Spyre Therapeutics to Report Phase 1 Interim Results for SPY002 Anti-TL1A Antibody

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-17

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Spyre Therapeutics announced that it will report interim results from Phase 1 healthy volunteer trials for its SPY002 program, a novel half-life extended anti-TL1A antibody, on June 17, 2025. The company will host a conference call and webcast to discuss the results. SPY002 is being developed for the treatment of Inflammatory Bowel Disease (IBD) and other immune-mediated diseases. Spyre Therapeutics is a clinical-stage biotechnology company focused on next-generation IBD and immune-mediated disease treatments through antibody engineering, dose optimization, and rational therapeutic combinations.

Key Highlights

  • Interim Phase 1 results for SPY002 anti-TL1A antibody will be reported on June 17, 2025.
  • A conference call and webcast will be held to discuss the results.
  • SPY002 is a novel half-life extended antibody targeting TL1A.
  • The drug is being developed for Inflammatory Bowel Disease (IBD) and other immune-mediated diseases.

Incidence and Prevalence

The most recent estimates on the global incidence and prevalence of Inflammatory Bowel Disease (IBD) come from the Global Burden of Disease (GBD) 2021 study, as reported in a publication from 2023.

In 2021, there were 375,140 new cases of IBD globally, with a total of 3.83 million cases. While the overall global burden of IBD appears to have decreased, the incidence rate is rising in female patients (APC: +0.06%) and the elderly (APC: +0.14%). The incidence rate remained stable in male patients and the overall population. 11% of new IBD cases were in the elderly.

It's important to note that previous estimates from the GBD 2019 study indicated slightly higher numbers. For example, several publications using the 2019 data reported approximately 4.9 million cases globally in 2019. These studies also highlighted key epidemiological trends:

  • Decreasing global age-standardized rates: Between 1990 and 2019, the global age-standardized rates of prevalence, deaths, and DALYs (disability-adjusted life-years) related to IBD decreased. However, the age-standardized prevalence increased in 13 out of 21 GBD regions and 147 out of 204 countries or territories.
  • Regional variation: North America consistently showed the highest age-standardized prevalence and incidence rates. Oceania had the lowest rates in the 2019 estimates, contrasting with earlier reports that placed the Caribbean as the lowest.
  • Socio-demographic index (SDI) correlation: High SDI locations had the highest age-standardized prevalence, although rates declined from 1990 to 2019. Conversely, middle, low-middle, and low SDI regions saw increases in age-standardized prevalence and incidence over the three decades.
  • Gender differences: IBD prevalent cases, deaths, and DALYs were higher among females than males from 1990 to 2019.

While the GBD 2021 data provides the most recent global figures, it's crucial to consider the trends and regional variations highlighted by the GBD 2019 data to understand the full picture of IBD epidemiology. The observed shifts in incidence and prevalence across different regions and demographics underscore the need for ongoing monitoring and targeted public health interventions.

Economic Burden

Inflammatory Bowel Disease (IBD), encompassing Crohn's disease and ulcerative colitis, poses a substantial economic burden in both the USA and Europe. Quantifying this burden is complex, with variations arising from data sources, methodologies, and the specific cost components considered (direct medical, indirect, and out-of-pocket expenses).

USA:

  • Annual Direct and Indirect Costs: A 2019 study using the Optum Research Database (2007-2016) found that IBD patients incurred three times higher direct costs than non-IBD controls ($22,987 vs. $6,956 per member per year). Out-of-pocket costs were also more than double ($2,213 vs. $979 per year). The first year after diagnosis saw the highest costs (mean $26,555). Key cost drivers included biologics, opioids, steroids, emergency department visits, and services related to relapsing disease, anemia, and mental health comorbidity. Another study linking patient-reported data with claims (2015-2018) found annual direct costs ranging from $7,824 to $41,829. Outpatient costs comprised 19-45% of direct costs, inpatient costs 27-36%, and pharmacy costs 7-51%.
  • Lifetime Costs: A 2019 Markov model analysis estimated lifetime costs based on age at diagnosis. For Crohn's disease, the average lifetime incremental cost was $416,352, with a total lifetime cost of $622,056. For ulcerative colitis, the average lifetime incremental cost was $230,102, with a total lifetime cost of $405,496. The highest lifetime costs were observed in those diagnosed between 0-11 years old ($707,711 for CD and $369,955 for UC).
  • Overall Burden: Estimates from 2014 placed the combined direct and indirect costs of IBD in the US between $14.6 and $31.6 billion. More recent estimates are difficult to pinpoint due to evolving treatment patterns and data limitations.

Europe:

  • Annual Costs: A 2019 study of a pan-European cohort (Epi-IBD) found the mean direct cost per patient-year to be 2,609 (median 446). Costs were highest in the first year, with hospitalizations and diagnostics accounting for over 50%. Biological therapy costs increased over time, reaching 73% of total costs for Crohn's disease and 48% for ulcerative colitis by year 5. The mean annual cost for biologics was 866.
  • Overall Burden: A 2013 review estimated the direct healthcare cost of IBD in Europe to be 4.6-5.6 billion Euros annually. A later review (2020) cited direct healthcare costs of approximately 3,500 for Crohn's disease and 2,000 for ulcerative colitis per patient per year, with indirect costs from work productivity loss around 1,900 per patient yearly.

Key Considerations:

  • Data Variability: Cost estimates vary widely depending on the data source and methodology. Studies using claims data may underestimate true costs, while those relying on patient-reported data may be subject to recall bias.
  • Indirect Costs: Indirect costs, such as lost productivity, are often difficult to quantify but represent a significant component of the overall economic burden.
  • Evolving Treatment Landscape: The introduction of new therapies, particularly biologics, has shifted the cost landscape, with pharmaceutical costs becoming a larger driver.
  • Need for Standardized Measures: Standardized measures and data collection methods are needed to facilitate more accurate comparisons and track the impact of interventions aimed at reducing the economic burden of IBD.

Drug used in other indications

I am sorry, but the provided medical texts do not contain any information about a drug called SPY002 or its clinical trials for any indication, including Inflammatory Bowel Disease (IBD). Therefore, I cannot answer your question about its other trial indications or intervention models.

The texts discuss various treatments for IBD, including:

  • Anti-TNFα agents: These have revolutionized IBD management but can also provoke new autoimmune diseases like Crohn's disease and ulcerative colitis. Etanercept, in particular, showed an increased risk of these conditions in patients treated for other autoimmune diseases.
  • Other biologics: Including vedolizumab (anti-α4β7 integrin), ustekinumab (anti-IL-12/23), and natalizumab (anti-α4). These target different inflammatory pathways and are used when patients don't respond to or can't tolerate anti-TNF agents.
  • Small molecule drugs: Such as tofacitinib and JAK inhibitors, offer alternative mechanisms of action for refractory IBD.
  • Emerging therapies: Including selective JAK inhibitors, IL-23p19 inhibitors, S1P receptor modulators, and anti-lymphocyte trafficking agents. These are showing promise in clinical trials.
  • Combination therapies: Using two biologics or a biologic with tofacitinib is being explored for refractory IBD, but more research is needed.
  • Other approaches: Probiotics, synbiotics, fecal microbiota transplantation, and dietary modifications like the specific carbohydrate diet are also being investigated.

If you can provide more information about SPY002 or its trials, I may be able to assist you further.