Inflammasome Therapeutics Announces First Patient Dosed in Geographic Atrophy (GA) Clinical Trial
April 29 2024 - 9:15AM
Business Wire
- Phase 1 investigator-sponsored clinical trial “Evaluation of
Kamuvudine-8 in Subjects with Geographic Atrophy (K8 for GA)” for a
blinding condition resulting from dry age-related macular
degeneration (dry AMD).
- Open label 26-week study designed to evaluate the safety and
treatment efficacy of K8, a novel neuroprotectant that will target
the underlying cause of vision loss in GA.
- Expected to treat up to five subjects with intravitreous
injection of intraocular implant designed to last for three
months.
- Marks second clinical trial underway for Inflammasome
Therapeutics that uses the company’s proprietary new class of
drugs. Trial for DME also recruiting (ClinicalTrials.gov ID
NCT05699759).
- Kamuvudines are shown in pre-clinical research to inhibit the
underlying cause of vision loss in GA.
Inflammasome Therapeutics (https://www.inflam.com), a private
company developing a new class of inflammasome inhibitor drugs,
Kamuvudines, as therapies for prevalent, degenerative diseases,
announced the first patient has been dosed in a first-in-class
clinical trial for dry AMD. The Phase 1 trial (ClinicalTrials.gov
ID NCT06164587) is sponsored by the University of Kentucky and
expected to enroll up to five patients with GA due to age-related
macular degeneration (AMD).
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Inflammasome's K8, a tiny sustained
release implant that provides slow, consistent release of the drug
K8 (inflammasome inhibitor drug Kamuvudine) directly in the back of
the eye for a period of three months. (Photo: Business Wire)
Trial participants will receive a tiny, sustained release
implant (illustration is available) that will provide slow,
consistent release of the drug K8 directly into the back of the
eye. K8 was specifically designed for retinal delivery and the
implants and injector system were crafted to deliver this
particular drug. This combined drug and delivery strategy allows
high therapeutic doses to be maintained in the eye while the drug
is undetectable in systemic circulation.
“This marks the second trial underway with our Kamuvudines in
ophthalmology,” said Dr. Paul Ashton, President and CEO of
Inflammasome Therapeutics, developers of both the compounds and
delivery systems for administration.
GA affects approximately one million individuals in the US and
more than eight million worldwide. In GA, multiple toxic substances
(such as complement, amyloid beta, retrotransposons, iron, and
reactive oxygen species) build up in the eye and trigger
inflammasome activation that then causes cells in the macula to
slowly die (atrophy). This is a very similar process to what goes
on in the brain and nervous system in patients with ALS,
Alzheimer’s disease and multiple sclerosis.
Last year, two drugs (Syfovre and Izervay) were approved for GA
that target one of these toxic substances, complement. The drugs do
not target other toxic elements and only modestly slow progression
of the disease. Unfortunately, they also increase the risk of
developing wet AMD. Furthermore, the drugs require an intraocular
injection every four to eight weeks.
There is tremendous interest in developing potential GA
treatments. There are 38 other interventional clinical trials for
GA registered in clinicaltrials.gov., almost all of which target
individual toxic substances, but not the underlying cause of the
atrophy, inflammasome activation.
“That’s where we believe we provide a distinctive and
significant difference,” said Dr. Ashton. “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.”
Dr. Ashton confirmed that the implications for treatments in
other neuroinflammatory diseases like Alzheimer’s 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,” he affirmed.
Inflammasome Therapeutics’ co-founder, Dr. Jayakrishna Ambati,
has spent more than a decade developing Kamuvudines and identifying
their role in the inhibition of inflammasome activity that is being
found to be the underlying cause of many diseases. In a series of
publications in journals such as Science and Nature, he has
described the basic research on GA and pre-clinical development of
Kamuvudines:
https://www.science.org/doi/10.1126/science.1261754
https://www.nature.com/articles/nature09830
https://www.science.org/doi/10.1126/sciadv.abj3658
https://www.science.org/doi/10.1126/sciimmunol.abi4493
Dr. Ambati and Dr. Ashton co-founded Inflammasome Therapeutics
in 2016 to develop therapies for prevalent, degenerative diseases
and to develop novel delivery technologies for the sustained
release of therapeutic agents and compounds. The company combines
scientific excellence with proven development expertise and works
to develop products via a mixture of licensing agreements and
internal development, including work with Boehringer Ingelheim and
the Gates Foundation.
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Beverly Jedynak, Bevlyn Consulting, blj@bevlynconsulting.com,
312-943-1123; 773-350-5793 (cell)