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Kodiak (KOD) Completes Enrolling Patients in Retina-Based Studies
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Kodiak Sciences (KOD - Free Report) announced that it has completed the enrolment of more than 900 patients with diabetic macular edema ("DME") in two phase III studies — GLEAM and GLIMMER — evaluating its anti-VEGF candidate, KSI-301
The GLEAM and GLIMMER studies are designed to evaluate the durability, efficacy and safety of KSI-301 in treatment-naïve patients with DME.
Both the GLEAM and GLIMMER studies will randomize participants to receive either intravitreal KSI-301 or Eylea (aflibercept). Patients who are selected to receive KSI-301 will be dosed every 8 to 24 weeks following three loading doses, while patients receiving Eylea will be dosed every 8 weeks after five loading doses. Although the patients in both studies will be treated and followed for two years, the primary endpoint for the two studies is at one year.
Shares of Kodiak Sciences were up 3% following the announcement. Yet, the stock has plunged 58.7% in the trailing 12 months in comparison with the industry’s 40.1% decline.
Image Source: Zacks Investment Research
Apart from DME, Kodiak is also evaluating the KSI-301 for treating various retinal vascular diseases.
Kodiak is conducting a pivotal phase IIb/III DAZZLE study evaluating KSI-301 in patients with treatment-naïve wet-age-related macular degeneration (wet AMD). A phase III BEACON study is also evaluating KSI-301 to address macular edema due to retinal vein occlusion (RVO).
Similar to the GLEAM and GLIMMER studies, both the DAZZLE and BEACON studies have also completed enrolment. Kodiak expects to report top-line data from the DAZZLE and BEACON studies in first-quarter 2022 and mid-2022, respectively.
Kodiak is also evaluating KSI-301 in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME.
The company is also enrolling participants in a phase III DAYLIGHT study, which will evaluate the safety and efficacy of high-frequency KSI-301 in patients with treatment-naïve wet AMD.
Kodiak remains on course to file a single biologics license application for KSI-301 to treat wet AMD, DME and RVO. Data from all these studies are expected to be included in the initial BLA for KSI-301.
Given lucrative market opportunities, a potential approval for KSI-301 could be a major breakthrough for KOD, which currently lacks a marketed drug in its portfolio. Currently, KSI-301 is the company’s only candidate in Kodiak’s pipeline under clinical development. KOD is currently evaluating other candidates in preclinical studies.
Like KSI-301, Eylea is also an anti-VEGF treatment that has been developed by Regeneron (REGN - Free Report) in collaboration with Bayer‘s (BAYRY - Free Report) HealthCare unit.
Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications including DME, wet AMD and RVO. While Regeneron records net product sales of Eylea in the United States, Bayer records net product sales of Eylea outside the country.
Eylea’s blockbuster sales have put a spotlight on the use of VEGF inhibitor medications for the treatment of retinal indications.
Last September, REGENXBIO (RGNX - Free Report) entered into a collaboration deal with pharma giant AbbVie to co-develop and co-commercialize RGX-314, an investigational one-time gene therapy for the treatment of wet AMD and other chronic retinal diseases.
Per the agreement terms, REGENXBIO will receive $370 million as an upfront payment from AbbVie. REGENXBIO will further be eligible to receive potential milestone payments up to $1.38 billion. The deal was closed in November 2021.
Image: Bigstock
Kodiak (KOD) Completes Enrolling Patients in Retina-Based Studies
Kodiak Sciences (KOD - Free Report) announced that it has completed the enrolment of more than 900 patients with diabetic macular edema ("DME") in two phase III studies — GLEAM and GLIMMER — evaluating its anti-VEGF candidate, KSI-301
The GLEAM and GLIMMER studies are designed to evaluate the durability, efficacy and safety of KSI-301 in treatment-naïve patients with DME.
Both the GLEAM and GLIMMER studies will randomize participants to receive either intravitreal KSI-301 or Eylea (aflibercept). Patients who are selected to receive KSI-301 will be dosed every 8 to 24 weeks following three loading doses, while patients receiving Eylea will be dosed every 8 weeks after five loading doses. Although the patients in both studies will be treated and followed for two years, the primary endpoint for the two studies is at one year.
Shares of Kodiak Sciences were up 3% following the announcement. Yet, the stock has plunged 58.7% in the trailing 12 months in comparison with the industry’s 40.1% decline.
Apart from DME, Kodiak is also evaluating the KSI-301 for treating various retinal vascular diseases.
Kodiak is conducting a pivotal phase IIb/III DAZZLE study evaluating KSI-301 in patients with treatment-naïve wet-age-related macular degeneration (wet AMD). A phase III BEACON study is also evaluating KSI-301 to address macular edema due to retinal vein occlusion (RVO).
Similar to the GLEAM and GLIMMER studies, both the DAZZLE and BEACON studies have also completed enrolment. Kodiak expects to report top-line data from the DAZZLE and BEACON studies in first-quarter 2022 and mid-2022, respectively.
Kodiak is also evaluating KSI-301 in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME.
The company is also enrolling participants in a phase III DAYLIGHT study, which will evaluate the safety and efficacy of high-frequency KSI-301 in patients with treatment-naïve wet AMD.
Kodiak remains on course to file a single biologics license application for KSI-301 to treat wet AMD, DME and RVO. Data from all these studies are expected to be included in the initial BLA for KSI-301.
Given lucrative market opportunities, a potential approval for KSI-301 could be a major breakthrough for KOD, which currently lacks a marketed drug in its portfolio. Currently, KSI-301 is the company’s only candidate in Kodiak’s pipeline under clinical development. KOD is currently evaluating other candidates in preclinical studies.
Like KSI-301, Eylea is also an anti-VEGF treatment that has been developed by Regeneron (REGN - Free Report) in collaboration with Bayer‘s (BAYRY - Free Report) HealthCare unit.
Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications including DME, wet AMD and RVO. While Regeneron records net product sales of Eylea in the United States, Bayer records net product sales of Eylea outside the country.
Eylea’s blockbuster sales have put a spotlight on the use of VEGF inhibitor medications for the treatment of retinal indications.
Last September, REGENXBIO (RGNX - Free Report) entered into a collaboration deal with pharma giant AbbVie to co-develop and co-commercialize RGX-314, an investigational one-time gene therapy for the treatment of wet AMD and other chronic retinal diseases.
Per the agreement terms, REGENXBIO will receive $370 million as an upfront payment from AbbVie. REGENXBIO will further be eligible to receive potential milestone payments up to $1.38 billion. The deal was closed in November 2021.
Kodiak Sciences Inc. Price
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Zacks Rank
Kodiak Sciences currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.