Positive 6-month phase 2 results for sustained delivery of K8 in geographic atrophy

Inflammasome Therapeutics announced in a press release both positive phase 2 results achieved by kamuvudine-8 (K8), its investigational drug, for geographic atrophy (GA) and a good safety signal over the 6-month period of evaluation.¹ The company also reported significantly slower GA progression and a visual acuity (VA) advantage.¹

The 0.7-mg dose, one of three doses of K8 tested, showed a significant (P = .016) 54% reduction in GA growth 54% compared with the control group.

K8 is an investigational dual inflammasome inhibitor that is being developed as a sustained-release intravitreal implant. According to the press release, K8 inhibits convergent inflammasome pathways associated with chronic inflammation, retinal tissue damage, and neurodegeneration in GA.¹

Study design and results

The multicenter US study, the results of which were reported at the annual meeting of the American Society of Retina Specialists in Montreal, included 30 participants (60 eyes) with bilateral GA from nine clinical centers. Professor Jayakrishna Ambati, MD, Director of the Center for Advanced Vision Science and DuPont Guerry, III Professor of Ophthalmology at the University of Virginia, Charlottesville, reported the results at the conference.

The worse-seeing eye of each participant received a bioerodible K8 intravitreal implant; the fellow eye was not treated. The study evaluated three doses: 0.3, 0.7, and 1.05 mg. After the baseline injection, the participants underwent another injection at month 3. The study also included a control group. The patients were evaluated once every 3 months.

K8 was administered during an in-office procedure using a 24-gauge preloaded injector. No refrigeration or cold-chain storage is required.

The investigators reported, “The 0.7-mg cohort showed a 54% lower mean rate of GA growth (slope) than control eyes over 6 months (two-sided P = .016, FDA-preferred slope analysis); a prespecified extrafoveal analysis showed an adjusted 4.0-letter mean BCVA advantage for K8 versus the control (two-sided P = .004).”¹

They also found that the three K8 dose cohorts in this trial exhibited a slowed mean rate of GA growth compared with the pooled control group over 6 months to a substantially greater extent than these previous benchmarks.

The results did not identify any concerning safety signals over 6 months. Specifically, no drug-related serious adverse events, dose-limiting toxicities, endophthalmitis, intraocular inflammation, neovascular age-related macular degeneration, retinal vasculitis, or optic neuropathy occurred.

Ambati pointed out that that the combination of reduced lesion growth and a VA signal suggests that K8 might affect both retinal-cell survival and function.¹ "Clearing the high bar of 50% in slowing lesion growth and preserving or improving visual function suggests that K8 not only stops retinal cells from dying but also improves the function of distressed cells by reducing inflammation. The statistical significance of K8’s lesion growth reduction fulfills the promise of earlier studies that predicted that a drug with strong efficacy could demonstrate a statistically significant effect in GA with 30 patients. The dual benefit of K8 on structure and function should now be confirmed in phase 3 studies.”

Other responses to the results

Anat Loewenstein, MD, MHA,Professor of Ophthalmology and Vice President at the Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Gray Faculty of Medical and Health Sciences, Tel Aviv University, and a member of the Retina Scientific Advisory Board of Inflammasome Therapeutics, commented, “In my opinion, we have a real chance for a breakthrough. There is a huge unmet need in the management of GA, which remains the main reason for VA loss in macular degeneration. Since we have a signal here for a treatment resulting in both a lower lesion growth rate and a VA benefit, this reflects the direction the retina community has been seeking. I firmly believe these results warrant rigorous confirmation in phase 3.”

Professor Frank Holz, MD, PhD, Professor and Chairman of the Department of Ophthalmology at the University of Bonn, Germany, said, “These K8 phase 2 results are spectacular and extremely encouraging. I look forward to the phase 3 trials starting as soon as possible so that these findings may be confirmed and a more efficacious treatment for GA can be developed.”

The future

Inflammasome Therapeutics plans to initiate a global phase 3 pivotal program to evaluate K8 for treating GA and will seek regulatory input. K8 remains investigational and has not been approved by the FDA or any other regulatory authority. Its safety and efficacy have not been established.

In addition to being investigated as a treatment for ocular diseases, the K8 platform also has been selected for testing in amyotrophic lateral sclerosis, according to the press release.¹

Reference

1. Inflammasome Therapeutics reports positive six-month phase 2 results for K8 in geographic atrophy. News release. Inflammasome Therapeutics. July 17, 2026. Accessed July 17, 2026. https://inflam.com/inflammasome-therapeutics-reports-positive-six-month-phase-2-results-for-k8-in-geographic-atrophy