What Is REGN7508?
REGN7508 is an investigational drug currently being studied in clinical trials. The specific mechanism of action for REGN7508 is not detailed in the available trial descriptions. It is being investigated for its potential role in treating various conditions, including Atrial Fibrillation (AF), Venous Thromboembolism (VTE), Peripheral Artery Disease (PAD), and Cancer-Associated Thrombosis (CAT). It is also being studied in healthy volunteers to understand its effects and safety profile. The first clinical trial for REGN7508 began on November 2, 2022, with the latest trial expected to conclude by March 25, 2026. To date, 11 clinical trials involving REGN7508 have been initiated, with a total enrollment of 18,276 participants. Of these, 7 trials are currently recruiting participants, while 4 trials have been completed. All clinical trials for REGN7508 are sponsored by Regeneron Pharmaceuticals.
Uses and Conditions Under Study
REGN7508 is being investigated across several different medical conditions, as well as in healthy individuals to understand its basic effects.
- Atrial Fibrillation (AF): Atrial fibrillation is a common type of irregular heartbeat that can increase the risk of stroke. REGN7508 is being studied in 2 trials to determine if it can help manage AF or prevent associated complications.
- Venous Thromboembolism (VTE): This category includes conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE), where blood clots form in veins. REGN7508 is being investigated in 5 trials for its potential to treat or prevent VTE, including symptomatic VTE. This suggests a focus on its anticoagulant or anti-thrombotic properties.
- Peripheral Artery Disease (PAD): PAD occurs when narrowed arteries reduce blood flow to the limbs, most commonly the legs. A single trial is exploring REGN7508's role in PAD, potentially looking at its effects on blood flow or clot prevention in this condition.
- Cancer-Associated Thrombosis (CAT): Patients with cancer have an increased risk of developing blood clots, known as cancer-associated thrombosis. REGN7508 is being studied in 1 trial to assess its effectiveness in managing CAT, a significant complication for cancer patients.
- Healthy Volunteers: REGN7508 is also being administered to healthy volunteers in 2 trials. These studies are crucial for understanding the drug's safety, how it is absorbed, distributed, metabolized, and excreted by the body, and its general effects before it is widely used in patient populations.
Dosing
REGN7508 is being investigated in various dosage forms and strengths within clinical trials. The data indicates that REGN7508 is administered both intravenously (IV) and subcutaneously (SC).
Studies are exploring a range of doses for REGN7508. For intravenous administration, cohorts have been established to evaluate doses from the lowest IV dose up to a higher IV dose. Similarly, for subcutaneous administration, cohorts are investigating doses from a high SC dose to a higher SC dose, with optional cohorts exploring the highest IV or SC dose. These various dose levels are designed to determine the optimal therapeutic and safest concentrations of the drug.
In some trials, REGN7508 is being compared with other medications or placebos. These comparators include apixaban, enoxaparin, aspirin (ASA), and rivaroxaban. Some study arms involve REGN7508 alone, REGN7508 combined with placebo, or REGN7508 in combination with aspirin. Another investigational compound, REGN9933, is also being studied, sometimes alongside REGN7508 or aspirin. The specific doses and administration schedules (e.g., once daily, twice daily) for REGN7508 are determined by the protocol of each individual clinical trial and are not detailed in this summary.
Side Effects
In a clinical trial (NCT06454630) evaluating REGN7508 for preventing blood clots after knee replacement surgery, the overall rate of treatment-emergent adverse events (TEAEs) was lower in participants receiving REGN7508 compared to those receiving enoxaparin, another blood clot prevention medication. 21.7% of participants taking REGN7508 experienced at least one TEAE, compared to 28.8% of participants taking enoxaparin.
Neither REGN7508 nor enoxaparin were associated with major bleeding or clinically relevant non-major (CRNM) bleeding events in this study, with 0% of participants in both groups experiencing these types of bleeding.
Some participants developed anti-drug antibodies. Approximately 3.4% of participants (4 out of 116) treated with REGN7508 developed anti-REGN7508 antibodies.
Clinical Trial Results
REGN7508 for Preventing Blood Clots After Knee Replacement
In a clinical trial (NCT06454630) investigating REGN7508 for the prevention of blood clots following knee replacement surgery in adults, REGN7508 demonstrated a lower incidence of venous thromboembolism (VTE) compared to enoxaparin. A confirmed VTE occurred in 7.1% of participants treated with REGN7508, whereas 17.2% of participants treated with enoxaparin experienced a VTE. This included deep venous thrombosis (DVT), which also occurred in 7.1% of the REGN7508 group and 17.2% of the enoxaparin group.
Furthermore, major VTE events were not observed in the REGN7508 group, with 0% of participants experiencing a major VTE. In comparison, 1.7% of participants treated with enoxaparin experienced a major VTE.
The study also measured how REGN7508 affected blood clotting factors. The activated partial thromboplastin time (aPTT) showed a greater increase from baseline in participants receiving REGN7508 compared to those receiving enoxaparin. The mean fold change from baseline for aPTT ranged from 1.01 to 3.24 for REGN7508, indicating a stronger anticoagulant effect. For enoxaparin, the mean fold change for aPTT ranged from 1.04 to 1.15. Prothrombin time (PT) changes were minimal for both treatments, with mean fold changes ranging from 0.94 to 1.11 for REGN7508 and 0.94 to 1.02 for enoxaparin.
Blood tests confirmed that REGN7508 was present in the participants' serum, with mean concentrations ranging from 0.696 to 54.3 milligrams per liter (mg/L) across different measurements.
Currently Recruiting Trials
Several clinical trials are actively seeking participants to further investigate REGN7508, an experimental drug developed by Regeneron Pharmaceuticals. These studies aim to understand its effectiveness and safety across various conditions related to blood clot prevention and treatment.
- One Phase 3 study, NCT07493304, is recruiting up to 1600 adult participants with solid and hematologic cancers who have experienced venous thromboembolism (VTE), or blood clots in veins. This trial compares REGN7508 with apixaban for both treatment and secondary prevention of VTE.
- Another large Phase 3 trial, NCT07318610, is focused on reducing adverse vascular outcomes in adults with peripheral artery disease (PAD). This study plans to enroll 7050 participants and is researching REGN7508 alongside another experimental drug, REGN9933.
- For individuals with atrial fibrillation (AF) for whom oral anticoagulation is unsuitable, a Phase 3 study (NCT07430956) is investigating REGN7508 and REGN9933 for stroke and systemic embolism prevention. This trial aims to include 2628 adult participants.
- A Phase 3 study, NCT07410117, is dedicated to the prevention of cancer-associated thrombosis (CAT) in adults with solid tumors. This trial is researching REGN7508 and plans to enroll 1120 participants.
- Two Phase 3 trials are comparing REGN7508 for venous thromboprophylaxis after total knee arthroplasty (TKA). Study NCT07213778 is comparing REGN7508 against acetylsalicylic acid (ASA) in 2000 adult participants, while study NCT07015905 is comparing REGN7508 against apixaban and enoxaparin, also targeting 2000 adults undergoing TKA.
- Finally, a Phase 2 safety study, NCT07175428, is evaluating REGN7508 and REGN9933 in adult participants with atrial fibrillation who are already receiving anticoagulation treatment. This study is designed for 1200 individuals.
Where to Participate
Clinical trials for REGN7508 are being conducted across a wide geographic area, offering many opportunities for participation. These studies are active at 72 sites in 63 cities across 21 states within the United States. Some of the locations with the most active sites include:
- Indianapolis, Indiana (4 sites)
- Amarillo, Texas (3 sites)
- Winter Park, Florida (2 sites)
- Columbus, Ohio (2 sites)
- San Antonio, Texas (2 sites)
- Pasadena, California (2 sites)
- Baltimore, Maryland (2 sites)
- Fremont, California (2 sites)
- Huntington Beach, California (2 sites)
- Marion, Ohio (2 sites)
To be eligible for these studies, participants must be adults aged 18 years or older. All genders are welcome, but these trials are not open to healthy volunteers or children, focusing specifically on individuals with the medical conditions being studied.
Development Timeline
The journey of REGN7508 began with its first clinical trial on November 2, 2022, driven entirely by Regeneron Pharmaceuticals. Initially, the research focused on conditions such as irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia, exploring the drug's potential in these areas.
As development progressed, the focus of REGN7508 expanded significantly. The pipeline grew to include a broader range of cardiovascular and thrombotic conditions. Studies began investigating its role in venous thromboembolism (VTE), peripheral artery disease (PAD), symptomatic VTE, and cancer-associated thrombosis (CAT), demonstrating a strategic shift towards addressing critical blood clot-related challenges.
To date, a total of 11 clinical trials have been initiated for REGN7508, targeting a combined enrollment of 18,276 participants. These trials have moved through various stages of development, with two studies reaching Phase 1, three progressing to Phase 2, and a significant six trials now in the advanced Phase 3 stage. The latest planned trial is set to conclude by March 25, 2026, marking continued commitment to understanding REGN7508's full potential.