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a development plan for a fusion protein drug that shuts down the excess production of inflammatory molecules like interferon alpha, which are troublemakers in patients with systemic lupus erythematosus. This disease is known for causing flare-ups in which the immune system attacks healthy tissue like a virus, causing joint damage, and chronic swelling, pain, and fatigue.
The company hasn’t yet filed an application to the FDA to start clinical trials, although it plans to do that by late summer or early fall, Posada says. The first clinical trial will enroll healthy volunteers, and assess safety. The next step will be to run an early-to-mid-stage clinical trial of the drug in lupus patients, assessing safety and effectiveness at a variety of doses, Posada says. That study, estimated to enroll about 50-60 patients, should give Resolve and Takeda a clear sense of whether the drug is doing what it’s supposed to do, tamping down inflammatory biomarkers associated with lupus. That rich dataset should be available by late 2014 or early 2015, and will be the basis for whether Takeda exercises its license option and delivers Resolve investors their desired return.
Part of what’s interesting with this deal is that it validates the strategy Posada proposed, which never depended on pulling off an IPO or a big-ticket acquisition. Back when Resolve started during the depressed economic times of 2010, few venture investors were willing to bet on traditional business models that depended on spending long years and tens of millions in the hope of one day achieving one of those outcomes. If Takeda ends up exercising the option in a couple years, it will be a proof point for the lean-and-mean “virtual” company model, at least as a way to generate returns for investors.
“This is a model that Takeda loves and other pharma companies love,” Posada says. “The nice thing is I don’t need to spend all my time raising money. We’ve got the funding, and we’ve got a great supporter in Takeda. They have the resources to see this through. Now we need to execute on the plan.”