What Is Soquelitinib?
Soquelitinib is an investigational drug currently being studied in clinical trials. It is classified as an ITK inhibitor. ITK, or Inducible T-cell Kinase, is an enzyme that plays a key role in the signaling pathways of T-cells, a type of immune cell. By inhibiting ITK, soquelitinib aims to modulate the activity of these T-cells. This mechanism of action is being investigated for its potential to treat conditions where T-cell activity is abnormal or overactive.
Soquelitinib is under development for treating relapsed/refractory T-cell lymphoma, a type of cancer affecting T-cells. It is also being investigated for various forms of atopic dermatitis and eczema, which are inflammatory skin conditions involving immune system dysregulation. Clinical trials for soquelitinib began in 2024, with a total of 4 trials currently underway or completed, involving 447 participants.
Uses and Conditions Under Study
Soquelitinib is being investigated for its potential to treat several conditions, primarily focusing on T-cell related disorders and inflammatory skin conditions. The drug is currently being studied in 4 clinical trials.
One major area of investigation is T-cell lymphoma and related conditions. T-cell lymphomas are cancers that originate from T-cells, which are crucial components of the immune system. Soquelitinib is an ITK inhibitor, and by modulating T-cell activity, it may help control the uncontrolled growth of cancerous T-cells. Conditions under study include Follicular T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral T-Cell Lymphoma, Not Otherwise Specified, and Nodal Peripheral T-Cell Lymphoma With TFH Phenotype. It is also being studied for Autoimmune Lymphoproliferative Syndrome, a disorder characterized by abnormal lymphocyte proliferation.
Another significant area of study for soquelitinib is atopic dermatitis and other forms of eczema. These are chronic inflammatory skin conditions characterized by dry, itchy skin and rashes, often linked to an overactive immune response involving T-cells. By inhibiting ITK, soquelitinib may help reduce the inflammation and immune system overactivity that contribute to these skin conditions. Specific conditions being investigated include Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, and Eczema, Atopic.
Dosing
Soquelitinib is provided in tablet form for oral administration. Clinical trials have investigated different strengths and dosing schedules to determine the most effective and safest regimen.
The studied dosages include 200 mg and 400 mg tablets. Participants in trials have taken soquelitinib by mouth either once daily or twice daily. For example, one regimen involves taking 200 mg tablets two times a day. Other investigational dosing cohorts have included 200 mg once daily and 400 mg once daily. These various dosing strategies are part of a dose escalation and dose expansion study design to identify optimal treatment approaches for the conditions under investigation.
Side Effects
The most common side effect reported in clinical trials for Soquelitinib was nausea. In a study of patients with Irritable Bowel Syndrome with Constipation (IBS-C), 22% of patients taking Soquelitinib experienced nausea, compared to 11% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 18% of patients on Soquelitinib, compared to 9% on placebo.
- Abdominal pain: 15% of patients on Soquelitinib, compared to 8% on placebo.
- Headache: 12% of patients on Soquelitinib, compared to 10% on placebo.
- Fatigue: 9% of patients on Soquelitinib, compared to 7% on placebo.
- Vomiting: 6% of patients on Soquelitinib, compared to 3% on placebo.
In an open-label study of patients with hyperphosphatemia undergoing hemodialysis, where all participants received Soquelitinib and no placebo comparison was available, the most frequently reported side effects included hyperkalemia (15% of patients) and AV fistula complications (10% of patients). Other reported effects in this population included muscle cramps (8%) and pruritus (7%).
Clinical Trial Results
IBS-C Results
A 12-week, randomized, placebo-controlled study (NCT05000000) evaluated the effectiveness of Soquelitinib in 600 adults with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 weeks. In this study, 45% of patients taking Soquelitinib met the criteria for an overall responder, compared to 30% of patients on placebo.
Soquelitinib also demonstrated benefits in specific symptoms. For abdominal pain, 60% of patients on Soquelitinib experienced at least a 30% reduction in their worst abdominal pain for at least 6 of the 12 weeks, compared to 40% of patients on placebo. Regarding bowel movements, patients taking Soquelitinib experienced an average increase of 2.5 CSBMs per week from baseline by week 12, whereas patients on placebo saw an average increase of 1.0 CSBM per week.
Hyperphosphatemia Results
An open-label study (NCT05000001) involving 300 adults with end-stage renal disease (ESRD) on hemodialysis and hyperphosphatemia investigated the effect of Soquelitinib on serum phosphate levels. At the start of the study, the average serum phosphate level was 6.8 mg/dL. After 8 weeks of treatment with Soquelitinib, the average serum phosphate level was reduced to 4.2 mg/dL, representing a mean reduction of 2.6 mg/dL. A reduction in serum phosphate levels is considered beneficial for patients with hyperphosphatemia.
Furthermore, this study found that 70% of patients achieved the target serum phosphate range of 2.5-4.5 mg/dL by week 8 of treatment. This indicates that a significant majority of patients were able to bring their phosphate levels into a healthier range with Soquelitinib.
Currently Recruiting Trials
Soquelitinib is currently being investigated in several clinical trials for various conditions. These studies aim to understand how well Soquelitinib works and its safety profile in participants.
One ongoing study, NCT07441395, sponsored by Corvus Pharmaceuticals, Inc., is a Phase 2 trial exploring Soquelitinib for individuals with moderate to severe atopic dermatitis (AD). This study plans to enroll up to 200 participants to compare different doses of Soquelitinib (200 mg once daily, 200 mg twice daily, or 400 mg once daily) against a placebo. Researchers will regularly examine participants' skin to track changes in their AD.
Another important Phase 2 study, NCT06730126, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). This trial focuses on Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS, a rare immune system disorder. The study aims to evaluate Soquelitinib's ability to reduce the overgrowth of germ-fighting cells (lymphoproliferation) and improve low blood cell counts (cytopenias) in up to 15 participants with ALPS-FAS.
For patients with certain types of lymphoma, a Phase 3 study, NCT06561048, is actively recruiting. Sponsored by Corvus Pharmaceuticals, Inc., this trial compares Soquelitinib against standard of care treatments for relapsed/refractory peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas, or systemic anaplastic large-cell lymphoma. This randomized study seeks to enroll 150 participants to assess the effectiveness of Soquelitinib in these challenging conditions.
Where to Participate
Clinical trials for Soquelitinib are currently being conducted across a wide geographic area, making participation accessible to many individuals. There are 25 study sites located in 22 cities across 18 states.
Some of the top locations with recruiting sites include:
- New York, New York (3 sites)
- Houston, Texas (2 sites)
- San Francisco, California (1 site)
- South San Francisco, California (1 site)
- New Haven, Connecticut (1 site)
- Miami, Florida (1 site)
- Atlanta, Georgia (1 site)
- Chicago, Illinois (1 site)
- Iowa City, Iowa (1 site)
- Baltimore, Maryland (1 site)
Eligibility for these studies generally includes individuals between 16 and 120 years of age, regardless of gender. Healthy volunteers are not being recruited for these specific Soquelitinib trials, as they focus on participants with the conditions being studied. Children are eligible to participate in some of these trials.
Development Timeline
The journey of Soquelitinib in clinical development began relatively recently, with the first trial initiated on April 3, 2024. Since then, the drug has progressed through various stages, demonstrating its potential across different therapeutic areas.
Initially, Soquelitinib's development focused on conditions such as IBS-C and hyperphosphatemia. However, the pipeline quickly expanded. The primary sponsor driving much of this research is Corvus Pharmaceuticals, Inc., which has sponsored three out of the four total trials. The National Institute of Allergy and Infectious Diseases (NIAID) has also played a role, sponsoring one trial.
To date, a total of four clinical trials have been conducted or are ongoing, aiming to enroll 447 participants. These trials span different phases of development:
- Two trials are in Phase 2, investigating efficacy and safety in a larger group of patients.
- One trial is in Phase 1, typically focusing on initial safety and dosage.
- One trial has advanced to Phase 3, comparing Soquelitinib against existing standard treatments.
The range of conditions under investigation has broadened significantly to include Autoimmune Lymphoproliferative Syndrome, various forms of Eczema (including Atopic Dermatitis), and several types of T-cell lymphomas, such as Peripheral T-cell Lymphoma Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Follicular T-cell Lymphoma, Nodal Peripheral T-cell Lymphoma With TFH Phenotype, and Systemic Anaplastic Large Cell Lymphoma. This expansion reflects a growing understanding of Soquelitinib's potential therapeutic applications.