Many patients with the more severe form of age-related macular degeneration, a type of vision loss, have trouble with the standard treatment—a once-monthly injection into the eye.
Kodiak Sciences believes it can do better with an experimental drug that may require less frequent injections and the company has filed for an IPO to finance a slate of global clinical studies. Palo Alto, CA-based Kodiak set a preliminary $100 million target for its stock offering. The company has applied for a listing on the Nasdaq exchange under the stock symbol “KOD.” (Kodiak is not to be confused with Cambridge, MA-based Codiak BioSciences.)
Age-related macular degeneration (AMD) is a chronic eye disease that leads to blurry eyesight or a blind spot in the field of vision. It’s the leading cause of vision loss and blindness among those 50 and older in the U.S., according to the National Eye Institute. “Dry” AMD is a thinning of the macula, the part of the retina responsible for a person’s central line of vision. In the rarer, but more severe “wet” AMD, abnormal blood vessels leak blood or fluid into the macula. This blood vessel growth is sparked by a protein, vascular endothelial growth factor (VEGF). Anti-VEGF drugs block this protein and stop the abnormal blood vessels from forming. Two drugs are FDA-approved to treat wet AMD: ranibizumab (Lucentis) from Roche’s Genentech division, and aflibercept (Eylea) from Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN). Another Roche drug, the cancer drug bevacizumab (Avastin), is frequently used off-label to treat wet AMD.
The Roche and Regeneron anti-VEGF drugs are big sellers: ranibizumab tallied $1.45 billion in 2017 sales, while aflibercept accounted for $3.7 billion in sales last year. But based on a report last year from the Angioenesis Foundation, Kodiak believes the monthly injections are a high burden for patients, leading physicians to extend the treatment interval, making the injections less effective.
Kodiak’s lead drug candidate, KSI-301, is a monoclonal antibody that blocks VEGF and is engineered to remain stable in the eye longer. Kodiak says KSI-301 could be more durable than the Roche and Regeneron AMD drugs.
A Phase 1 clinical trial started in July. The company reported no side effects in the nine-patient study, which tested three doses of the drug. Kodiak says in its prospectus a Phase 2 clinical trial testing its drug is expected to start early next year in approximately 400 patients who have wet age-related macular degeneration. The study will test the highest dose of the Kodiak drug at 16-week intervals, compared to Roche’s aflibercept given every eight weeks. If this study succeeds, the FDA has indicated it could be one of the two pivotal studies needed to support an application for regulatory approval, according to Kodiak. The company is also planning to start a Phase 2 studies in diabetic retinopathy in the U.S., Europe, and China, as well as an AMD study in China.
Kodiak was founded in 2009. The company has raised more than $50 million, including a $34 million Series B round financing in 2016 that included the Dustin A. Moskowitz Trust and affiliates of Baker Bros. Advisors. In April, the company raised $33 million by selling convertible notes to Perceptive Advisors, ArrowMark Partners, and earlier investors. Kodiak spent $22 million on research and development in 2017, a 57 percent increase over the prior year. As of June 30, Kodiak had $17.6 million in cash, according to the filing.
Public domain image of age-related macular degeneration by Flickr user National Eye Institute