Dong-A ST said on September 12 that Tobira Therapeutics Inc. (CEO Laurent Fischer) has recently initiated conducting a phase 1 study of the combination therapy of Evogliptin and Cenicriviroc (CVC) so as to develop a composite drug of non-alcoholic steatohepatitis (NASH).
In compliance with an agreement with Dong-A ST, Tobira has worked on developing a drug combining Cenicriviroc and Evogliptin for the treatment of NASH, and the company started its first administration last week as it has succeed in getting an approval for a phase 1 study of the CVE- Evogliptin combination therapy from the U.S. Food and Drug Administration (FDA) in August this year.
The phase 1 will be conducted on healthy adults, and evaluate the pharmacodynamics characteristics, safety, and drug tolerance of Evogliptin when it is used in combination with CVC.
Evogliptin, a potent DPP-4 inhibitor for the treatment of diabetes, has high tissue affinity to liver while being highly effective in inhibiting hepatic fat accumulation. Therefore it is expected to create a synergy effect when combined with the antifibrotic effect of CVC in treating NASH.
In the recently released results of phase 2 (CENTAUR study), Cenicriviroc being developed by Tobira shows clinical and statistical significance and proves to be safe and drug tolerant in a year after being administered to improve hepatic fibrosis without worsening steatohepatitis, which is a major evaluation variable.
Tobira will discuss the design of a phase 3 trial with the U.S. FDA this year on the basis of the results before conducting the phase 3 of CVC next year.
“The close cooperation between the two companies allows us to get approval from the U.S. FAC on the phase 1 four months after signing a licensing out contract and to initiate the trial,” said Dong-A ST CEO Kang Soo-hyong, adding, “We will do our utmost to invent Dong-A ST’s second global blockbuster drug following Sivextro.”