PharmaIN Corporation, a clinical-stage biopharmaceutical company dedicated to developing innovative subcutaneous peptide therapies, 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.

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“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.”

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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.

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“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.

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Source – prweb