 |
Products |  |
Diseases | | Products |
|
Trials |  |
News |  |
| 12» |
- || Review, Journal: Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues. (Pubmed Central) - Jan 14, 2025
Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and
- || PK/PD data, Review, Journal: Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability. (Pubmed Central) - Sep 11, 2024
Recent phase 3 trials demonstrated modest improvements in durability, but failures that might be attributed to these strategies (conjugation and manufacturing processes) have occurred. Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy.
- |||||||||| tabirafusp tedromer (KSI-501) / Kodiak Sciences, tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (clinicaltrials.gov) - Aug 15, 2024
P3, N=675, Recruiting, Sponsor: Kodiak Sciences Inc
- tarcocimab tedromer (KSI 301) / Kodiak Sciences
Phase classification: DAZZLE: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (clinicaltrials.gov) - Jul 17, 2024
P2/3, N=559, Terminated, Sponsor: Kodiak Sciences Inc
Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy. Phase classification: P2b --> P2/3
- || Review, Journal: Perspectives on the currently available pharmacotherapy for wet macular degeneration. (Pubmed Central) - Jun 7, 2024
While current treatments for w-AMD have significantly advanced with the advent of anti-VEGF therapies, their limitations in terms of treatment burden and incomplete responses have spurred research into diverse alternative approaches. These innovative strategies offer hope for improving patient outcomes and reducing healthcare burdens, suggesting a promising future for w-AMD management.
- |||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment open: GLOW2: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR) (clinicaltrials.gov) - Apr 7, 2024
P3, N=250, Recruiting, Sponsor: Kodiak Sciences Inc
These innovative strategies offer hope for improving patient outcomes and reducing healthcare burdens, suggesting a promising future for w-AMD management. Not yet recruiting --> Recruiting
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: GLOW2: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR) (clinicaltrials.gov) - Feb 21, 2024
P3, N=250, Not yet recruiting, Sponsor: Kodiak Sciences Inc
- ||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial termination, Trial primary completion date: GLOW: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR) (clinicaltrials.gov) - Nov 13, 2023
P3, N=253, Terminated, Sponsor: Kodiak Sciences Inc
Trial completion date: Nov 2024 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Aug 2023; All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor.
- ||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial termination: GLEAM: A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Oct 2, 2023
P3, N=460, Terminated, Sponsor: Kodiak Sciences Inc
Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor. Trial completion date: Mar 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet primary endpoint
- ||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial termination: GLIMMER: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Oct 2, 2023
P3, N=459, Terminated, Sponsor: Kodiak Sciences Inc
Trial completion date: Mar 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet primary endpoint Trial completion date: Feb 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet primary endpoint
- tarcocimab tedromer (KSI 301) / Kodiak Sciences
Outcomes From the Randomized, Controlled Phase 3 GLOW Trial: Management of Diabetic Retinopathy with KSI-301 (WEST 3004) - Aug 21, 2023 - Abstract #AAO2023AAO_358;
- ||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion: DAYLIGHT: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - May 30, 2023
P3, N=557, Completed, Sponsor: Kodiak Sciences Inc
Trial completion date: Feb 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet primary endpoint Active, not recruiting --> Completed
- ||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion, Trial completion date: BEACON: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - Feb 9, 2023
P3, N=568, Completed, Sponsor: Kodiak Sciences Inc
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> Jan 2023
- || pegcetacoplan intravitreal (APL-2 intravitreal) / Apellis
Review, Journal: Factors That Can Prolong Ocular Treatment Duration in Age-Related Macular Degeneration. (Pubmed Central) - Jan 11, 2023
More effective and longer-lasting treatments are needed for wAMD to prolong drug action and reduce dosing frequency. Several strategies are under investigation and the prevention of vision loss in patients with AMD or other retinal diseases may be attainable in the near future.
- | Journal: Efficacy and safety of intravitreal anti-VEGF therapy in diabetic retinopathy: what we have learned and what should we learn further? (Pubmed Central) - Oct 22, 2022
Recent clinical research for future anti-VEGF molecules aims to provide higher target-protein binding affinity and prolonged therapeutic effect. Brolucizumab, faricimab, and KSI-301 are three novel anti-VEGF agents that demonstrate promising data for the management of DME and potentially DR.
- | pegcetacoplan intravitreal (APL-2 intravitreal) / Apellis
Journal: Investigational drugs in clinical trials for macular degeneration. (Pubmed Central) - Oct 19, 2022
The most promising future therapies for eAMD, are those that target, more potently inhibit and have a more sustained effect on the VEGF pathway such as KSI-301, RGX-314, CLS-AX, EYEP-1901, OTX-TKI...Inhibiting phagocytic activity of retinal microglial/macrophages at the border of GA and reducing complement derived activators of microglial/macrophage is the most promising strategy. Complement inhibitors (Pegcetacoplan and Avacincaptad pegol) will likely obtain FDA approval but will serve to pave the way for combined complement and direct phagocytic inhibitors such as AVD-104.
- ||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed: GLOW: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR) (clinicaltrials.gov) - Sep 26, 2022
P3, N=253, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Complement inhibitors (Pegcetacoplan and Avacincaptad pegol) will likely obtain FDA approval but will serve to pave the way for combined complement and direct phagocytic inhibitors such as AVD-104. Recruiting --> Active, not recruiting
- tarcocimab tedromer (KSI 301) / Kodiak Sciences
KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion: Primary and Secondary 24-Week Efficacy and Safety Outcomes of the BEACON Phase III Pivotal Study (ARIE CROWN) - Jul 2, 2022 - Abstract #AAO2022AAO_585;
- |||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial termination: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO (clinicaltrials.gov) - Jun 21, 2022
P1, N=121, Terminated, Sponsor: Kodiak Sciences Inc
Recruiting --> Active, not recruiting Trial completion date: Jan 2023 --> Jun 2022 | Active, not recruiting --> Terminated; All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.
- |||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial termination: DAZZLE: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (clinicaltrials.gov) - Jun 6, 2022
P2b, N=558, Terminated, Sponsor: Kodiak Sciences Inc
Trial completion date: Jan 2023 --> Jun 2022 | Active, not recruiting --> Terminated; All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities. Trial completion date: Nov 2022 --> Apr 2022 | Active, not recruiting --> Terminated; Primary Endpoint Not Met
- ||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed, Trial completion date, Trial primary completion date: GLEAM: A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Jun 6, 2022
P3, N=460, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Trial completion date: Nov 2022 --> Apr 2022 | Active, not recruiting --> Terminated; Primary Endpoint Not Met Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Oct 2022 --> May 2023
- ||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed, Trial completion date, Trial primary completion date: GLIMMER: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Jun 6, 2022
P3, N=459, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Oct 2022 --> May 2023 Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Feb 2024 | Trial primary completion date: Oct 2022 --> Apr 2023
- ||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed, Trial completion date, Trial primary completion date: BEACON: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - Jun 6, 2022
P3, N=568, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Feb 2024 | Trial primary completion date: Oct 2022 --> Apr 2023 Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jul 2023 | Trial primary completion date: Apr 2022 --> Jul 2022
- ||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed: DAYLIGHT: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - Jun 5, 2022
P3, N=557, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jul 2023 | Trial primary completion date: Apr 2022 --> Jul 2022 Recruiting --> Active, not recruiting
- iridescimab vidros (KSI 301) / Kodiak Sciences
Efficacy, durability and safety of KSI-301 antibody biopolymer conjugate in wet AMD – primary Year 1 results of the pivotal DAZZLE study (Main Room) - May 25, 2022 - Abstract #Macula2022Macula_29;
P2b
Treatment outcomes with currently available anti-VEGF therapies are dependent on a treatment frequency that is challenging to sustain or inaccessible in real-world clinical settings. The DAZZLE study’s efficacy, durability and safety results will provide important confirmatory evidence on the potential role of KSI-301 as a more-durable anti-VEGF treatment option for patients with wet AMD.
- | iridescimab vidros (KSI 301) / Kodiak Sciences
Journal: KSI-301: an investigational anti-VEGF biopolymer conjugate for retinal diseases. (Pubmed Central) - May 7, 2022
Despite varied results in the phase 2b/3 study for nAMD, there is potential for KSI-301 to serve as a durable therapy for VEGF-mediated retinal disorders. Ongoing phase 3 trials for nAMD, DME and RVO will provide additional evidence on its efficacy, duration and safety profiles.
- iridescimab vidros (KSI 301) / Kodiak Sciences
Efficacy, durability and safety of KSI-301 antibody biopolymer conjugate in wet AMD – Year 1 primary endpoint results from the pivotal DAZZLE study (205/207) - Apr 29, 2022 - Abstract #ARVO2022ARVO_1704;
P2b
The DAZZLE study’s efficacy, durability and safety results will provide important confirmatory evidence on the potential role for KSI-301 as a more durable anti-VEGF treatment option for patients with wet AMD. Images: Figure 1.
- || Clinical, Review, Journal: Next-generation anti-VEGF agents for diabetic macular oedema. (Pubmed Central) - Apr 19, 2022
In this manuscript, we cover pharmacodynamics, preliminary results from clinical trials, and safety behavior about brolucizumab, faricimab, conbercept, KSI-301, and port-delivery system WR42221. These treatments might present the first step to control the global epidemic of diabetic eye disease in real life.
- || Review, Journal: Vascular Endothelial Growth Factor Antagonists: Promising Players in the Treatment of Neovascular Age-Related Macular Degeneration. (Pubmed Central) - Dec 16, 2021
Sustained-release anti-VEGF therapies include the ranibizumab Port Delivery System (in phase 3 studies), GB-102 (Phase 2b), OTX-TKI (phase 1), and Durasert (preclinical)...Genetic therapies in phase 1 studies include RGX-314 and ADVM-022, which introduce a viral vector that modifies the retina's cellular apparatus to create an anti-VEGF biofactory, potentially serving as a one-time treatment. Further investigation is warranted for drugs and delivery systems that hope to advance visual outcomes and reduce treatment burden of nAMD.
- || Avastin (bevacizumab) / Roche
Review, Journal: Current and Future Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration. (Pubmed Central) - Oct 8, 2021
Newer and future anti-VEGF therapies aim to decrease injection frequency through eitherlonger half life or port-delivery systems (brolucizumab, conbercept, KSI-301, ranibizumab). This review outlines current anti-VEGF treatments and ways by which their duration might be extended.
- || Eylea (aflibercept intravitreal) / Bayer, Regeneron
Review, Journal: Pipeline therapies for neovascular age related macular degeneration. (Pubmed Central) - Oct 3, 2021
Those in the pipeline of VEGF targets include abicipar pegol (Abicipar; Allergan, Coolock, Dublin), OPT-302 (Opthea; OPTHEA limited; Victoria, Melbourne), conbercept (Lumitin; Chengdu Kanghong Pharmaceutical Group, Chengdu, Sichuan), and KSI-301 (Kodiak Sciences, Palo Alto, CA)...Gene therapy present possible longer treatments options as well and are reviewed here. This paper will highlight the past approved medications as well as pipeline therapies for neovascular AMD.
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: GLOW: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR) (clinicaltrials.gov) - Oct 3, 2021
P3, N=240, Recruiting, Sponsor: Kodiak Sciences Inc
- || tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date, Trial primary completion date: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO (clinicaltrials.gov) - Sep 2, 2021
P1, N=121, Active, not recruiting, Sponsor: Kodiak Sciences Inc
This paper will highlight the past approved medications as well as pipeline therapies for neovascular AMD. Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jun 2021 --> Jan 2023
- ||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Trial completion date: BEACON: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - Aug 22, 2021
P3, N=550, Recruiting, Sponsor: Kodiak Sciences Inc
Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jun 2021 --> Jan 2023 Trial completion date: Nov 2022 --> Mar 2023
- || KSI 301 / Kodiak Sciences
Review, Journal: KSI-301: antibody biopolymer conjugate in retinal disorders. (Pubmed Central) - Jul 23, 2021
This review article showcases the biophysical properties and ongoing trials related to KSI-301. Moreover, we discuss the efficacy and safety profile of KSI-301 on the basis of the results of available trials.
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: DAYLIGHT: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - Jul 14, 2021
P3, N=500, Recruiting, Sponsor: Kodiak Sciences Inc
- KSI 301 / Kodiak Sciences
[VIRTUAL] Biophysical Characterization of Antibody Biopolymer Conjugate (ABC) Platform for Improved Therapy of Retinal Vascular Diseases () - May 13, 2021 - Abstract #ARVO2021ARVO_1881;
These underlying biophysical properties may also contribute to the observed enhanced tissue penetration and improved treatment durability seen for ABC-based therapeutics such as KSI-301. In addition to KSI-301, various ABC platform based biologic or biologic + small molecule therapeutics are in earlier stages of development.
- | Journal: Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020. (Pubmed Central) - Apr 10, 2021
Nine other upcoming agents have at least produced results in the 2A phase including intravitreal injections (KSI-301, OPT-302, RGX-314, ICON-1, and DE-122), depot (GB-102), drug reservoir (PDS), topical drops (PAN-90806), and oral formulations (AKST4290). We summarize all the newer molecules.
- ||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed: DAZZLE: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (clinicaltrials.gov) - Nov 19, 2020
P2b, N=550, Active, not recruiting, Sponsor: Kodiak Sciences Inc
We summarize all the newer molecules. Recruiting --> Active, not recruiting
- KSI 301 / Kodiak Sciences
[VIRTUAL] One Year and Beyond: Long-Term Multiple-Dose Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate with Extended Durability, in wAMD, DME, and RVO () - Nov 11, 2020 - Abstract #AAO2020AAO_884;
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: GLEAM: A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Nov 1, 2020
P3, N=450, Recruiting, Sponsor: Kodiak Sciences Inc
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: GLIMMER: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (clinicaltrials.gov) - Oct 26, 2020
P3, N=450, Recruiting, Sponsor: Kodiak Sciences Inc
- |||||||||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
New P3 trial: BEACON: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - Oct 18, 2020
P3, N=550, Recruiting, Sponsor: Kodiak Sciences Inc
- KSI 301 / Kodiak Sciences
[VIRTUAL] Results of an ongoing phase 1b study of KSI-301, an Anti-VEGF antibody biopolymer conjugate with extended durability with promising preliminary results in wAMD, DME, and RVO (Abstract Channel) - Sep 28, 2020 - Abstract #EURETINA2020EURETINA_1310;
P1
Preliminary results of a Phase 1b proof of concept study, demonstrate strong efficacy with a remarkable biological durability. KSI-301 continues to have an excellent safety profile with no intraocular inflammation or other unexpected safety events.
- KSI 301 / Kodiak Sciences
[VIRTUAL] Updated Results of Phase 1b Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate w Durability, in wAMD, DME, and RVO () - Sep 15, 2020 - Abstract #RSLONDON2020RS_LONDON_6;
P1
KSI-301 has an excellent safety profile and biological durability. Recruitment of a pivotal study (DAZZLE) in wAMD comparing KSI-301 every 3-5 months vs aflibercept is underway.
- ||| tarcocimab tedromer (KSI 301) / Kodiak Sciences
Phase classification, Enrollment change: DAZZLE: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (clinicaltrials.gov) - Sep 2, 2020
P2b, N=550, Recruiting, Sponsor: Kodiak Sciences Inc
Recruitment of a pivotal study (DAZZLE) in wAMD comparing KSI-301 every 3-5 months vs aflibercept is underway. Phase classification: P2 --> P2b | N=368 --> 550
- || tarcocimab tedromer (KSI 301) / Kodiak Sciences
Enrollment closed, Trial completion date, Trial primary completion date: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO (clinicaltrials.gov) - Jul 1, 2020
P1, N=121, Active, not recruiting, Sponsor: Kodiak Sciences Inc
Phase classification: P2 --> P2b | N=368 --> 550 Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jan 2022 | Trial primary completion date: Jun 2020 --> Jun 2021
- KSI 301 / Kodiak Sciences
Updated Results of Phase 1b Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate with Extended Durability, in wAMD, DME, and RVO (Room 301) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5037;
P1
In DME 72% of DME eyes have been extended to four months or longer, and half of RVO eyes have been extended to 3 months or longer. The results demonstrate strong functional and anatomic outcomes with excellent safety and durability profile for KSI-301 molecule.
- KSI 301 / Kodiak Sciences
Characterization of Antibody Biopolymer Conjugate reveals superior biophysical properties compared to naked antibodies (Exhibit Hall: Posterboard# A0323) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4917;
Here, we present the biophysical characterization of KSI-301, a novel anti-VEGF ABC, which is currently in clinical testing for the treatment of retinal vascular diseases.Methods Intermolecular interactions of KSI-301 Conjugate or KSI-301 Protein (IgG only) were assessed by A2 (SEC-MALS) and KD (DLS) measurements at various pH and salt concentrations...These underlying biophysical properties may also contribute to the observed enhanced tissue penetration and improved ocular distribution seen for ABC. Altogether, our continuing studies demonstrate the ABC system is an important new platform with the potential to treat a wide array of retinal diseases.
- KSI 301 / Kodiak Sciences
OCT Outcomes in Eyes Treated with KSI-301 (BLUE Hall) - Dec 5, 2019 - Abstract #OCTA2019OCTA_186;