Single, subcutaneous injection of PHIN-214 is well tolerated in compensated and decompensated cirrhosis, and yielded preliminary evidence of clinical activity at all dose levels administered.
BOTHELL, Wash., Nov. 18, 2024 /PRNewswire-PRWeb/ -- PharmaIN Corporation, a clinical-stage biopharmaceutical company dedicated to developing innovative subcutaneous peptide therapies, today introduced interim results from its ongoing Phase 1b clinical trial of PHIN-214 for the prevention and treatment of decompensated cirrhosis. Douglas Simonetto, M.D., Mayo Clinic College of Medicine and Science, Rochester, MN presented the findings at the American Association for the study of Liver Diseases (AASLD), The Liver Meeting® on November 18, 2024, in San Diego, CA.
"While the benefits of V1a receptor agonists in reducing portal pressure and increasing renal perfusion in cirrhosis are well known, we currently are limited to frequent or continuous intravenous options for our patients" said Dr. Simonetto. "PHIN-214 is a partial V1a receptor agonist that offers a subcutaneous once-daily option that may allow for chronic self-administration outside hospital settings."
Key findings presented at the Liver Meeting include:
- A total of 6 single ascending dose levels of PHIN-214 have been administered in a total of n=13 subjects (as of November 5th, 2024).
- The emerging PK profile supports QD dosing with little predicted accumulation.
- An improvement in eGFR (estimated glomerular filtration rate) was observed in the majority of subjects, with a median 28.5% improvement at 8 hours being sustained at 14.8% by 24 hours following a single dose of PHIN-214.
- No treatment-emergent dose-limiting toxicities, serious adverse events or incidents of peripheral or central ischemia have occurred.
- Single, subcutaneous injection of PHIN-214 is well tolerated in compensated and decompensated cirrhosis, and yielded preliminary evidence of clinical activity at all dose levels administered.
- These emerging data support further development of PHIN-214 as a self-administered, SC, QD injection for treatment of complications of portal hypertension in patients with decompensated cirrhosis.
"We are enormously excited to present the first clinical data from our PHIN-214 development program. These preliminary data are promising and support the continued development of PHIN-214 as a new potential self-administered treatment option for patients with advanced cirrhosis complications," said Andy Stubbs, PhD, Chief Development Officer.
Poster details:
Abstract Title: PHIN-214: Phase 1 study in compensated and decompensated cirrhosis patients – a novel treatment to manage complications of portal hypertension with subcutaneous, once-daily self-administration.
Authors: Douglas A. Simonetto, MD [1], Naim Alkhouri, MD [2], Ethan Weinberg, MD, MS [3], Philipp Schwabl, MD, PhD [4], Anita Kohli, MD [2], Michael Porayko, MD [5], Eric Lawitz, MD [6]
[1] Mayo Clinic College of Medicine and Science, Rochester, MN; [2] Arizona Liver Health, Chandler, AZ; [3] University of Pennsylvania, Philadelphia, PA; [4] Medical University of Vienna, Vienna, Austria; [5] Vanderbilt University, Nashville, TN; [6] Texas Liver Institute, San Antonio, TX
Abstract Number: 4100
Poster is available on the For Partners page of PharmaIN website.
About PHIN-214:
PHIN-214 is an optimized vasopressor therapy targeting a clinically validated mechanism of action enabling safe, subcutaneous administration and broad application for the prevention and treatment of decompensated cirrhosis. PharmaIN is currently enrolling patients in its ongoing Phase 1b clinical trial evaluating PHIN-214 in cirrhosis (NCT05490888).
About PharmaIN:
PharmaIN Corporation is a clinical stage biopharmaceutical company dedicated to developing first- and best-in-class subcutaneous therapies through its proprietary peptide engineering platform. Through the Company's expertise in target-specific biology, peptide drug design and innovative drug delivery, PharmaIN is developing novel treatments for patients with advanced cirrhosis and cancer. To learn more, visit us at www.pharmain.com.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Business Development inquiries: [email protected]
Media Contact
Akiko Nishimoto-Ashfield, PharmaIN Corp., 1 2065681450 *103, [email protected], www.pharmain.com
SOURCE PharmaIN Corp.
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