With a lead opthalmology drug program well into Phase III, Cambridge, MA-based startup Kala Pharmaceuticals has rounded up a whopping $68 million venture round designed to fuel a push through a set of late-stage trials and on to the FDA next year.
The brainchild of the ubiquitous MIT Professor Bob Langer -- and some former students -- Kala moved swiftly from a launch with preclinical animal data to late-stage testing in three years, a major accomplishment for any biotech.
Langer—a serial biotech entrepreneur with more than 30 startups to his credit — tells me today that the goal is to complete several Phase III studies for indications like inflammation and dry eye. After that, Kala may consider an IPO or some deals, he adds.
“The key issue is to get really good Phase III data for these indications,” he says. And that feeds the hope that the company can be at the FDA’s doors next year with an NDA.
Kala is working in a field that Langer has explored for decades. The lead drug is a nanoparticle formulation of oteprednol etabonate, with the key attribute that it can penetrate the mucosal barrier that protects the eye. And the biotech has gathered human data now that demonstrates its efficacy in treating pain and inflammation after cataract surgery.
In many ways, Kala is a classic Langer startup, with former students playing big roles. Among them is CSO Hongming Chen, a former student of Langer’s.
“She’s fantastic,” says Langer. “I give most of the credit to the people. It’s a great team.”
Mark Iwicki took over as CEO in 2015 after Acorda bought out Civitas, where he had also been CEO.
This latest round brings in some crossover investors, which would be a big assist in any potential IPO.
Longitude Capital led this round, joining a set of new investors that includes OrbiMed, Vivo Capital and CAM Capital. The lineup of existing investors that contributed more to the Phase III round include RA Capital Management, Wellington Management Company LLP, Polaris Partners, and Lux Capital.
“Kala has rapidly transformed into a late-stage ophthalmic company with multiple near-term commercial opportunities for KPI-121,” says Longitude’s Gregory Grunberg in a statement. “Kala’s promising pipeline has the potential to address major markets with large unmet needs and the company has the financial strength, the right team, and the experience to drive its programs toward near-term value creation.”
- here's the release