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Inflammasome Therapeutics announces first patient dosed in Phase 1 trial evaluating Kamuvudine-8 treatment in patients with GA

News
Article

The non-randomized, open label, safety and efficacy study will inject a sustained release implant in 5 participants.

Physician holding injector with gloved hands Image Credit: AdobeStock/romas_ph

Image Credit: AdobeStock/romas_ph

Inflammasome Therapeutics announced its first patient has been dosed in the company’s first-in-class clinical trial for dry age-related macular degeneration (AMD).1 The non-randomized, open label, safety and efficacy study will evaluate Kamuvudine-8 (K8) for the treatment of patients with geographic atrophy (GA).2

“This marks the second trial underway with our Kamuvudines in ophthalmology,” said Paul Ashton, PhD, president and CEO of Inflammasome Therapeutics, in the release.

Inflammasome has been developing a new class of inflammasome inhibitor drugs known as Kamuvudines to be used as therapies for prevalent, degenerative diseases. In pre-clinical research, Kamuvudines have been shown to inhibit the underlying cause of vision loss in GA, according to the release. The Phase 1 trial is sponsored by the University of Kentucky and is expected to enroll 5 patients with GA due to AMD over the course of 26 weeks.1 Over the course of the trial, exams will be conducted to look for continuous changes in visual acuity, change in area of GA lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.2

Trial participants will receive a tiny, sustained release implant via intravitreal injection that will provide slow, consistent release of K8 directly into the back of the eye. The implant is expected to last for 3 months. Inflammasome’s K8 has been designed specifically for this form of retinal delivery, according to the release.1

Ashton said in the release that what makes this treatment different is its targeting of inflammasome activation, the underlying cause of GA. “Our Kamuvudines have been shown in pre-clinical studies to block inflammasome activation caused by multiple toxic pathways – complement, amyloid beta, iron overload, retrotransposons, etc. If we can block inflammasome activation in the clinic, we believe we can have a profound effect on the disease by blocking multiple pathways,” he said.

Ashton also stated that the implications for treatments in other neuroinflammatory diseases like Alzheimer disease, ALS and multiple sclerosis are “extremely interesting. We have Kamuvudines specifically designed for neurological diseases that penetrate into the brain and Central Nervous System from a simple oral tablet. Inflammasome Therapeutics is expected to begin clinical trials in some of these diseases soon as well.”

References:
  1. Inflammasome Therapeutics announces first patient dosed in geographic atrophy (GA) clinical trial. News release. Business Wire. April 29, 2024. Accessed April 30, 2024. https://www.businesswire.com/news/home/20240429438564/en/Inflammasome-Therapeutics-Announces-First-Patient-Dosed-in-Geographic-Atrophy-GA-Clinical-Trial?utm_campaign=shareaholic&utm_medium=email_this&utm_source=email
  2. ClinicalTrials.gov. Evaluation of Kamuvudine-8 in subjects with geographic atrophy (K8 for GA). NCT06164587. Updated April 23, 2024. Accessed April 30, 2024. https://clinicaltrials.gov/study/NCT06164587?id=NCT06164587&rank=1
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