Inflammasome Therapeutics, developer of a novel category of inflammasome inhibitor medications known as Kamuvudines, announced that the FDA has given approval for the opening of a phase 1/2 clinical trial for the company's drug targeting the treatment of geographic atrophy (GA).
This marks the first clinical trial involving an inflammasome inhibitor aimed at addressing GA.
"This is a very important milestone for the company as it represents the initial clinical trial of several planned for our Kamuvudines in a number of other neuroinflammatory conditions, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), and multiple sclerosis (MS)," Paul Ashton, CEO of Inflammasome Therapeutics, said in a company news release.
Patients with GA exhibit heightened levels of toxic substances such as complement, amyloid beta, retrotransposons, iron, and reactive oxygen species in their eyes, as well as in the brains and nervous systems of patients with ALS, AD, and MS. This year witnessed the FDA approval of the first two treatments for GA, namely Syfovre and Izervay. These medications focus on different facets of one of the toxic substances, complement.
According to Dr. Ashton, a retinal specialist, although these drugs are crucial additions to the treatment options, they are not without drawbacks. They only marginally decelerate the progression of the disease and heighten the risk of developing wet AMD. Moreover, the drugs necessitate injection every 4-8 weeks. Dr. Ashton emphasized, "While it’s great that these complement inhibiting drugs are having an effect, we believe that targeting a single aspect of the disease may be suboptimal."
Dr Ashton continued: “Drug development for GA is similar to that for AD where researchers have been targeting one element of the disease. In AD, it’s amyloid beta, and in 2023 a drug was approved in this area that modestly slows the progression of this disease. We are developing Kamuvudines for AD and other central nervous system (CNS) disorders as our drugs target multiple toxic pathways – complement, amyloid beta, iron overload, retrotransposons, etc. - via their common pathway to toxicity, inflammasome activation. We believe this approach will have a more profound effect.”
Dr. Ashton said that the company is carrying out additional research on their Kamuvudines in the area of AD and intends to initiate clinical trials in this indication soon.
In the GA trial, participants will be administered a small sustained release implant designed to release the drug directly into the posterior segment of the eye for an initial three-month period following injection. The drug has been meticulously formulated for retinal delivery, and both the implants and injector system have been tailored for the precise administration of this specific drug. This integrated drug and delivery approach enables the retention of elevated therapeutic doses within the eye while ensuring the drug remains undetectable in the systemic circulation.