Business
Kodiak Sciences Announces First Quarter 2022 Financial Results and Recent Business Highlights
PALO ALTO, Calif., May 10, 2022 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and
About this update from Kodiak Sciences Inc
[{"type":"text","content":"PALO ALTO, Calif., May 10, 2022 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today reported business highlights and financial results for the quarter ended March 31, 2022.\n\"We learned in February that our Phase 2b/3 study in wet AMD did not meet its primary endpoint,\" said Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences. \"We have continued to analyze the data from this study and continue to believe that our two primary observations were correct: (a) not allowing treatment more frequent than every 12 weeks (q12w) was a fundamental flaw in the study design and resulted in critical undertreatment in a minority of patients, and (b) the durability with nearly 60% of KSI-301 patients sustained on every five-month dosing while achieving excellent visual and anatomic outcomes is real and represents an important advance in the field. The learnings from this initial study are enabling us to improve the probability of success of the ongoing KSI-301 Phase 3 program, with the anticipation of four Phase 3 study readouts in 2022 and 2023. We remain optimistic that KSI-301 can demonstrate best-in-class durability and meaningfully improve outcomes for patients with common retinal diseases.\"\nRecent Business Highlights\nKSI-301 Clinical Program: As part of the learnings from our initial Phase 2b/3 study in wet AMD, we are implementing changes to our ongoing Phase 3 studies of KSI-301 including changes in the DME program that we believe will mitigate the potential risk of undertreatment in high-need patients and improve the probability of success of these studies. Our regulatory strategy remains intact, and we intend to include data from the BEACON, GLEAM, GLIMMER and DAYLIGHT studies in a single initial BLA, if successful, and would seek labeling at launch that is supportive of a range of indications and dosing intervals.BEACON – Phase 3 Study in Patients with Treatment-Naïve Retinal Vein Occlusion (RVO)The BEACON study design remains unchanged and compares four doses of KSI-301 versus six doses of aflibercept over the 6-month duration to the primary endpoint. The last patient visit for the 24-week primary endpoint is expected in June 2022, and we expect to announce...