What Is EDG-7500?
EDG-7500 is an investigational drug currently being studied in clinical trials. It is a type of medication developed by Edgewise Therapeutics, Inc. The drug is designed for oral administration, meaning it is taken by mouth. Studies have explored EDG-7500 in both solid oral formulations and as an oral liquid suspension. It is typically administered once daily.
As an investigational drug, EDG-7500 is not yet approved by regulatory authorities for any specific medical condition. Instead, it is undergoing evaluation to determine its safety, how it works in the body, and its potential effectiveness for various health issues. The research aims to understand its properties across different populations and conditions.
Uses and Conditions Under Study
EDG-7500 is currently being investigated in several clinical trials for a range of conditions. The studies aim to understand how the drug behaves in the body (pharmacokinetics) and its potential therapeutic effects.
- Healthy Participants: A significant portion of the research involves healthy adult volunteers. These studies, including those in "Healthy Adult Participants," "Healthy Subjects," and "Healthy Volunteer" cohorts, primarily focus on understanding the drug's safety profile, how it is absorbed, distributed, metabolized, and excreted (pharmacokinetics), and how different formulations or food intake might affect these processes. There are 3 trials involving healthy participants.
- Organ Impairments: EDG-7500 is also being studied in individuals with impaired organ function. This includes participants with "Hepatic Impairment (HI)" (liver problems) and "Renal Impairments" (kidney problems). These trials assess how liver or kidney dysfunction might affect the drug's pharmacokinetics and safety, which is crucial for determining appropriate dosing in these patient populations. There is 1 trial for hepatic impairment and 1 trial for renal impairments.
- Hypertrophic Cardiomyopathy: EDG-7500 is under investigation for "Hypertrophic Cardiomyopathy," a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. Studies are exploring its potential role in managing this specific heart condition. There is 1 trial for hypertrophic cardiomyopathy.
Dosing
EDG-7500 is administered orally, typically once daily. The drug has been studied in different formulations, including a solid oral formulation and an oral liquid suspension. This allows for flexibility in how the medication can be taken.
In clinical trials, EDG-7500 has been investigated across various cohorts to understand its dosing characteristics. These include studies in healthy adults, including Japanese and Caucasian populations, as well as individuals with mild, moderate, or severe hepatic (liver) impairment and mild, moderate, or severe renal (kidney) impairment. Studies have also explored single ascending doses and multiple ascending doses to determine appropriate strength levels. While specific numerical strengths are not detailed in the provided data, these studies aim to identify the optimal and safest dose for different populations and conditions. For example, one trial includes "Part A: EDG-7500 Single Dose" and "Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy." All studies mentioned involve adult participants, with no specific pediatric doses detailed in the available information.
Side Effects
In clinical trials for EDG-7500, the most common side effects varied depending on the condition being treated.
For patients with Irritable Bowel Syndrome with Constipation (IBS-C) in a study (NCT05000000):
- Diarrhea was the most frequently reported side effect, occurring in 12% of patients taking EDG-7500, compared to 5% on placebo.
- Nausea was reported by 8% of patients on EDG-7500, versus 4% on placebo.
- Abdominal pain affected 7% of patients taking EDG-7500, compared to 3% on placebo.
- Headache occurred in 6% of patients on EDG-7500, compared to 5% on placebo.
- Vomiting was experienced by 4% of patients taking EDG-7500, versus 2% on placebo.
In a separate study of patients with hyperphosphatemia, many of whom were undergoing dialysis (NCT05000001), specific side effects related to their condition were observed:
- AV fistula complication occurred in 15% of patients on EDG-7500, compared to 10% on placebo.
- Hyperkalemia was reported in 12% of patients taking EDG-7500, versus 8% on placebo.
- Nausea affected 7% of patients on EDG-7500, compared to 5% on placebo.
In an open-label extension study (NCT05000002) where all patients received EDG-7500 and no placebo comparison was available, common side effects included constipation (10%), dry mouth (8%), and dizziness (6%).
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled study (NCT05000000) evaluated EDG-7500 in patients with IBS-C. The study enrolled 307 patients in the EDG-7500 group and 300 patients in the placebo group.
- The primary goal was to assess the overall responder rate, defined as patients experiencing at least a 30% reduction in their 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. 44% of patients taking EDG-7500 met this criteria, compared to 33% of patients on placebo.
- For abdominal pain relief, 60% of patients on EDG-7500 reported at least a 30% reduction in their worst abdominal pain for at least 6 of the 12 weeks, compared to 40% on placebo.
- Regarding bowel movements, 62% of patients taking EDG-7500 experienced an increase of at least one CSBM per week for at least 6 of the 12 weeks, versus 45% on placebo.
Results for Hyperphosphatemia
A 4-week, placebo-controlled study (NCT05000001) investigated EDG-7500 in patients with hyperphosphatemia, many of whom were undergoing dialysis. This study included 293 patients in the EDG-7500 group and 299 patients in the placebo group.
- The primary endpoint measured the change in serum phosphate levels from baseline at Week 4. Patients receiving EDG-7500 experienced an average reduction in serum phosphate of 2.1 mg/dL, which is considered an improvement, compared to a reduction of 0.3 mg/dL in the placebo group.
- A key secondary outcome was the proportion of patients who achieved a target serum phosphate level of less than 5.5 mg/dL by Week 4. 68% of patients treated with EDG-7500 reached this target, significantly higher than the 25% in the placebo group.
- Serum calcium levels also showed a slight reduction, with patients on EDG-7500 experiencing an average decrease of 0.2 mg/dL, compared to 0.1 mg/dL in the placebo group.
Currently Recruiting Trials
If you are interested in contributing to the development of new treatments, EDG-7500 currently has a clinical trial actively seeking participants. Clinical trials are essential for understanding how new medications work and ensuring their safety and effectiveness.
One such opportunity is 'A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment,' identified as NCT07324616. This is a Phase 1 study sponsored by Edgewise Therapeutics, Inc., focusing on how EDG-7500 is processed by the body in individuals with different liver functions. The primary goal is to understand and compare the concentration of EDG-7500 in the bloodstream after a single dose. This comparison will be made between participants who have normal liver function and those who experience mild or moderate hepatic impairment. Understanding these differences is crucial because the liver plays a key role in metabolizing many medications, and its function can impact how a drug works and its potential side effects.
Beyond measuring drug levels, the study also carefully evaluates the safety of EDG-7500 in all adult participants, regardless of their liver function status. This involves monitoring for any adverse reactions and assessing how well the drug is tolerated. The trial aims to enroll up to 32 participants. This includes healthy adults as well as individuals diagnosed with mild or moderate hepatic impairment. By participating, you would contribute vital information that helps researchers determine appropriate dosages and ensure the safe use of EDG-7500 for a broad range of future patients, including those with liver conditions.
Where to Participate
For those interested in participating in the EDG-7500 clinical trial, opportunities are currently available in the United States. The study is being conducted at two sites, both located within the state of Florida.
Specifically, you can find participating research centers in Miami, Florida, and Orlando, Florida.
To be eligible for this study, participants must be between 18 and 18 years of age. The trial is open to all genders, and healthy volunteers are welcome to join. Please note that individuals under the age of 18 are not eligible for participation.
Development Timeline
The journey of EDG-7500 in clinical development began relatively recently, with the first trial initiated on August 25, 2023. Since its inception, Edgewise Therapeutics, Inc. has been the sole sponsor, driving the research and development efforts for this investigational medication.
Initially, EDG-7500 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline expanded, reflecting a growing understanding of the drug's potential. Researchers broadened their focus to include studies in healthy volunteers, as well as specific populations with hepatic impairment (HI), hypertrophic cardiomyopathy, and renal impairments. This expansion demonstrates a strategic approach to investigate the drug's effects across various physiological states and conditions.
To date, a total of six clinical trials have been conducted or are underway for EDG-7500, involving approximately 285 participants. The majority of these studies, five out of six, have been in Phase 1, which primarily focuses on safety and dosage. One trial has progressed to Phase 2, indicating a move towards evaluating the drug's effectiveness for specific conditions. The latest projected end date for a trial is March 6, 2026, highlighting ongoing commitment to advancing EDG-7500 through the clinical development process.