Tiny Tioga attracts $10m and new investor for Phase III asimadoline clinical trial
This article was originally published in Scrip
The four-person virtual biotechnology company Tioga Pharmaceuticals Inc. gained another $10 million in a Series B equity financing to fund its ongoing Phase III clinical trial for asimadoline to treat diarrhoea-predominant irritable bowel syndrome (D-IBS).
The San Diego-based firm licensed the oral kappa opioid receptor agonist from Merck in 2005 and has raised $24 million in venture capital and $28 million in equity financing since then, including the recent cash infusion that included $8 million from Thomas, McNerney & Partners.
Dr Jason Brown, a principal with the health care private equity firm, joined Tioga's board of directors.
"We had a lot of investor interest. Thomas, McNerney is a good investor to have, not just in capital, but in thoughtful direction for the company. We wanted to make sure we had a constructive board," said Tioga chairman and CEO Dr Stuart Collinson.
Tioga will start its second Phase III clinical trial for asimadoline after it reports data from the first Phase III study sometime next year. The drug showed an attractive safety profile and significant efficacy for patients with moderate to severe D-IBS in a Phase IIb study.
The US FDA granted a special protocol assessment for asimadoline's two Phase III trials in April 2010 and in June 2011 gave the drug fast track status, a designation granted to expedite the review of new drugs that treat serious or life threatening conditions and address unmet needs.
Also in June 2011, Tioga strengthened its patent protection for asimadoline with a new US patent that covers the drug's use in D-IBS through at least 2028.
"A lot of the risk has already been removed from this programme," Dr Collinson said.
D-IBS has a high unmet medical need, because there are few safe and effective treatments for the 4 million or so D-IBS sufferers in the US and Europe.
GlaxoSmithKline's Lotronex (alosetron HCI, licensed to Prometheus Laboratories) for women with severe D-IBS has a black box warning for serious gastrointestinal adverse reactions, including ischemic colitis and complications of constipation. Also, the generic loperamide can cause hepatic encephalopathy.
In Tioga's Phase IIb study, D-IBS patients with at least moderate pain had a 27% improvement in the number of months with adequate relief of IBS pain compared to placebo (47 percent vs. 20 percent, p=0.011) on a 0.5 mg dose of asimadoline. No adverse events were reported in the randomized, double-blind, dose-ranging clinical trial with 596 patients with D-IBS and alternating IBS
"We are focused on the US, but we are building our understanding of what will be required in Europe," Dr Collinson said.
To date, Tioga has just one partnership agreement in place for asimadoline. Ono Pharmaceutical Co. Ltd. holds the license for Japan, South Korea and Taiwan. Terms of the 2009 license agreement were not disclosed.