Outpatient treatment for portal hypertension

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43DK085754-01
Agency Tracking Number: DK085754
Amount: $223,422.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NIDDK
Solicitation Number: PHS2010-2
Small Business Information
DUNS: 167580682
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (206) 860-6769
Business Contact
Phone: (206) 860-6769
Email: ebolotin@pharmain.com
Research Institution
DESCRIPTION (provided by applicant): Portal hypertension (increased pressure in the portal venous system) is one of the main consequences of cirrhosis. Although the reduction of portal hypertension is well documented to prevent the development of life-threatening consequences, including bleeding esophageal varices and hepatorenal syndrome (HRS), pharmacological treatment options are severely limited. The synthetic peptide drug terlipressin has been used in Europe for the past twenty years as one of the safest, most cost-effective and economical drugs to reduce portal hypertension and treat bleeding varices and hepatorenal syndrome. However, its short half life necessitates its administration by IV 4-6x daily, limiting its application to the acute care setting. Our long term goal, in collaboration with our commercialization partner LAT-Pharma LLC, is to develop a long-acting formulation of terlipressin that can be ideally administered by sub-Q injection allowing for once daily administration for the management of portal-hypertension. The aims of the Phase I project are directed toward demonstrating that formulation of terlipressin with our proprietary nanocarrier affords an increase in half-life and a sustained release of the active agent with a prolonged pharmacological effect in vivo compatible with once-daily dosing. Terlipressin is currently not approved in the US and the envisioned drug candidate would have a significant market opportunity both in the acute care setting for life-threatening consequences of portal hypertension, and in the outpatient setting for the prophylactic treatment of portal hypertension. PUBLIC HEALTH RELEVANCE: The envisioned drug candidate is expected to be the first agent available that will allow cirrhotic patients and their physicians reduce portal hypertension in the outpatient setting, thereby avoiding emergency treatment of life-threatening bleeding variceal ruptures and Hepatorenal syndrome.

* information listed above is at the time of submission.

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