The race to replace anti-TNF injectables in ulcerative colitis has just seen a new participant in Sublimity Therapeutics, powered with $64 million it just raised from Orbimed and Longitude Capital.
At the center of attention is STI-0529, an oral formulation of drug called cyclosporine, which is approved for several inflammatory diseases including rheumatoid arthritis and psoriasis (and often used off-label for Crohn’s disease). The new funds will fuel a Phase IIb study evaluating the drug’s safety and efficacy in patients with moderate to severe ulcerative colitis.
Alongside the money, Sublimity has also ushered in a a few top executives, appointing Anthony Giovinazzo the executive chairman, Albert Agro the CEO and Andrew Williams the new CFO. The trio had worked together at Cynapsus Therapeutics until Sunovion Pharma acquired the company and its Parkinson’s disease drug in 2016.
They will now join a group of biotechs working to overcome toxicity and resistance issues troubling traditional anti-TNF treatments. It’s a multibillion dollar vision that J&J has bought into through a $1 billion deal with Theravance, and recent PhII data from Israel’s Protalix offer some early evidence of efficacy for its oral drug without triggering the formation of anti-drug antibodies.
“The early data from JAK and S1P Inhibitors investigated for this indication are intriguing; however, we and our investors believe the evidence supporting STI-0529 are just as if not more compelling and we are excited about moving the Phase 2b program into the clinic as soon as possible,” Agro said in a statement.
Sublimity will now continue to plan the Phase IIb study with the help of its partners at Dr. Falk Pharma, a German gastrointestinal disease-focused company that had taken an upfront equity investment in Sublimity and pledged to co-fund development.
STI-0529, which is formulated to bypass absorption in the upper GI tract and target only the site of the diseased tissue in the colon, has gone through a PhIIa study demonstrating safety and tolerability.
David Bonita of OrbiMed and Josh Richardson of Longitude Capital are joining the board of directors together with Alexander Asam of HBM Healthcare Investments, which also got involved in the round.
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