Kodiak Sciences Announces Positive Interim Data from KSI-301 Phase 1b Clinical Trial, a Novel Anti-VEGF Biopolymer Conjugate for the Treatment of Wet AMD, Diabetic Eye Disease Retinal Venous Retention at the 2019 Annual Meeting of the American Retina Society

PALO ALTO, California, July 27, 2019 / PRNewswire / – Kodiak Sciences Inc. (Nasdaq: KOD), a clinical-stage biopharmaceutical company specializing in new treatments for the treatment of high-prevalence chronic retinal diseases, today announced positive interim results for the phase In progress 1b study of KSI-301, its experimental conjugate biopolymer anti-VEGF intravitreal antibody in patients with neovascular age-related macular degeneration (VMAF) naive anti-VEGF treatment and macular edema due to retinal venous occlusion (OVR).

The results were presented by Pravin U. Dugel, MD, a researcher in the study, gave an oral presentation at the annual meeting of the American Society of Retinal Specialists (ASRS) 2019. Dr. Dugel is Managing Partner, Retinal Consultants of Arizona and Institute of Retinal Research, Phoenix, AZand Clinical Professor, Roski Eye Institute, USC Keck School of Medicine, Los Angeles, CA. The detailed results of the study presented by Mr. Dugel are available on the Kodiak Investor Relations website at http://ir.kodiak.com.

Summary of effectiveness results up to week 12

Of the three diseases under study, strong improvements in vision and retinal anatomy were observed over 12 weeks. Vision is measured as a change in best corrected visual acuity (BCVA) on a standardized eye chart, and retinal anatomy is measured as a change in the thickness of the central retinal subzone ( CST) using optical coherence tomography (OCT) imaging. The efficacy data presented at the ASRS include the results obtained in 35 patients in the study having reached the 12th visit. In the study, patients are treated with three monthly doses of 2.5 mg or 5 mg of KSI-301 and are followed for 7 months, with additional treatments according to the reprocessing criteria defined by the protocol.

The following results were observed at week 12 *:

* Includes patients who have reached the 12th week of visit July 24, 2019 deadline for the transmission of data; Doses of 2.5 and 5 mg combined.

"We are pleased with the promising data on the effectiveness and safety of the KSI-301 to date," said Jason Ehrlich, M.D., Ph.D., Chief Medical Officer and Director of Development, Kodiak. "In addition to visual and anatomical improvements, we have observed encouraging signs of disease modification." In the individual case studies presented at the ASRS, OCT angiography allowed to observe standardization. retinal vascular flow in a patient with OVR seen as early as one week after the first dose and reduction in the size of choroidal neovascularization and vascular flow in a patient with wet AMD: in one patient DME patient with proliferative retinopathy, we observed a conversion to nonproliferative retinopathy and a two-step improvement in the severity score of diabetic retinopathy at the 12-week badessment These findings reinforce our belief about the promise of KSI -301 and the additional potential of our ABC platform.We look forward to presenting emerging data on the sustainability of the phase. 1b study at the American Academy of Retina Ophthalmology day subspecialty on October 11, 2019. "

Summary of security results

A total of 200 KSI-301 injections have been administered to date during Phases 1a and 1b program without intraocular inflammation or serious ocular adverse effects reported.

From July 24, 2019 Deadline for submission of ASRS data, a total of 77 patients were included in the phase 1b study. Exposure to KSI-301 multiple doses was well tolerated. A total of 77 patients received one injection, 60 patients received two injections and 44 patients received three injections. No adverse drug reactions or serious adverse events have been reported. Most reported adverse reactions were mild (70%) and consistent with the profile of intravitreal anti-VEGF agents. Eight serious non-ocular adverse events were reported in four patients, none of which were evaluated as drug-related.

Twelve major retinal research centers in United States participate in the phase 1b study. For more details on the study, please visit https://clinicaltrials.gov/ct2/show/NCT03790852.

Phase 1b Expansion of the test

The sentence 1b The KSI-301 study is about to complete the enrollment of the planned cohorts. Based on the positive data observed to date, Kodiak is planning additional cohorts to explore other scientific issues related to KSI-301 and its use for the treatment of retinal diseases.

Status of the Phase 2 Study "DAZZLE & # 39; on wet AMD

Recruitment in a Phase 2 clinical trial comparing KSI-301 and aflibercept in previously untreated wet AMD patients is expected to begin in the third quarter of 2019. study, called DAZZLE, about 364 patients should be recruited. on a global scale. Patients will be randomized to receive KSI-301 in a regimen as infrequent every 20 weeks, or aflibercept to standard care according to its regimen every 8 weeks. All patients randomized to KSI-301 will follow a regimen every 12 weeks or more after three monthly loading doses.

About the KSI-301

The KSI-301 is an experimental treatment based on the company's ABC platform. It is designed to maintain potent and effective drug levels in ocular tissues longer than existing agents. The goal of Kodiak with KSI-301 is to develop a new first-line agent to improve outcomes in patients with retinal vascular disease and enable faster treatment and prevention of vision loss in patients with Diabetes-related eye disease. The KSI-301 is under development and belongs to Kodiak Sciences Inc. worldwide.

About Kodiak Sciences Inc.

Kodiak ™ is a clinical-stage biopharmaceutical company specializing in novel treatments for the treatment of high prevalence chronic retinal diseases. Our goal is to introduce new scientific knowledge into the design and manufacture of next-generation retinal drugs to prevent and treat the leading causes of blindness worldwide. Our ABC ™ platform merges the fields of antibody-based and chemistry-based therapies and is at the heart of Kodiak's discovery engine. Kodiak's lead product candidate, KSI-301, is a novel biopolymer conjugate of anti-VEGF antibody, currently being developed as a first-line agent for retinal vascular disease, including age-related macular degeneration and eye diseases related to diabetes. Kodiak has leveraged its ABC platform to create a pipeline of product candidates at various stages of development, including KSI-501, our bispecific biopolymer anti-IL-6 / VEGF conjugate for the treatment of neovascular retinal diseases such as AMD. wet and diabetic retinopathy. Kodiak is based in Palo Alto, CA. For more information, visit www.kodiak.com.

Forward-looking statements

This release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933, section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not exhaustive. based on historical fact and include statements about our platform technology and potential therapies, future development plans, clinical and regulatory goals and timing, anticipated design of planned clinical trials the potential effectiveness and commercial potential of our product candidates, including KSI-301, the anticipated presentation of data, the results of our research and development efforts, the anticipated presentation of additional data and our ability to advance our product candidates. subsequent stages of development. Forward-looking statements generally include predictive statements that depend on or refer to future events or conditions, and include words such as "may", "will", "should", "should", " provide "," plan "," believe "," intend "," pursue "and other similar expressions, among others. All forward-looking statements are based on management's current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual and actual results to differ materially and adversely from those expressed in or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, preliminary data on the safety, efficacy and durability of our product candidate KSI-301 will not be maintained or persisted; stopping or delaying any of the ongoing clinical studies and / or the development of KSI-301 may occur; Potential future regulatory milestones for KSI-301, including those related to ongoing and planned clinical studies, may not be sufficient to support regulatory submissions or approvals; the expected presentation of data at future conferences may not occur; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; one or more of our product candidates may not be developed, approved or marketed successfully; adverse conditions in domestic and global economic markets; and other risks identified in our filings with the Securities and Exchange Commission. For more information on other risks and uncertainties, as well as other important factors, that could cause our actual results to differ from those contained in the forward-looking statements, please refer to the section entitled " Risk Factors "of our most recent 10-Q form. as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date they are published and Kodiak badumes no obligation to update such statements. Readers are cautioned not to place undue reliance on these statements.

"Kodiak", "" ABC Platform "and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various jurisdictions.

SOURCE Kodiak Sciences Inc.

Related Links

http://www.kodiak.com