In short
SPY003 is an investigational long-acting antibody being studied for ulcerative colitis, a form of inflammatory bowel disease. It is currently being tested in two Phase 2 trials involving 1,295 participants in total. Both trials are authorised but not yet recruiting, and they evaluate SPY003 alone and in combination with other long-acting antibodies.
Key points
- SPY003 is an investigational long-acting antibody for ulcerative colitis.
- Both registered trials are in Phase 2 and are currently authorised.
- One trial plans to enrol 645 participants, the other 650 participants.
- SPY003 is given by subcutaneous injection or intravenous administration.
- The trials measure treatment-emergent adverse events and clinical remission.
What is SPY003?
SPY003 is an investigational long-acting antibody. It is being developed for the treatment of ulcerative colitis, which is a chronic inflammatory bowel disease affecting the large intestine. SPY003 is not yet an authorised medicine; it is currently being studied in clinical trials. The substance is classified as a protein-based substance. In the registry records, SPY003 appears alongside other investigational antibodies such as SPY001-001 and SPY002, as well as placebo products labelled SPYPBO-101 and SPYPBO-102.
How does SPY003 work?
The registry data do not describe the molecular target or mechanism of action of SPY003. The trials investigate its safety and efficacy as a long-acting antibody, alone and in combination with other long-acting antibodies, in ulcerative colitis.
Which conditions is SPY003 being studied for?
- Ulcerative colitis — a long-term condition where the colon and rectum become inflamed and develop ulcers.
- Moderately to severely active ulcerative colitis — a form of the disease with significant symptoms that has not responded adequately to standard treatment.
How is SPY003 given?
SPY003 is given by injection. In one trial it is administered by subcutaneous injection, and in the other trial both subcutaneous and intravenous administration are listed. The dose is not reported in the registry records.
What do the clinical trials show?
Two Phase 2 trials of SPY003 in ulcerative colitis are registered. Both are authorised but not yet recruiting. The trials investigate SPY003 alone and in combination with other long-acting antibodies.
What are the trials measuring?
The long-term safety trial measures the incidence of treatment-emergent adverse events (TEAEs), which are side effects that appear or worsen after treatment starts. The second trial has two parts: Part A measures the change in the Robarts Histopathology Index (RHI) from baseline at week 12, which is a score of microscopic inflammation in bowel tissue; Part B measures clinical remission at week 12, meaning the symptoms of ulcerative colitis have largely or completely disappeared.
Who can take part in these trials?
Participants are adults with ulcerative colitis. The long-term safety trial includes people with ulcerative colitis who have taken part in earlier studies of these antibodies. The second trial is for people with moderately to severely active ulcerative colitis.