Policy & Regulation
Enanta Pharmaceuticals Completes Enrollment in Two Ongoing Phase 2 Studies
20 March 2019 - - US-based biotechnology company Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA) has completed enrollment in two Phase 2 studies, the company said.

The Phase 2 study of EDP-938 in RSV is a randomised, double-blind, placebo-controlled, human challenge study in healthy adult subjects randomized into 1 of 2 dosing arms or a placebo arm.

Subjects are dosed for 5 days and receive a once-daily 600 mg dose, a single 500 mg loading dose followed by 300 mg twice daily, or placebo. Primary and secondary outcome measures include changes in viral load measurements and changes in baseline symptoms.

Topline data is expected mid-calendar 2019.

The ARGON-1 study in NASH is a 12-week, randomised, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with NASH. The primary endpoint in the study is ALT reduction and safety.

Subjects receive placebo or a 1 mg or 2.5 mg dose once daily for 12-weeks. Topline data is expected by the end of 3Q19.

EDP-938, Enanta's lead N-protein inhibitor, is being developed for the treatment of RSV infection. Enanta believes EDP-938 is differentiated from fusion inhibitors currently in development by others for RSV because this N-protein inhibitor targets the virus' replication machinery and has demonstrated high barriers to resistance against the virus in vitro.

EDP-938 has also been shown to reduce viral load below the level of detection in vivo. Additionally, it is possible that N-protein inhibitors may be effective treatments at later stages of infection.

Respiratory syncytial virus is a virus that infects the lungs and represents a serious unmet medical need in infants and children, as well as immune-compromised individuals and the elderly.

RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States.

Each year, 57,000 to 125,000 children in this group are hospitalized due to RSV infection.

Also, at increased risk of a severe RSV infection, are children with compromised (weakened) immune systems due to a medical condition or medical treatment, adults with compromised immune systems and those 65 and older. There is currently no safe and effective therapy for already established RSV infection.

EDP-305 is a potent FXR agonist and Enanta's lead product candidate being developed for the treatment of NASH and PBC. EDP-305 represents a new class of FXR agonists that has been designed to take advantage of increased binding interactions with the receptor.

Further, this non-bile acid class contains steroidal and non-steroidal components and does not contain the carboxylic acid group that can lead to the formation of taurine and glycine conjugates normally associated with bile acids, which may also be present in other classes of FXR agonists.

Non-alcoholic fatty liver disease (NAFLD) is the accumulation of excessive fat in the form of triglycerides in patients' liver cells (steatosis) that is not associated with alcohol abuse.

NAFLD is widely considered to be the liver expression of metabolic disease associated with type 2 diabetes, insulin resistance, obesity, and hyperlipidemia.

A subgroup of NAFLD patients has liver cell injury and inflammation (steatohepatitis) in addition to excessive fat. Progression of this condition leads to non-alcoholic steatohepatitis.

Patients with NASH can develop fibrosis and ultimately cirrhosis of the liver, potentially leading to hepatocellular carcinoma or requiring a liver transplant. Farnesoid X receptor is a nuclear receptor and a main regulator of bile acid levels in the liver and small intestine.

FXR responds to bile acids by regulating gene transcription of key enzymes and transporters, many of which play important roles in lipid metabolism, insulin resistance, inflammation, and fibrosis.

Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases.

Enanta's research and development efforts are currently focused on the following disease targets: respiratory syncytial virus, non-alcoholic steatohepatitis / primary biliary cholangitis, and hepatitis B virus.

Enanta's research and development activities are funded by royalties from HCV products developed under its collaboration with AbbVie.

Glecaprevir, a protease inhibitor discovered by Enanta, is now sold by AbbVie in numerous countries as part of its newest treatment for chronic hepatitis C virus infection. This HCV regimen is sold under the tradenames MAVYRET and MAVIRET (ex-US) (glecaprevir/pibrentasvir).
Login
Username:

Password: