|Conatus Initiates Phase 2b Trial of Emricasan in Acute-on-Chronic Liver Failure (ACLF) Patients; XenoPort Announces Inclusion of HORIZANT in the WED Foundation|
|By Staff and Wire Reports|
|Wednesday, 11 September 2013 18:49|
Conatus Pharmaceuticals (Nasdaq: CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced initiation of active patient recruitment in a Phase 2b clinical trial of emricasan in patients with acute-on-chronic liver failure (ACLF). The placebo-controlled, double-blind, multicenter clinical trial is designed to assess the pharmacokinetics and pharmacodynamics of emricasan in patients who have compensated or stable liver cirrhosis and who, at the time of study entry have been hospitalized for at least 24 hours due to acute deterioration of liver function.
"This study marks an important milestone in the development of emricasan and we are excited about the potential of emricasan to address this underserved population in high medical need of an efficacious and well-tolerated therapy to prevent progression to multi-organ failure and, ultimately, premature death," said Dr. Gary C. Burgess, Chief Medical Officer of Conatus.
Conatus plans to use this trial to determine the dose of emricasan to be studied in the planned Phase 3 trial in ACLF. Safety of emricasan in the patient population will be evaluated, and key biomarkers and clinical outcomes will also be explored. The Phase 2b trial is being conducted at approximately 15 centers in the United Kingdom.
There are currently no approved therapies with a specific indication for the treatment of ACLF, which occurs in patients who have compensated or decompensated cirrhosis but are usually relatively stable. In these patients, some acute event sets off a rapid deterioration of liver function. The cause of this acute episode of decompensation may include toxins, such as alcohol, metabolic abnormalities and infections. The morbidity and mortality of the patient population Conatus plans to study is high, and up to 45% of the patients may die, develop multi-organ failure, or require a liver transplant as a result of the decompensation episode within 28 days of hospitalization. The rapid deterioration in liver function, which may be exacerbated by an altered immune response, leads to life-threatening complications such as renal failure, increased susceptibility to infection, hepatic coma and systemic hemodynamic dysfunction. Liver transplantation is required in some subjects to improve survival and quality of life.
In addition to the Phase 2b trial in patients with ACLF, Conatus expects to initiate its planned Phase 2b/3 clinical trial of emricasan in patients who have developed liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT) in the second half of 2013. For additional information about emricasan clinical trials, please visit www.clinicaltrials.gov.
XenoPort, Inc. (Nasdaq: XNPT) announced the inclusion of gabapentin enacarbil, the active ingredient in HORIZANT® (gabapentin enacarbil) Extended-Release Tablets, as an initial therapy for chronic persistent restless legs syndrome/Willis-Ekbom disease (RLS/WED) in an updated treatment algorithm for patients with RLS/WED. The WED Foundation’s algorithm, published in the current issue of Mayo Clinic Proceedings, provides information for physicians determining treatment choices for RLS/WED based on disease severity, existing comorbidities and the long-term benefits and risks of each major class of medications.
The algorithm, first published in 2004, was updated to accommodate several changes in the RLS/WED treatment landscape, including additional knowledge of treatment with nonergot dopamine agonists, increased experience with calcium channel alpha-2-delta ligands and the fact that several long-acting drugs have become available. According to the revised algorithm, either non-ergot dopamine agonists or the calcium channel alpha-2-delta ligands are recommended as initial treatment for patients with chronic persistent RLS/WED, and the choice of the initial treatment should be based on the individual clinical features of RLS/WED in a given patient.
“This is the second publication of clinical guidance in two months that addresses treatment and disease management considerations for RLS/WED, indicating the urgency with which the neuroscience and broader physician communities are seeking to better treat this condition,” said Mark Buchfuhrer, M.D., Medical Director of the Southern California Restless Legs Syndrome Support Group, attending physician at Downey Regional Medical Center in Downey, Calif., and member of the WED Foundation’s Medical Advisory Board and the International RLS Study Group. “This algorithm reflects evidence-based assessments and expert opinion from practical experience, and hopefully will serve as a much needed tool for physicians treating the estimated five million moderate-to-severe RLS/WED patients nationwide.”
“Gabapentin enacarbil is the only non-dopamine agonist and member of the calcium channel alpha-2-delta-ligand class that is approved by the FDA for the treatment of moderate-to-severe primary RLS. We are excited that the updated algorithm recognizes gabapentin enacarbil as an appropriate initial treatment option for patients with chronic persistent RLS/WED,” stated Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, Inc. “XenoPort recognizes that many RLS/WED patients have their disease for life and is committed to understanding the long-term needs of these patients.”
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Conatus Pharmaceuticals (Nasdaq: CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced initiation of active patient recruitment in a Phase 2b clinical trial of emricasan in patients with acute-on-chronic liver failure (ACLF).
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