SANTA MONICA, CA / ACCESSWIRE / October 22, 2019 / BioVie Inc. (OTCQB:BIVI) ('BioVie' or the 'Company'), a clinical-stage company developing innovative drug therapies for liver disease, announced today that it has submitted for assessment by the U.S. Food and Drug Administration ('FDA') the Phase 2b/3 clinical trial protocol for using BIV201 (continuous infusion terlipressin) to treat ascites due to chronic liver cirrhosis in patients who are refractory to or cannot tolerate diuretic therapy.
In April 2019, BioVie reported the top-line results for its Phase 2a clinical trial of BIV201 for the treatment of refractory ascites. The following results were observed:
Continuous infusion of terlipressin via portable infusion pump was maintained for 28 days in three patients with refractory ascites, and all patients remained hemodynamically stable during treatment.
The steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations.
Four of the six patients treated with BIV201 experienced an increase in the number of days between paracenteses ranging from 71% to 414% compared to prior to initiating therapy.
The Company's new Phase 2b/3 trial protocol, which was designed after written and verbal communications with the FDA, will seek to confirm these results in a much larger multi-center, randomized and controlled Phase 2b/3 clinical trial.
'There is a desperate need for an effective drug therapy for ascites patients that no longer benefit from diuretics and require frequent large volume paracentesis procedures,' said Patrick Yeramian, MD, BioVie's Chief Medical Officer. 'We are excited to advance our novel drug candidate into late-stage development to address this need.' Large volume paracentesis is the withdrawal of 5 or more liters of fluid from the abdomen, typically every 1 to 2 weeks, using a large-bore needle.
The clinical study is titled: A Phase 2b/3 Randomized Study of BIV201 Continuous Infusion in Addition to Standard of Care Compared to Standard of Care to Reduce the Recurrence of Ascites in Patients with Refractory Ascites Secondary to Decompensated Liver Cirrhosis. The clinical trial is planned to begin as early as December 2019 with a lead-in phase, consisting of approximately 12 ascites patients, for the testing of a new ascites symptom assessment tool for patient reported outcomes (PRO). A data readout is anticipated in early 2020 which will be used to support further discussions with the FDA.
Following the completion of the initial lead-in study, BioVie is planning to commence a randomized, controlled clinical trial with approximately 120 subjects at up to 15 US study sites. The currently anticipated primary completion date is July 2021. The proposed co-primary endpoints in the BIV201 treated group compared to the control group over 28 days are: 1) time to recurrence of large volume paracentesis, and 2) cumulative volume of ascites fluid removed. Proposed secondary outcome measures include the emergence of Grade 2 severity complications of liver cirrhosis and the change in patient reported outcomes (an exploratory endpoint). A summary of this study is available on www.clinicaltrials.gov, trial identifier NCT04112199.
BIV201 (continuous infusion terlipressin) is being investigated as a potential new therapy for patients suffering from ascites, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications of advanced liver cirrhosis. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. BIV201 has received Orphan Drug designations for the treatment of ascites and for HRS, has FDA Fast Track status, and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.
About Liver Cirrhosis, Ascites, and Hepatorenal Syndrome
Chronic liver cirrhosis and its complications are the eighth leading cause of death in the US (Runyon 2013). Patients with cirrhosis and ascites account for an estimated 116,000 US hospital discharges annually with frequent early readmissions. Those requiring paracentesis (physical removal of ascites fluid with a large-bore needle) experience an average hospital stay lasting 8 days and generate approximately $5 billion in medical costs (HCUP Nationwide Readmissions Database 2016). Cirrhosis results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is the most common serious complication of advanced liver cirrhosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as the ascites worsens. At this stage, known as refractory ascites, patients often progress to hepatorenal syndrome (HRS) which is the onset of kidney failure and requires emergency hospitalization. Refractory ascites survival is reported to be only approximately 50% at six months (Moreau 2004) and 33% at one year (Planas 2006). Nor have any drug therapies been approved specifically for treating HRS, and about one-half of these patients typically succumb within only 2 - 4 weeks.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as 'anticipates,' 'believes,' 'hopes,' 'estimates,' 'looks,' 'expects,' 'plans,' 'intends,' 'goal,' 'potential,' 'may,' 'suggest,' and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or successfully completing pre-clinical testing or clinical studies, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. BioVie cannot guarantee the effectiveness of its patents or Orphan Drug designations. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
SOURCE: BioVie Inc.
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