Tioga Pharmaceuticals, a virtual company based in San Diego with just two fulltime employees, is announcing today it has raised $18 million in private equity to fund a late-stage clinical trial of asimadoline, its experimental drug for irritable bowel disorder.
A new investor, Genesys Capital Partners of Toronto, joined current stakeholders Forward Ventures, New Leaf Venture Partners, and BB Biotech Ventures in the financing.
Tioga says in a press release that the clinical trial of 600 subjects is scheduled to begin in the U.S. next month. The study is one of two randomized, double-blind, placebo-controlled trials required for FDA approval, the company says. The trial is specifically for patients with the form of irritable bowel syndrome that causes diarrhea (D-IBS).
As I reported in last fall, Tioga acquired asimadoline from Germany-based Merck, which put the drug through early-stage trials before deciding it did not fit into Merck’s long-range plans. In return for equity in Tioga, Merck granted the startup rights to asimadoline and agreed to provide project management expertise. Taking Merck’s R&D costs into account, more than $100 million has been invested in the drug.
As a virtual company, Tioga outsources all aspects of clinical development—human trials, chemistry, and manufacturing, regulatory, legal and IP management—in a business model that reduces its financial risk by keeping overhead to a minimum as development progresses from one phase to the next. Team members are on contract and are scattered all over the country.
Tioga describes asimadoline as an oral drug that targets kappa opioid receptors found in the digestive tract. In a mid-stage trial of 596 men and women with D-IBS accompanied by at least moderate pain, asimadoline reduced pain, urgency, frequency and bloating, the company says.
Tioga Chairman and CEO Stuart Collinson, who is also a partner at San Diego’s Forward Ventures, told me last fall that the drug was a good bet because the potential market was fairly large and the only approved drug for the condition, alosetron hydrochloride (Lotronex), carries a black-box warning, the strongest possible, and may only be prescribed by physicians enrolled in a prescribing program that requires them to inform patients about the drug’s risks.
Tioga is now a step closer to learning whether its bet will pay off.