An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Rencofilstat in Healthy Male Subjects

This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of [14C] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.

Start Date01 Mar 2023

Sponsor / Collaborator

Hepion Pharmaceuticals, Inc.

NCT05402371

/ Active, not recruitingPhase 2

A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Start Date15 Oct 2022

Sponsor / Collaborator

Hepion Pharmaceuticals, Inc.

NCT05461105

/ CompletedPhase 2

ALTITUDE NASH: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis Stage 3 Fibrosis

This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Start Date15 Mar 2022

Sponsor / Collaborator

Hepion Pharmaceuticals, Inc.

100 Clinical Results associated with Hepion Pharmaceuticals, Inc.

0 Patents (Medical) associated with Hepion Pharmaceuticals, Inc.

Literatures (Medical) associated with Hepion Pharmaceuticals, Inc.

01 Mar 2025·Liver International

Rencofilstat Treatment Improves Liver Function in MASH With Advanced Fibrosis as Quantified by HepQuant DuO

Article

Author: Foster, Robert ; Zhao, Caroline ; Mayo, Patrick ; McRae, Michael P. ; Canizares, Carlos ; Harrison, Stephen A. ; Everson, Gregory T. ; Helmke, Steve M. ; Hobbs, Todd

ABSTRACT:

Background and Aims:

Rencofilstat inhibits cyclophilin to reduce hepatic inflammation and fibrosis, which, in turn, could improve liver function and reduce portal‐systemic shunting. Since HepQuant quantifies liver function and portal‐systemic shunting, it was used to measure the hepatic effects of rencofilstat treatment of MASH with advanced fibrosis.

Methods:

Seventy subjects with suspected ≥ F3 MASH, defined from liver biopsy or AGILE 3+ ≥ 0.53, were randomised to rencofilstat 75 mg/d (n = 24), 150 mg/d (n = 23) or 225 mg/d (n = 23), and tested by HepQuant at baseline, 60 and 120 days. The DuO version included oral dosing of d4‐cholate and two blood samples (20 and 60 min). DuO's disease severity index (DSI) and portal‐systemic shunting fraction (SHUNT%) were evaluated for changes from baseline at 60 and 120 days of rencofilstat treatment.

Results:

Across all subjects, there was a significant decrease in SHUNT% both at Day 60 (−1.67%, p = 0.0156) and Day 120 (−1.55%, p = 0.0441). In the 225 mg rencofilstat arm, 56% of subjects (10/18) were responders by Day 120 (p = 0.0549), and their DSIs improved with a mean change of −1.61 (p = 0.0190). Across all treatment arms, subjects with DSI > 18.3 at baseline had the greatest improvement with treatment (ΔDSI = −2.59, p = 0.0053).

Conclusion:

Although further studies are warranted, the decreases in DSI and SHUNT% suggest that rencofilstat 225 mg/d improves hepatic function and portal‐systemic shunting. HepQuant DuO is simple to administer, well‐tolerated and a useful tool for detecting the hepatic effects of treatment.

Trial Registration:

The study was registered at ClinicalTrials.gov, NCT05461105

01 Dec 2022·Hepatology communications

Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single‐blind, placebo‐controlled study in F2/F3 NASH

Article

Author: Ure, Daren R. ; Mayo, Patrick R. ; Hobbs, Todd M. ; Greytok, Jill A. ; Zhao, Caroline ; Foster, Erin P. ; Canizares, Carlos ; Harrison, Stephen A. ; Trepanier, Daniel J. ; Foster, Robert T.

Abstract:

Rencofilstat (RCF) demonstrated antifibrotic effects in preclinical models and was safe and well tolerated in Phase 1 studies. The aim of this Phase 2a study was safety, tolerability, pharmacokinetics, and exploration of efficacy biomarkers in subjects with nonalcoholic steatohepatitis (NASH). This Phase 2a, multicenter, single‐blind, placebo‐controlled study randomized 49 presumed F2/F3 subjects to RCF 75 mg once daily (QD), RCF 225 mg QD, or placebo for 28 days. Primary safety and tolerability endpoints were explored using descriptive statistics with post hoc analyses comparing active to placebo groups. Pharmacokinetics were evaluated using population pharmacokinetics methods. Efficacy was explored using biomarkers, transcriptomics, and lipidomics. RCF was safe and well tolerated, with no safety signals identified. The most frequently reported treatment‐emergent adverse events were constipation, diarrhea, back pain, dizziness, and headache. No clinically significant changes in laboratory parameters were observed, and RCF pharmacokinetics were unchanged in subjects with NASH. Alanine transaminase (ALT) reduction was greater in active subjects than in placebo groups. Nonparametric analysis suggested that ALT reductions were statistically different in the 225‐mg cohort compared with matching placebo: −16.3 ± 25.5% versus −0.7 ± 13.4%, respectively. ProC3 and C6M reduction was statistically significant in groups having baseline ProC3 > 15.0 ng/ml. RCF was safe and well tolerated after 28 days in subjects with presumed F2/F3 NASH. Presence of NASH did not alter its pharmacokinetics. Reductions in ALT, ProC3, and C6M suggest direct antifibrotic effects with longer treatment duration. Reductions in key collagen genes support a mechanism of action via suppression and/or regression of collagen deposition. Conclusion: These results support advancement of rencofilstat into a larger and longer Phase 2b study.

01 Nov 2020·EndocrinologyQ2 · MEDICINE

Differential Effects of Voclosporin and Tacrolimus on Insulin Secretion From Human Islets

Q2 · MEDICINE

Article

Author: Panzhinskiy, Evgeniy ; Kolic, Jelena ; Overby, Peter ; Johnson, James D ; Ure, Daren R ; Beet, Leanne ; Cross, Jennifer L ; Cen, Haoning Howard ; Huizinga, Robert B

Abstract:

The incidence of new onset diabetes after transplant (NODAT) has increased over the past decade, likely due to calcineurin inhibitor–based immunosuppressants, including tacrolimus (TAC) and cyclosporin. Voclosporin (VCS), a next-generation calcineurin inhibitor, is reported to cause fewer incidences of NODAT but the reason is unclear. While calcineurin signaling plays important roles in pancreatic β-cell survival, proliferation, and function, its effects on human β-cells remain understudied. In particular, we do not understand why some calcineurin inhibitors have more profound effects on the incidence of NODAT. We compared the effects of TAC and VCS on the dynamics of insulin secretory function, programmed cell death rate, and the transcriptomic profile of human islets. We studied 2 clinically relevant doses of TAC (10 ng/mL, 30 ng/mL) and VCS (20 ng/mL, 60 ng/mL), meant to approximate the clinical trough and peak concentrations. TAC, but not VCS, caused a significant impairment of 15 mM glucose-stimulated and 30 mM KCl-stimulated insulin secretion. This points to molecular defects in the distal stages of exocytosis after voltage-gated Ca2+ entry. No significant effects on islet cell survival or total insulin content were identified. RNA sequencing showed that TAC significantly decreased the expression of 17 genes, including direct and indirect regulators of exocytosis (SYT16, TBC1D30, PCK1, SMOC1, SYT5, PDK4, and CREM), whereas VCS has less broad, and milder, effects on gene expression. Clinically relevant doses of TAC, but not VCS, directly inhibit insulin secretion from human islets, likely via transcriptional control of exocytosis machinery.

121

News (Medical) associated with Hepion Pharmaceuticals, Inc.

25 Jun 2025

·hepionpharma.com

Hepion Pharmaceuticals Successfully Completes Application to the OTCQB

MORRISTOWN, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (OTCQB:HEPA), a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC), today announced that it has successfully completed the process of transitioning to the OTCQB Venture Market. The Company’s common stock begins trading on the OTCQB Venture Market today, June 25, 2025 with the trading symbol, HEPA. About Hepion Pharmaceuticals Hepion is a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma. For further information, please contact: Hepion Pharmaceuticals info@hepionpharma.com

Diagnostic Reagents

12 May 2025

·hepionpharma.com

Hepion Pharmaceuticals Announces Receipt of Delisting Notification from Nasdaq

MORRISTOWN, N.J., May 12, 2025 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases which has transitioned to a developer and distributor of diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori and HCC, today announced that on May 9, 2025, the Company received written notice (the “Notice”) from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standards. As previously disclosed, the Company has not been compliant with the requirements under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share and Nasdaq Listing Rule 5101 indicating that Nasdaq believes the Company is a public shell. The Notice indicated that trading in the Company’s shares of common stock (the “Common Stock”) on Nasdaq will be suspended effective at the open of trading on Tuesday, May 13, 2025. Upon suspension of the trading of its Common Stock on Nasdaq, the Company expects that its Common Stock will be quoted under its existing symbol “HEPA” on the OTC Markets Group. About Hepion Pharmaceuticals Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. On May 9, 2025, Hepion entered into a license agreement with New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Hepion Pharmaceuticals info@hepionpharma.com

Phase 2License out/in

07 May 2025

·www.globenewswire.com

Hepion Pharmaceuticals Executes Binding Letter of Intent with New Day Diagnostics to Commercialize Diagnostic Tests for Celiac Disease, Respiratory Multiplex, H. Pylori and HCC

MORRISTOWN, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a binding letter of intent (“LOI”) with New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time. The diagnostic tests covered under the LOI represent a combined addressable market exceeding $15 billion. The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion market, growing at 6.6% annually through 2029, by enabling efficient, simultaneous detection of COVID-19, Influenza A/B, and RSV from a single sample. The H. pylori CE-IVD targets the $700 million market for early, non-invasive detection of infections that can lead to gastric ulcers and cancer, with 6.0% projected growth through 2032. CeliaCare CE-IVD supports rapid screening for celiac disease—an underdiagnosed autoimmune condition—in a $457 million market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma (HCC) in high-risk patients, serves an $8.7 billion market projected to grow 6.7% annually through 2030. Collectively, these diagnostics offer clinical utility across multiple conditions while opening access to meaningful commercial opportunities in global markets. John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion expressed his enthusiasm about this licensing opportunity: “The CE marked tests provide Hepion with the ability to generate near term revenues in European Union countries by leveraging the existing distributor network relationships that New Day Diagnostics has established. We are excited by this opportunity and look forward to working with New Day to maximize value.” “This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world,” said Eric Mayer, CEO of New Day Diagnostics. “We’re excited to partner with Hepion to expand the reach of these CE-marked tests, bring them to the United States, and unlock new opportunities to improve early detection and outcomes across multiple disease areas.” About Hepion Pharmaceuticals Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. Hepion has been considering a number of assets to in-license and develop and Hepion’s Board of Directors believes that the opportunity offered by New Day Diagnostics presents a great opportunity to benefit Hepion’s stockholders. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Hepion Pharmaceuticalsinfo@hepionpharma.com

Phase 2

100 Deals associated with Hepion Pharmaceuticals, Inc.

100 Translational Medicine associated with Hepion Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 15 Nov 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1

Phase 2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Renal Fibrosis(Hepion)	Renal fibrosis More	Preclinical
Cardiac Fibrosis(Hepion)	Myocardial fibrosis More	Preclinical
Idiopathic Pulmonary Fibrosis(Hepion)	Idiopathic Pulmonary Fibrosis More	Preclinical
Rencofilstat ( CYPA x Hepatitis B structural protein x PPIB )	Metabolic Dysfunction Associated Steatohepatitis More	Discontinued
Valnivudine hydrochloride	Acute herpes zoster neuropathy More	Discontinued

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