Monday, February 10, 2020 11:49:40 AM
4:19 pm ET February 8, 2020 (Benzinga) Print
Encouraging safety profile continues with zero cases of intraocular inflammation after 420 doses in 130 patients
Strong anti-VEGF efficacy with extended dosing intervals continues to be observed across all three of the major retinal vascular diseases
Promising clinical durability continues to be observed with 84% of wet AMD treated eyes and 76% of DME treated eyes extended to four months or longer before first retreatment
55% of wet AMD eyes extended to six months and 64% of DME eyes extended to six months or longer
Kodiak Sciences Inc. (Nasdaq: KOD) today announced promising safety, efficacy and durability data from the ongoing Phase 1b study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, in patients with treatment-naïve wet age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).
The results were presented by Diana V. Do, M.D., Professor of Ophthalmology at Byers Eye Institute, Stanford University School of Medicine as an oral presentation at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami, FL. The study findings presented by Dr. Do can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.
"With further maturation of the Phase 1b study, the safety and efficacy of KSI-301 continue to be very encouraging, and we continue to see the potential for KSI-301 to have class-leading durability across all of the common retinal vascular diseases," said Jason Ehrlich, M.D., Ph.D., Chief Medical Officer of Kodiak Sciences. "Our belief is that a next-generation biologic should bring nearly all wet AMD and DME patients to a three month or longer dose interval and the majority of RVO patients to a two month or longer interval. In the data presented today at Angiogenesis, we observed that 84% of wet AMD eyes and 76% of DME eyes were extended to four months or longer after the last loading doses before receiving their first retreatment. Remarkably, 55% of wet AMD eyes and 64% of DME eyes were extended to six months. In RVO, a disease which typically requires monthly anti-VEGF therapy to achieve the best results, we continued to observe that over half the patients were extended beyond three months after only three loading doses and without receiving retreatment."
"Compared to the data previously presented, more patients have been followed for longer intervals. The safety, efficacy, and durability data continue to be robust and are suggesting the potential for KSI-301 to demonstrate a novel Generation 2.0 durability profile," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "We are very pleased with what we continue to learn about the clinical performance of KSI-301 in this exploratory study, and we are using the data to thoughtfully design high conviction pivotal studies of KSI-301 in each of the core indications. Our DAZZLE study in wet AMD, where KSI-301 is given on an every three-, four-, or five-month dosing interval, continues to recruit well. We appreciate the strong support from the ophthalmology community of patients and providers, and we look forward to initiating pivotal studies in DME, RVO, and NPDR later this year as part of our accelerating development program for KSI-301."
New York Yankees and Duke Basketball
Recent KOD News
- Kodiak Sciences Announces Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results • PR Newswire (US) • 03/28/2024 10:30:00 AM
- Kodiak Sciences to Report Fourth Quarter and Full-Year 2023 Financial Results and Host Business Updates Webcast on March 28, 2024 • PR Newswire (US) • 03/26/2024 10:15:00 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 09:23:00 PM
- Kodiak Sciences Announces Upcoming Presentation of First Time Results of KSI-501ABC Phase 1 Study at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting • PR Newswire (US) • 01/30/2024 11:30:00 AM
- Kodiak Sciences to Present at the 42nd Annual J.P. Morgan Healthcare Conference • PR Newswire (US) • 01/04/2024 09:15:00 PM
- Kodiak Sciences to Present at the 6th Annual Evercore ISI HealthCONx Conference • PR Newswire (US) • 11/21/2023 09:15:00 PM
- Kodiak Sciences Announces Third Quarter 2023 Financial Results and Recent Business Highlights • PR Newswire (US) • 11/14/2023 09:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/06/2023 11:05:54 AM
- Kodiak reboots tarcocimab tedromer development program following strong positive results in Phase 3 diabetic retinopathy GLOW study and following dialogue with US regulatory authorities on a regulatory pathway for BLA submission • PR Newswire (US) • 11/06/2023 10:00:00 AM
- KODIAK SCIENCES ANNOUNCES FIRST TIME PRESENTATION OF PRIMARY ENDPOINT DATA FROM TARCOCIMAB TEDROMER PHASE 3 GLOW STUDY IN PATIENTS WITH DIABETIC RETINOPATHY AT AMERICAN ACADEMY OF OPHTHALMOLOGY ANNUAL MEETING • PR Newswire (US) • 11/02/2023 03:21:00 AM
- Kodiak Sciences Announces Upcoming Presentations at the 56th Annual Scientific Meeting of the Retina Society • PR Newswire (US) • 10/11/2023 10:00:00 AM
- Kodiak Sciences to Present at the Morgan Stanley 21st Annual Global Healthcare Conference • PR Newswire (US) • 09/08/2023 10:00:00 AM
- New one-year results for Kodiak's tarcocimab tedromer in the pivotal BEACON trial reinforce durability signal and demonstrate matched efficacy and comparable safety and tolerability in retinal vein occlusion • PR Newswire (US) • 09/07/2023 10:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/17/2023 09:26:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2023 08:33:01 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 08:12:57 PM
- Kodiak Sciences Announces Second Quarter 2023 Financial Results and Recent Business Highlights • PR Newswire (US) • 08/14/2023 08:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/24/2023 10:45:38 AM
- Kodiak Sciences Announces Topline Results from its Phase 3 Studies of Tarcocimab Tedromer in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema and Provides Update on Tarcocimab Development Program • PR Newswire (US) • 07/24/2023 10:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/03/2023 08:24:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/03/2023 08:22:39 PM
- Kodiak Sciences to Present at Upcoming Investor Conferences • PR Newswire (US) • 05/30/2023 08:15:00 PM
- Kodiak Sciences Announces First Quarter 2023 Financial Results and Recent Business Highlights • PR Newswire (US) • 05/15/2023 08:01:00 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM