Interneuron Pharmaceuticals, Inc. has exercised its option and entered into an agreement to license IP 501, an orally-administered anti-fibrotic purified phospholipid compound in Phase 3 development for the treatment and prevention of liver diseases, including alcohol and Hepatitis C-induced cirrhosis.
The license agreement gives Interneuron rights to develop and commercialise the drug in several major markets, including the United States and Japan.
In addition, the Company announced the initiation of a government-funded Phase 3 clinical trial evaluating IP 501 in Hepatitis C. IP 501 is the subject of a recently completed Phase 3 clinical trial funded by the government to evaluate the compound in alcoholic cirrhosis.
The primary endpoint of the study is reduction in the progression of cirrhosis among drug-treated pre-cirrhotic patients compared with placebo patients, as measured by serial liver biopsies.
The Company expects to receive a preliminary analysis of the data in the first quarter of this year.
In addition to this trial, IP 501 is also being studied in another government-funded, multi-centre, Phase 3 clinical trial.
This recently initiated, multi-year trial is designed to evaluate the safety and effectiveness of IP 501 in treating patients with Hepatitis C-associated cirrhosis.
Under the terms of the license agreement, the Company has acquired rights to develop and commercialise IP 501 in the United States, Canada, Japan, Korea, and, under certain circumstances, Europe and other markets.
Interneuron is responsible for all remaining clinical and regulatory development, manufacturing, and marketing of the compound.
Interneuron Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialisation of a diversified portfolio of product candidates, including multiple compounds in late- stage clinical development.