KSI-301 phase 1b trial : Kodiak Sciences reports new safety, efficacy, and durability data

KSI-301 phase 1b trial : Kodiak Sciences said that its ongoing phase 1b clinical trial of its intravitreal anti-VEGF antibody biopolymer conjugate KSI-301 for the treatment of patients with treatment-naïve wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO), has yielded promising additional safety, efficacy and durability data.

According to the California-based retinal medicines development company, strong anti-VEGF safety, efficacy and durability have been continued to be noted across all the three major retinal vascular diseases.

Kodiak Sciences said that most patients in the phase 1b clinical trial achieved treatment-free intervals of six-months in wet AMD, six-months or longer in diabetic macular edema, and four-months or longer in retinal vein occlusion.

The retinal medicines development company reported that 82% of wet AMD eyes extended to four-months or longer prior to first retreatment, with 68% registering a six-month treatment-free interval.

Also, 76% of DME eyes extended to four-months or longer and 67% extended to six months or longer prior to first retreatment, with almost half of DME eyes yet to need any retreatment after the loading phase.

Kodiak Sciences said that promising safety profile was sustained following 546 doses in 130 patients, with more than 150 patient-years of clinical safety data in the KSI-301 development program.

Victor Perlroth – CEO of Kodiak Sciences, commenting on the KSI-301 phase 1b trial results, said: “The latest Phase 1b study data, where we see the durability of KSI-301 over longer periods of treatment and follow-up, strongly reinforce the potential for KSI-301 to be a foundational anti-VEGF therapy with a durability profile that patients, physicians and payors are asking for.

“We believe that a disruptive ‘Generation 2.0’ anti-VEGF therapeutic would allow nearly all wet AMD and DME patients to be treated on a three-month or longer dose interval and most RVO patients on a two-month or longer interval. Our maturing Phase 1b study data continue to surpass those goalposts. Indeed, for many wet AMD and DME patients, our data suggest KSI-301 may be a once every five- or six-month medicine.”

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