If you need an effective drug today for age-related macular degeneration, the leading cause of blindness in the elderly, you need to get an injection at the back of the eye.
Waltham, MA-based Kala Pharmaceuticals believes it may be able to get the drug where it needs to go, without sticking a needle in your eye.
Kala is announcing today it has corralled $11.5 million in a Series A venture financing to support its new ophthalmology drug development strategy. The financing was led by a new firm, Crown Venture Fund, and includes all of Kala’s seed round investors—Lux Capital Management, Polaris Venture Partners, and Third Rock Ventures. The company, founded in 2009 by MIT’s Bob Langer, Johns Hopkins’ Justin Hanes and former Johnson & Johnson executive Colin Gardner, has raised a total of $22.7 million between its seed and Series A financings.
The founding idea at Kala was to deliver drugs efficiently through the mucosal barriers that protect the eyes, the lungs, the gastrointestinal tract, and the vaginal tract. More than a decade of research went in to figuring out how to create substances that could mimic some of the properties of viruses that naturally pull off this tricky feat of biophysics, says CEO Guillaume Pfefer. The task in the early days at Kala was to show that it could make its drug delivery technology work in those different anatomical environments, in animals.
The eyes are an obvious place for a company in Kala’s position to start, as Genentech’s ranibizumab (Lucentis) and bevacizumab (Avastin) and Regeneron Pharmaceuticals’ afilbercept (Eylea) have become hit products for the so-called “wet” form of age-related macular degeneration, in which blood vessels leak behind the eye and obscure vision. For starters, it’s a big market. Approximately 1.5 million people in the U.S. have wet age-related macular degeneration, and the numbers are expected to grow as the baby boomers get older. The global market for wet AMD therapies currently is currently worth about $4 billion a year, according to data from the market research firm IMS Health.
While those products have represented a significant advance for the treatment of the disease, they all need to be injected, and some of the new treatments in development are raising the possibility of adding new kinds of injections to the course of treatment. Kala is hoping its “mucosal penetrating product” platform, which uses a gel-like substance, will be able to deliver an effective drug for wet AMD, and also a common corticosteroid anti-inflammatory that’s used to help people recover from cataract surgery.
Besides the additional shot of cash, Kala is announcing today it has hired Kim Brazzell as its chief medical officer. He previously oversaw ophthalmology drug development at Inspire Pharmaceuticals, and at Novartis Ophthalmics.
“We have the means to execute now, with both the money and the expertise right now at Kala,” Pfefer says. “We have a clear strategy, a clear focus.”
Pfefer, a former Sanofi executive, joined the company in June and soon installed a plan in which Kala would focus on the eye drug market first. That’s based on some animal work that Kala has done that shows its technology, in a topical formulation, can migrate from the front to the back of the eye, he says.
This program is still clearly in its early days. Kala is working to develop a chemical compound, in-house, that can inhibit both the vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) that researchers say are important to the advancement of the wet-form of age-related macular degeneration. In parallel, Kala is in talks with other companies about in-licensing some of these dual inhibitor molecules, which it could test in combo with its delivery system.
Kala’s other drug development program is a new formulation of loteprednol etabonate (Lotemax), which is currently marketed by Bausch and Lomb. That drug, a corticosteroid anti-inflammatory, has gone through different iterations as a suspension and a gel, Pfefer says. The drug, scheduled to lose its patent protection from generic competitors in 2014, is marketed for tamping down inflammation after cataract surgery, and for allergies. Kala believes the drug could be more potent in a new formulation, and that it has an opportunity to be the best-in-class compound, Pfefer says.