Spyre Drops Its Arthritis Drug Plan After Trial Misses, Pivots To Skin Disease With $400 Million
The biotech will not advance SPY072 in rheumatic disease and is pointing an October offering at a pivotal hidradenitis suppurativa program.
Spyre Therapeutics, a clinical-stage biotech developing long-acting antibodies for inflammatory bowel disease and rheumatic diseases, said Tuesday it will not advance its TL1A antibody SPY072 in rheumatic disease, and that an October offering that raised over $400 million will fund a pivotal skin-disease program instead. The news came with third-quarter results, in which the net loss widened to $96.1 million.
Arthritis trials fall short
SPY072 was well tolerated but missed its main goal in both the psoriatic arthritis and axial spondyloarthritis sub-studies of the SKYWAY trial, the company said in an 8-K filing.
In rheumatoid arthritis, both doses showed statistically significant benefits over placebo on one or more measures. Still, the results did not meet what the company called its internal bar to prioritize advancing the drug there.
The company's conclusion: it does not plan to advance SPY072 in rheumatic diseases.
Money goes to hidradenitis suppurativa
Spyre said the offering will fund a pivotal program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition, with SPY072, which it calls a potential best-in-class TL1A monotherapy. It plans to move that drug into pivotal studies for HS in 2027.
In September the company also started SKYLIGHT, a mid-stage trial in moderately to severely active HS patients who are starting bimekizumab. It serves as a stand-in test for a combination of SPY072 and SPY007, a preclinical anti-IL-17A/F antibody. Week 16 topline results are planned for late 2027 or early 2028.
Cash was $1,071.9 million at September 30. Adding $378.0 million in net proceeds from the October offering and $18.0 million of October at-the-market sales gives pro forma cash of $1,467.9 million, with runway expected into the second half of 2029.
Loss widens as spending doubles
Research and development spending reached $89.2 million, against $45.2 million a year earlier, driven mainly by higher manufacturing and clinical trial costs. General and administrative expense rose to $16.6 million from $11.6 million.
The year-earlier net loss was $11.2 million because other income of $45.7 million, mostly from changes in the fair value of a contingent value right liability, offset much of the operating loss. Other income this quarter was $9.6 million.
Net cash used in operations was $77.5 million.
Bowel disease combinations on track
In the SKYLINE ulcerative colitis trial, SPY003 posted positive Part A results, so all three single-drug candidates have now hit their main goals. Part B, which tests combinations, is enrolling ahead of schedule, and the company is raising its enrollment target.
CEO Cameron Turtle said the combination portion is "enrolling faster than expected." Topline induction results for three combinations are expected in the third quarter of 2027.
Spyre expects SKYLINE Part B combination results in the third quarter of 2027 and SKYLIGHT Week 16 data in late 2027 or early 2028.
Sources
- 8-K Filing — Spyre Therapeutics, Inc. (SYRE) — SEC EDGAR
- Exhibit spyre-20260930xexx991pd.htm — Spyre Therapeutics, Inc. 8-K exhibit — SEC EDGAR
