It has come to light that patient with idiopathic intracranial hypertension- IIH can be treated with an injectable peptide used for type 2 diabetes. This has been found in a Phase II trial. As per the study’s latest findings, the brain pressure was reduced significantly in just about two and a half hours after an exenatide injection, which is a GLP-1 receptor agonist.
IIH happens to be a condition that goes on to raise the pressure in the brain, which is most likely due to a cerebrospinal fluid imbalance. One of the major risk factors for developing IIH is weight gain. The symptoms include chronic headaches, which can also lead to pressure on the optic nerve, resulting in blindness. This illness predominantly has an impact on women aged 25 to 36. Although this condition is rare, the scientists have highlighted that there has been a surge of 350% in these incidences over the last 10 years.
Apparently, there aren’t any licensed drugs as of now to treat IIH, and therefore, this result happens to be a major step forward for patients suffering from it, said Alex Sinclair, who happens to be the professor of neurology at the University of Birmingham’s Institute of Metabolism and Systems Research. He is the lead investigator of this study.
Across the 16 patients in the clinical trial, the subcutaneous injection, which was administered twice daily, went on to facilitate an average of 7.7 fewer days in a month when it came to headaches as compared to the baseline. This was in comparison to just 1.5 fewer days when it came to the placebo arm.
Of the seven patients who received the regular exenatide injection, a drop in the brain pressure was observed in both the short-term (i.e., 2.5 hours and 24 hours) and the long-term (a 12-week measurement).
While all the female participants of the trial were able to continue exenatide with some mild adverse effects, the treatment did cause nausea because of the twice-daily delivery of the drug through injection. Because of this, the drug has now been reformulated as Presendin. This once-a-week injection is designed to lower brain pressure within hours of administering it, with the dose lasting for a week.
The chair of the patient charity at IIH UK, Shelly Williamson, stated that they look forward to the next steps and see the drug being tested in two massive Phase III clinical trials. The IIH Advance is a Phase III clinical trial in adolescents that is run across the UK and sponsored by the University of Birmingham. The trial will go on to randomize patients with IIH so as to determine the safety as well as efficacy of Presendin against the placebo.
On the other hand, IIH EVOLVE happens to be an international Phase III clinical trial that will randomize 240 adult patients with newly diagnosed IIH and papilloedema so as to gauge the efficacy as well as safety when it comes to Presendin, which is administered once a week for 24 weeks. Apparently, the primary endpoint of IIH EVOLVE will analyse the efficacy of Presendin so as to reduce intracranial pressure for 24 weeks as compared to the placebo.
Keywords- Idiopathic Intracranial Hypertension, International Phase III Clinical Trial, GLP-1 Receptor Agonist, Randomize Patients With IIH, Drug Has Now Been Reformulated As Presendin.