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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR ABITREXATE


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All Clinical Trials for Abitrexate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003702 ↗ Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Completed Eastern Cooperative Oncology Group Phase 3 1999-06-01 Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗ Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Completed National Cancer Institute (NCI) Phase 3 1999-06-01 Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗ Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Completed Gynecologic Oncology Group Phase 3 1999-06-01 Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Abitrexate

Condition Name

Condition Name for Abitrexate
Intervention Trials
Acute Lymphoblastic Leukemia 26
Leukemia 13
Untreated Adult Acute Lymphoblastic Leukemia 13
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Condition MeSH

Condition MeSH for Abitrexate
Intervention Trials
Leukemia 59
Precursor Cell Lymphoblastic Leukemia-Lymphoma 54
Leukemia, Lymphoid 54
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Clinical Trial Locations for Abitrexate

Trials by Country

Trials by Country for Abitrexate
Location Trials
Canada 142
Australia 61
New Zealand 25
Puerto Rico 14
Japan 8
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Trials by US State

Trials by US State for Abitrexate
Location Trials
Texas 58
Ohio 42
Washington 40
Pennsylvania 40
California 39
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Clinical Trial Progress for Abitrexate

Clinical Trial Phase

Clinical Trial Phase for Abitrexate
Clinical Trial Phase Trials
Phase 3 22
Phase 2/Phase 3 3
Phase 2 49
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Clinical Trial Status

Clinical Trial Status for Abitrexate
Clinical Trial Phase Trials
Recruiting 28
Active, not recruiting 27
Completed 24
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Clinical Trial Sponsors for Abitrexate

Sponsor Name

Sponsor Name for Abitrexate
Sponsor Trials
National Cancer Institute (NCI) 83
M.D. Anderson Cancer Center 24
Children's Oncology Group 19
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Sponsor Type

Sponsor Type for Abitrexate
Sponsor Trials
NIH 88
Other 85
Industry 25
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Clinical Trials, Market Analysis, and Projections for ABX464 (Not Abitrexate)

Introduction to ABX464

ABX464, developed by Abivax, is a novel drug candidate that has shown promising results in treating chronic inflammatory diseases. Unlike the term "Abitrexate," which seems to be a misnomer, ABX464 is the correct designation for this drug.

Current Clinical Trials

Rheumatoid Arthritis

ABX464 has demonstrated excellent safety and efficacy in phase 2a clinical trials for the treatment of rheumatoid arthritis (RA). The study involved 60 patients who had an inadequate response to methotrexate and/or TNFα inhibitors. The primary endpoint of safety and tolerability was met, and the drug showed a statistically significant difference in the key efficacy endpoint ACR20 compared to the placebo group[1].

Ulcerative Colitis

ABX464 is currently in Phase 3 clinical trials (ABTECT-1 and ABTECT-2) for the treatment of moderately to severely active ulcerative colitis (UC). These trials, which started in 2022, aim to evaluate the efficacy and safety of ABX464 for induction treatment. Additionally, a maintenance study (ABTECT MAINTENANCE) is ongoing to assess the long-term efficacy and safety of the drug[5].

Crohn’s Disease

A dose-ranging Phase 2b clinical trial (ENHANCE-CD) in moderately to severely active Crohn’s disease is planned, with patient enrollment expected to start in Q3 2024[5].

Market Analysis

Methotrexate Market Context

To understand the market potential of ABX464, it is helpful to look at the context of the methotrexate market, which is a common treatment for rheumatoid arthritis and other inflammatory diseases. The global methotrexate drugs market was valued at USD 584.09 million in 2024 and is projected to reach USD 846.99 million by 2037, growing at a CAGR of 2.9% during the forecast period[2].

Growing Demand for Inflammatory Disease Treatments

The increasing prevalence of autoimmune diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and lupus is driving the demand for new and effective treatments. Given that about 60% of people with rheumatoid arthritis are currently taking methotrexate, there is a significant market opportunity for alternative treatments like ABX464[2].

Market Projections

Potential Market Size

While specific market projections for ABX464 are not available, the overall chronic inflammation market is estimated to exceed USD 110 billion. Given the encouraging data from clinical trials, ABX464 is poised to capture a significant share of this market, especially if it proves to be a safer and more effective alternative to existing treatments like methotrexate[1].

Regional Growth

The North American market, which is expected to hold a significant revenue share, will be a key region for ABX464. The high adoption of innovative technologies, higher healthcare expenditures, and the immediate availability of pharmacotherapy are factors that will drive growth in this region[2].

Competitive Landscape

The market for inflammatory disease treatments is competitive, with established drugs like methotrexate dominating the scene. However, the success of ABX464 in clinical trials suggests it could carve out a niche by offering better safety and efficacy profiles, which could attract a significant patient population[1].

Expert Insights and Statistics

  • Clinical Trial Success: "ABX464 demonstrated good safety and tolerability profile with 50mg once daily oral administration... A statistically significant difference (p < 0.03) was met on key efficacy endpoint ACR20 in the PP2 population with 60% of ABX464 patients dosed with 50mg reaching that endpoint versus 22% in the placebo group"[1].
  • Market Growth: The global methotrexate injection market, which can serve as a proxy for the broader inflammatory disease treatment market, is expected to grow from USD 527.52 million in 2022 to USD 687.65 million by 2030, at a CAGR of 2.6%[3].

Future Outlook

Additional Indications

Given the demonstrated safety and efficacy of ABX464 in rheumatoid arthritis and ulcerative colitis, Abivax is exploring additional programs in chronic inflammatory indications. This expansion could further increase the market potential of the drug[1].

Regulatory and Clinical Milestones

The initiation of Phase 3 trials in UC and planned Phase 2b trials in Crohn’s disease and RA are critical milestones. Successful outcomes in these trials will be pivotal for regulatory approvals and subsequent market entry[5].

Key Takeaways

  • Clinical Success: ABX464 has shown promising results in clinical trials for rheumatoid arthritis and ulcerative colitis.
  • Market Potential: The drug is poised to capture a significant share of the chronic inflammation market, estimated to exceed USD 110 billion.
  • Regional Growth: North America is expected to be a key region for market growth due to high healthcare expenditures and the adoption of innovative technologies.
  • Competitive Advantage: ABX464’s better safety and efficacy profiles could differentiate it from existing treatments like methotrexate.

FAQs

Q: What is ABX464, and what diseases is it being tested for? A: ABX464 is a novel drug candidate being tested for the treatment of chronic inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, and Crohn’s disease.

Q: What are the key findings from the phase 2a clinical trials of ABX464 in rheumatoid arthritis? A: The trials showed a good safety and tolerability profile, with a statistically significant difference in the key efficacy endpoint ACR20 compared to the placebo group.

Q: What is the current status of ABX464 in clinical trials for ulcerative colitis? A: ABX464 is currently in Phase 3 clinical trials (ABTECT-1 and ABTECT-2) for the treatment of moderately to severely active ulcerative colitis.

Q: How does the market for ABX464 compare to the methotrexate market? A: While ABX464 is a new entrant, the methotrexate market provides a context for its potential. The methotrexate market is projected to grow, indicating a strong demand for inflammatory disease treatments.

Q: What are the future plans for ABX464 in terms of additional indications? A: Abivax is planning to explore additional chronic inflammatory indications based on the encouraging data from current trials.

Sources

  1. Abivax SA, "ABIVAX REPORTS EXCELLENT PHASE 2A CLINICAL SAFETY AND EFFICACY RESULTS WITH 50MG ABX464 IN RHEUMATOID ARTHRITIS," June 23, 2021.
  2. Research Nester, "Methotrexate Drugs Market Size & Share, Forecast Report 2037," November 8, 2024.
  3. Data Bridge Market Research, "Methotrexate Injection Market Size, Value & Opportunities By 2030."
  4. Straits Research, "Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2024-2033," October 22, 2024.
  5. Abivax, "Our Research," accessed January 9, 2025.

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