When biopharmaceutical company Invex Therapeutics (“Invex”) first decided to launch a clinical trial to evaluate Presendin (sustained-release exenatide) for idiopathic intracranial hypertension (IIH), the company felt excited. Presendin is a subcutaneously injected GLP-1 receptor agonist.
The company believed that Presendin could reduce intracranial pressure and improve both outcomes and quality-of-life for patients. However, reports The Market Herald, Invex has faced a roadblock in launching the Phase 3 EVOLVE study. The issue: not enough participants have enrolled.
Initially, Invex expected an enrollment of 240 people with idiopathic intracranial hypertension at 40 different global sites. Trial enrollment began in April 2022 and was expected to last for up to 24 months (2 years). Over one year later, in June 2023, enrollment has been significantly underperforming. Only 13 participants have enrolled in the study. Of the 40 expected trial sites, only 12 were launched.
Why is this? Well, there are a number of reasons including regulatory issues, drug failure rates, and smaller patient populations. Although these have interrupted the trial process currently, Invex is still planning on moving forward—with some changes. First, the company reduced the anticipated enrollment to 130 participants. Next, the company is planning on amending the study protocol and adjusting secondary endpoints.
Learn more about the EVOLVE study.
About Idiopathic Intracranial Hypertension (IIH)
You can learn more about idiopathic intracranial hypertension simply by breaking down its name:
- Idiopathic: of an unknown cause
- Intracranial: within the skull
- Hypertension: high blood pressure
So, IIH is a condition in which someone has increased pressure within the skull. Pressure within the cerebrospinal fluid is too high. This can cause a number of issues such as severe headaches and vision loss. Primary IIH typically affects females of childbearing age; it is also more common in women who are obese. However, primary IIH can also affect males and females of all ages. Secondary IIH typically has a cause, such as sleep apnea, certain medical conditions, or the use of certain medications.
Symptoms relating to idiopathic intracranial hypertension may include:
- A painful headache at the base of the neck that may worsen at night or interrupt sleep
- Nausea and vomiting
- An enlarged blind spot in your vision
- Exercise intolerance
- Double vision
- Dizziness
- Arm and back pain
- Tinnitus (ringing in the ears)
- Anxiety or depression
- Forgetfulness or problems with memory
- Neck stiffness
- Difficulty walking
