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Kodiak Sciences Inc., a pre-commercial retina-focused biotechnology company, announced that it has completed enrollment of the first 300-patient cohort in its PEAK trial, supporting Pivotal Analysis 1 of the KSI-101 phase 3 programme in macular edema secondary to inflammation (MESI). Kodiak also reaffirmed its plan to release the topline data from Pivotal Analysis 1 in December 2026.
"We were pleased to complete this important enrollment milestone in early June, and we can now confidently plan for the topline data to be released in December 2026," said Victor Perlroth, M.D., chief executive officer of Kodiak. "Our data from the phase 1b APEX study meaningfully increased our conviction in KSI-101's potential to be a cornerstone therapy for MESI patients. The global registrational PEAK trial is the first pivotal test of that conviction, and we look forward to sharing topline data before the end of this year."
"Pivotal Analysis 1 gives us the opportunity to evaluate KSI-101 in patients with more severe MESI across our global site footprint," said J. Pablo Velazquez-Martin, M.D., chief medical officer of Kodiak. "These are patients at high risk of losing meaningful vision, and the goal of treatment is not only to reduce inflammation but to dry the retina and improve vision without the toxicities and other limitations associated with today's complex patchwork of systemic and ocular therapies. KSI-101 was designed for this clinical challenge, and we are grateful to the patients, investigators and study teams who have helped bring the programme to this important milestone."
"MESI encompasses a broad range of diseases resulting in a swollen macula and which are not attributable to other common causes of retinal edema such as wet AMD, diabetic macular edema and retinal vein occlusion. MESI represents a meaningful number of patients in my retina practice," said David Eichenbaum, M.D., director of research at Retina Vitreous Associates of Florida and a principal investigator in the PEAK and PINNACLE clinical trials. "Many of these patients have experience with corticosteroid use and understand its limitations, including the risks of elevated intraocular pressure and cataract. I am encouraged by the data generated to date with KSI-101 in which the therapy appears to work well and to date is demonstrating a favourable safety profile. KSI-101 could open up treatment for MESI to many more patients and may meaningfully change the treatment paradigm for this diagnosis in retina practice in the years ahead. I'm thrilled to be on the leading edge of this program."
Macular edema secondary to inflammation (MESI) is a heterogeneous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology of inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization).
Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. Existing therapies remain limited by side effects and tolerability, underscoring the need for safer and more effective treatment options. MESI represents a new macular edema market segment separate from the established anti-VEGF market.
KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF for the treatment of MESI. Data from our dose-finding phase 1b APEX study demonstrated robust anatomical and visual responses across MESI patients. More than half of patients achieved =15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels. Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups. Continued anatomical improvement was observed over time with >90% resolution of intraretinal ("IRF") and subretinal fluid ("SRF") by Week 8 and 20/25 Snellen visual acuity by Week 20. In top dose groups, =90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture. KSI-101 also continued to be well tolerated with a favourable safety profile. The top two dose levels in APEX have been advanced into the Phase 3 pivotal studies, PEAK and PINNACLE. The PEAK and PINNACLE studies are actively enrolling.
The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients.
Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Topline data readouts for Pivotal Analysis 1 (PEAK patients 1 – 300) and Pivotal Analysis 2 (PEAK patients 301 – 600 and PINNACLE patients 1 – 300) are expected in December 2026 and 2Q 2027, respectively.
Kodiak Sciences is a pre-commercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. The company focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally.
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