Kodiak's KSI-101 shows promising results in macular edema trial

Published 05/11/2025, 13:10
Kodiak's KSI-101 shows promising results in macular edema trial

PALO ALTO - Kodiak Sciences Inc. (NASDAQ:KOD) reported Wednesday that its experimental eye treatment KSI-101 demonstrated significant vision improvements in patients with macular edema secondary to inflammation (MESI) through week 20 of its Phase 1b APEX study. The clinical-stage biopharmaceutical company, currently valued at approximately $954 million, has seen its stock surge over 313% in the past year according to InvestingPro data.

The bispecific antibody therapy, which targets both interleukin-6 and vascular endothelial growth factor, showed that more than half of patients in the top two dose levels (5 mg and 10 mg) achieved improvements of three lines or more on the eye chart. Approximately 90% of patients in these dose groups achieved complete dryness of the retina, as measured by the absence of intraretinal and subretinal fluid.

The 10 mg dose group showed the strongest mean improvement in visual acuity with a 15.4 letter gain on the ETDRS scale, while the 5 mg and 2.5 mg groups achieved gains of 13.4 and 11.8 letters, respectively. Patients in the top two dose groups reached mean visual acuity equivalent to approximately 20/25 vision. These promising results have contributed to Kodiak's impressive 267.89% stock price increase over the past six months, though InvestingPro analysis indicates the stock's movements remain quite volatile.

Anatomical improvements were also substantial, with mean reductions in retinal thickness ranging from 151.2 microns in the lowest dose group to 230.1 microns in the highest dose group.

"The vast majority of the drying effect was already observed at Week 1," noted Dr. Velazquez-Martin, Chief Medical Officer of Kodiak, according to the press release statement.

The company reported that KSI-101 continued to be well tolerated with a favorable safety profile across all dose levels.

Based on these results, Kodiak has advanced the 5 mg and 10 mg doses into Phase 3 studies called PEAK and PINNACLE, which are currently enrolling patients. The company stated that these pivotal trials are progressing at a faster-than-expected pace. Despite this clinical progress, InvestingPro data shows analysts do not expect Kodiak to be profitable this year, with the company currently trading at $18.10 per share, below its Fair Value estimate. Investors should note Kodiak is scheduled to report its next earnings on November 12.

Complete week 24 data from the APEX study will be presented at the Angiogenesis, Exudation, and Degeneration 2026 Annual Meeting on February 7, 2026.

In other recent news, Kodiak Sciences Inc. has seen significant developments that may interest investors. Barclays upgraded the company's stock from Underweight to Equalweight, raising the price target to $17.00, following promising data from the Phase 2 BARDENAS trial. This data showed improved visual acuity in diabetic macular edema patients treated with vamikibart plus ranibizumab. JPMorgan also upgraded Kodiak Sciences from Neutral to Overweight, increasing the price target to $24.00, based on the potential of KSI-101, a treatment for macular edema secondary to inflammation. Jefferies initiated coverage with a Buy rating and a $15.00 price target, citing the company's three drugs in Phase III clinical trials with key readouts expected in 2026. Additionally, Soros Fund Management disclosed a 5.7% stake in Kodiak AI, adding to the interest in the company's activities. These updates reflect a growing confidence among analysts and investors in Kodiak Sciences' future prospects.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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