Tobira Therapeutics and Dong-A said today they have inked a pair of licensing agreements for evogliptin and cenicriviroc (CVC).

The deals are in connection with development programs the companies plan to launch for the combination of the two treatments for patients with nonalcoholic steatohepatitis (NASH). The companies also plan to partner on a global Phase III program for CVC as a single agent for NASH.

“This relationship with Dong-A is an important step toward our goal of developing much needed combination therapies for the millions of patients suffering from NASH and to become the preferred partner for companies seeking to develop NASH therapies,” Tobira CEO Laurent Fischer, M.D., said in a statement.

Dong-A could generate up to $61.5 million-plus under one of the licensing deals, through which Tobira acquired exclusive rights to develop and market evogliptin in combination with CVC and as a single agent in the U.S., Canada, Europe, and Australia for all therapeutic indications.

In return for those rights, Tobira agreed to pay Dong-A $1.5 million in upfront cash as well as potentially up to an additional $25 million tied to achieving Phase III completion and approval milestones for the first indication and up to an additional $35 million for achieving commercial milestones. Dong-A could also receive another $10 million for additional indications.

In the second licensing agreement, Dong-A has received an exclusive license from Tobira to develop and market CVC as both a single agent and in combination with evogliptin in South Korea for all therapeutic indications.

Dong-A paid Tobira $0.5 million cash upfront, and agreed to pay up to an additional $2.5 million tied to achieving milestones per indication in South Korea.

In addition, Dong-A and Tobira will receive tiered royalty payments based on net sales, with each company responsible for its own development costs within its respective territory.

CVC is Tobira’s lead product candidate, a first-in-class immunomodulator and dual inhibitor of C-C chemokine receptor type 2 (CCR2) and CCR5 now under study for the treatment of NASH and human immunodeficiency virus (HIV).

CVC is being evaluated in Tobira’s global Phase IIb CENTAUR study, which is comparing the candidate to placebo in 289 patients with NASH and liver fibrosis. Tobira expects to announce the study’s primary endpoint in the third quarter.

To date, approximately 600 subjects have received CVC in Phase I and Phase IIb clinical studies, including 115 HIV-infected subjects on treatment for up to 48 weeks.

Evogliptin is a potent dipeptidyl peptidase 4 (DPP-4) inhibitor administered as a small 5-mg once-daily tablet. The treatment was launched last month in South Korea under the name Suganon® for blood glucose control in patients with type 2 diabetes.

The companies say a substantial amount of data suggests that the incretin/glucagon-like peptide-1 (GLP-1) pathways targeted by evogliptin are implicated in the progression of nonalcoholic fatty liver disease (NAFLD) and NASH.

According to Tobira, evogliptin has shown compelling preclinical and clinical activity for the treatment of type 2 diabetes and complements the anti-inflammatory and antifibrotic effects of cenicriviroc.

Evogliptin has the potential to be combined in a fixed-dose combination tablet, the company added. Such a combination is intended to address simultaneously the metabolic pathogenesis of NASH and the inflammation and fibrosis that cause liver damage and often lead to cirrhosis, liver cancer, or liver failure.

The companies said Tobira plans to conduct preclinical toxicology and pharmacokinetics studies with evogliptin before initiating a Phase I study of the CVC-evogliptin combination later this year.








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