Kodiak Sciences announced promising additional 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 AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), according to a company news release.
The data are presented online today at the American Society of Retina Specialists 2020 Virtual Annual Meeting by Mark Barakat, MD, an investigator in the study and physician at Retina Consultants of Arizona, Phoenix. The study findings presented by Dr. Barakat can be found on the Kodiak Investor Relations website at http://ir.kodiak.com. A live-streamed Q&A panel discussion will be held on Sunday, July 26, 2020, for ASRS Virtual Annual Meeting attendees.
“Now supported by over 100 patient-years of clinical data in the phase 1b study and over 150 patient-years across the KSI-301 development program, we continue to be very encouraged by the safety, efficacy, and durability of KSI-301,” Jason Ehrlich, MD, PhD, Chief Medical Officer of Kodiak Sciences, said in the news release. “In the data presented today for virtual ASRS, we observed that 82% of wet AMD eyes and 76% of DME eyes treated with KSI-301 were extended to four months or longer after the last loading dose before receiving their first retreatment. 68% of wet AMD eyes have achieved a six-month interval at least once during follow-up. In DME, with all patients having now been followed for six months or longer after only three initial loading doses (versus the five required with current standard-of-care), it is remarkable that nearly half of patients have yet to require any retreatment, and two-thirds of our DME patients have gone six months or longer before receiving their first retreatment.”
“Importantly, KSI-301 is well-tolerated, and the safety profile of KSI-301 remains excellent,” continued Dr. Ehrlich. “With 546 doses given in the phase 1a/1b program, only two events of trace to 1+ intraocular inflammation have occurred, the same two cases as reported previously. These events resolved completely, and both patients have gained over five eye chart lines of vision from their baseline (+30 and +27 letters, respectively). The durability of KSI-301 is exceeding my expectations. It is notable that we see very few retreatment injections – in fact, only an average of 1.3 injections were given in the wet AMD patients in the eight months after the loading phase, and only 0.6 injections in DME patients and 1.3 in RVO patients. This compares very favorably to the best current standard-of-care anti-VEGF therapy (4.0, 5.0 and 8.0 injections, respectively). We believe these results strongly support both the disruptive KSI-301 dosing regimens in our pivotal study designs and the studies’ likelihoods of success.”
“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,” said Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences. “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.”