To test the hypothesis of the SPY772 program, the company also announced the initiation of SKYLIGHT, a randomized Phase 2 proof-of-concept trial evaluating dual inhibition of TL1A and IL-17A/F in Hidradenitis Suppurativa (HS).
"Combination therapy has demonstrated the ability to meaningfully improve efficacy without apparent safety downsides in multiple autoimmune conditions. We believe our differentiated strategy of developing long-acting antibody coformulations against validated targets appears increasingly likely to deliver indication-leading product profiles," said Sheldon Sloan, M.D., Chief Medical Officer. "Expanding our portfolio to include long-acting IL-17A/F broadens the potential for our pipeline to improve outcomes across some of the largest gastrointestinal, dermatologic, and rheumatic diseases with substantial remaining unmet medical need."
"HS is a chronic, painful disease that can profoundly affect patients' quality of life, and many patients do not achieve adequate disease control with available therapies. We believe targeting complementary inflammatory pathways has the potential to raise the efficacy ceiling in HS," said Josh Friedman, M.D., Ph.D., SVP of Clinical Development and SKYLIGHT study lead. "SKYLIGHT will evaluate whether adding SPY072 (anti-TL1A) to bimekizumab (anti-IL-17A/F) can improve outcomes beyond bimekizumab alone. Positive SKYLIGHT results would support advancement of our long-acting SPY772 combination (SPY072 and SPY007) in HS. We are also excited to potentially explore other indications with this combination pending our SKYWAY trial results."
SKYLIGHT is a randomized, placebo-controlled Phase 2 proof-of-concept study expected to enroll approximately 150 adults with moderate-to-severe HS. Participants will receive background bimekizumab therapy and either SPY072 or placebo. The primary endpoint is the proportion of patients achieving a HiSCR75 response at Week 16. Topline results are expected in late 2027 or early 2028.
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