In short
SPY001-001 is an investigational long-acting antibody being studied for moderately to severely active ulcerative colitis, a form of inflammatory bowel disease. It is currently in Phase 2 trials, including one study with 650 participants evaluating its effect on histologic disease activity and clinical remission at Week 12. A second Phase 2 trial with 645 participants is assessing long-term safety and tolerability. SPY001-001 is given by subcutaneous or intravenous administration.
Key points
- SPY001-001 is an investigational long-acting antibody for ulcerative colitis.
- It is being tested in Phase 2 clinical trials.
- One trial with 650 participants measures histologic improvement and clinical remission at 12 weeks.
- A second trial with 645 participants focuses on long-term safety and side effects.
- The antibody is given by subcutaneous injection or intravenous infusion.
- Both trials are currently authorised, meaning they are approved to run but may not yet be recruiting.
What is SPY001-001?
SPY001-001 is an investigational long-acting antibody. It is not yet an authorised medicine; it is being studied in clinical trials. The full name "SPY001-001" is a development code, and no trade name has been given in the registry records. It is being investigated for the treatment of moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine.
How does SPY001-001 work?
The registry records describe SPY001-001 as a long-acting antibody, but they do not provide details about its molecular target or mechanism of action. Antibodies are proteins that can bind to specific molecules in the body, and long-acting antibodies are designed to remain active for an extended period after administration. The exact way SPY001-001 affects ulcerative colitis is not described in the available trial data.
Which conditions is SPY001-001 being studied for?
- Moderately to severely active ulcerative colitis — a form of inflammatory bowel disease that causes inflammation and ulcers in the colon, leading to symptoms such as diarrhoea, abdominal pain, and rectal bleeding.
- Ulcerative colitis (inflammatory bowel disease) — the same condition is listed in the long-term safety trial, including participants with ulcerative colitis as part of the broader inflammatory bowel disease category.
How is SPY001-001 given?
SPY001-001 is administered by subcutaneous injection, meaning it is injected under the skin, or by intravenous administration, meaning it is given directly into a vein. Both routes are listed in the trial records. The concentration is recorded as 0 mg/ml in the registry, which indicates that the specific dose was not reported in the public record.
What do the clinical trials show?
Two Phase 2 trials are registered for SPY001-001, both currently with the status "Authorised," meaning they have received regulatory approval to proceed but may not yet be actively recruiting participants. Both trials investigate SPY001-001 alone and in combination with other long-acting antibodies (SPY002 and SPY003).
What are the trials measuring?
The first trial (NCT07012395) has two parts. Part A measures the change in RHI — the Robarts Histopathology Index, a scoring system that assesses microscopic inflammation in intestinal tissue — from baseline at Week 12. Part B measures clinical remission at Week 12, meaning the proportion of participants whose symptoms have substantially or completely resolved. The second trial (2025-524640-35-00) measures the incidence of treatment-emergent adverse events (TEAEs) — side effects that appear or worsen after starting treatment — as its primary outcome, focusing on long-term safety and tolerability.
Who can take part in these trials?
The first trial is for people with moderately to severely active ulcerative colitis. The second trial includes participants with ulcerative colitis as part of inflammatory bowel disease. The registry records do not provide detailed inclusion or exclusion criteria such as age limits, prior treatments, or specific disease duration.
What phases and status do the trials have?
Both trials are Phase 2 studies. Phase 2 trials test a treatment in a larger group of people than Phase 1 to evaluate effectiveness and further assess safety. The first trial has 650 participants enrolled, and the second has 645 participants. Both are listed as "Authorised," meaning they have been approved by regulators but may not yet have started recruiting.
What side effects are known?
The trial records do not report specific side effects for SPY001-001. The long-term safety trial is designed to measure treatment-emergent adverse events, but no results or specific side effect data are provided in the registry records at this time.