said Thomas Boesen, Chief Operating Officer of SynAct Pharma.

SynAct has previously announced that the USPTO has issued U.S. patent 12,239,631 covering the crystal form of resomelagon and U.S. patent 12,661,336, which includes patent term adjustment extending the term of that patent until July 2, 2044. The PTAB decision adds another important element to SynAct’s overall intellectual property strategy for resomelagon.

Resomelagon (AP1189) is SynAct’s lead drug candidate and is being developed as an oral, once-daily selective melanocortin agonist across two main development tracks: rheumatoid arthritis (RA) and host-directed therapy in viral infections. In RA, resomelagon is being evaluated as a combination with first-line methotrexate therapy, while in viral infections SynAct is evaluating resomelagon’s potential to resolve excessive inflammation in patients with severe viral disease, including respiratory viral infections and Dengue.