A Phase 1, Two Parts, Open-label, Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt (EYP651) in Healthy Volunteers and Evaluation of Potential Drug-Drug Interactions

The purpose of this study is to define and compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EYP651 at two dose levels and compare it with Vonafexor Acid PK and PD profile, the Part A.
In addition, Part B of the trial will assess the Drug-Drug Interactions (DDI) potential with the high dose of EYP651.

Start Date28 Oct 2025

Sponsor / Collaborator

ENYO Pharma SA

NCT06939816

/ TerminatedPhase 2

A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH

This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.

Start Date01 Jul 2025

Sponsor / Collaborator

ENYO Pharma SA

NCT06425055

/ CompletedPhase 2

Vonafexor Fixed Dose-escalation Safety and Proof-of-concept Study in Patients With at Risk of Progression Alport Syndrome

This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.

Start Date01 Aug 2024

Sponsor / Collaborator

ENYO Pharma SA

100 Clinical Results associated with Vonafexor

100 Translational Medicine associated with Vonafexor

100 Patents (Medical) associated with Vonafexor

Literatures (Medical) associated with Vonafexor

01 Mar 2026·PEDIATRIC NEPHROLOGY

From RAAS blockade to regenerative medicine: evolving treatment strategies in Alport syndrome

Review

Author: Kim, Jin-Ju ; Lo Re, Claudia ; Fornoni, Alessia

Abstract:

Alport syndrome (AS) is a hereditary glomerulopathy caused by mutations in the COL4A3 , COL4A4 , or COL4A5 genes, leading to progressive kidney decline and extrarenal manifestations. Advances in genetic testing have enabled the reclassification of AS into X-linked, autosomal recessive, and autosomal dominant forms, facilitating more accurate diagnosis and risk stratification. While renin-angiotensin-aldosterone system (RAAS) blockade remains the foundation of treatment to delay kidney failure, it does not directly target the underlying molecular pathology. Adjunctive commercially available metabolic modulators, including SGLT2i, mineralocorticoid receptor antagonists, ezetimibe and GLP-1 receptor agonists, may offer additional kidney protection. Ameliorating therapies being tested in Phase II trials include endothelin receptor antagonists (e.g., atrasentan), dual endothelin receptor antagonist and angiotensin II receptor inhibition (e.g., sparsentan) FXR agonists (e.g., vonafexor), inducers of cholesterol efflux (e.g., VAR200 and R3R01), and NOX1/4 inhibitors (e.g., setanaxib), several of which are currently being evaluated in clinical trials. Novel strategies such as exon skipping, gene editing, and nonsense mutation readthrough (e.g., ELX-02) are advancing toward precision medicine approaches as disease modifying agents targeting the genetic cause of AS. Moreover, therapies targeting mitochondrial function, such as mitophagy enhancers, have demonstrated preclinical promise. Stem cell-based approaches are also being explored for their regenerative and anti-fibrotic effects. This review summarizes the current landscape of AS classification and treatment, highlighting both standard interventions and experimental therapies. Emphasis is placed on the molecular mechanisms underlying podocyte injury and fibrosis, recent preclinical findings, and ongoing clinical trials that may shift future therapeutic paradigms. Graphical abstract

21 Sep 2025·BRITISH JOURNAL OF CANCER

New mechanistic understanding of FXR agonist Vonafexor: inducing sublethal damage of HBV-positive liver cancer cells via promoting anti-tumor immunity

Article

Author: Wang, Xiaoqian ; Chen, Siyan ; Ye, Dongjie ; Pan, Banglun ; Yao, Yuxin ; Luo, Yue ; Tang, Nanhong ; Zhang, Zhu ; Zhang, Xiaoxia ; Wu, Hao

BACKGROUND:

In hepatitis B virus (HBV)-infected patients, there's an increase in exhausted T and NK cells, as well as myeloid-derived suppressor cells (MDSCs) in liver, suggesting that boosting immune responses is beneficial. While Vonafexor inhibits HBV transcriptional activity, its effects on the immune microenvironment of HBV-positive hepatocellular carcinoma (HCC) and the mechanisms of immune clearance of these infected cells are not well understood.

METHODS:

In this study, tumor tissues from HBV-positive HCC patients were orthotopically transplanted into the livers of Hu-SRC mice to replicate the tumor microenvironment of the patients. Immunofluorescence, flow cytometry, immunoblotting, and RT-qPCR were used to investigate the mechanism by which Vonafexor promoted sublethal damage of virus-positive HCC cells.

RESULTS:

We found that the therapeutic efficacy of Vonafexor in inducing sublethal damage of HBV-positive HCC cells was attributed to its ability to inhibit CD36-mediated free fatty acid intake and enhance GZMB expression in T and NK cells. This effect was mediated through the downregulation of hepatitis B e antigen, which inhibited mitochondrial ROS, thereby augmenting their cytotoxicity via cGAS-STING-NF-κB signaling. Additionally, Vonafexor blocked c-Rel nuclear entry in MDSCs, reducing their infiltration.

CONCLUSIONS:

Our study indicated that Vonafexor showed potential as an immunotherapy for HBV-positive HCC.

01 May 2025·JHEP Reports

A novel in vitro system for simultaneous infections with hepatitis B, C, D and E viruses

Article

Author: Diaz, Olivier ; Meuleman, Philip ; Wedemeyer, Heiner ; Michelet, Maud ; Salvetti, Anna ; Durantel, David ; Verrier, Eloi R ; Passot, Guillaume ; Verhoye, Lieven ; Doceul, Virginie ; Pons, Caroline ; De Meyer, Amse ; Fouillé, Roxanne ; Rivoire, Michel ; Pavio, Nicole ; Steinmann, Eike ; Lucifora, Julie ; Darteil, Raphaël ; Barnault, Romain

Background & Aims:

The liver, and more precisely hepatocytes, can be infected by several hepatotropic viruses, including HBV, HDV, HCV and HEV, with chronic infection leading to end-stage liver diseases. Since no in vitro model allowing multi-infections with the four viruses is reported, limited data are available on their interplay as well as on the potential cross-reactivity of antivirals in multi-infection cases. The aim of our study was to set up such a model.

Methods:

HuH7.5-NTCP cells were cultured with 2% DMSO (dimethyl sulfoxide) for 1 week to allow partial differentiation into hepatocytes (dHuH7.5-NTCP) before infection with the different viruses and treatment with known antiviral molecules.

Results:

We observed increased expression of liver specific transcripts and production of ApoB containing VLDL in dHuH7.5-NTCP cells and replication of HBV, HDV, HCV and HEV for at least 4 weeks after mono or multiple infections. We recapitulated the known antiviral effect of sofosbuvir on HCV and HEV (>90% reduction in the levels of intracellular viral RNAs, p <0.0005) and of IFN-α on HCV, HEV and HDV (80% reduction in the levels of intracellular viral RNAs, p <0.0005). Besides its already described antiviral effect on HBV and HDV, we observed that GW4064, a farnesoid X receptor (FXR) agonist, also strongly inhibited HEV replication (85 to 95% reduction in the levels of intracellular HEV RNAs, p <0.0005). Using HEV-infected HuHep mice, we confirmed the antiviral effect of vonafexor, an FXR agonist, that is currently being tested clinically against HBV/HDV.

Conclusions:

We set-up the first in vitro model allowing multi-infections with hepatitis viruses that can be used for broad drug screening and highlighted FXR ligands as potential broad-acting antivirals.

Impact and implications:

Hepatitis virus infections caused by HBV, HCV, HDV, and HEV represent a global health threat. Treatment options remain limited, notably due to the lack of knowledge about molecular virus-host interactions. Moreover, the interplay between these four viruses in the context of co-infections remains unknown. In this study, we report the first in vitro system that allows for mono and multi-infections with these four viruses and characterize the broad antiviral activity of farnesoid X receptor agonists, paving the way for the development of new strategies for viral cure.

News (Medical) associated with Vonafexor

02 Jun 2026

·www.biospace.com

ENYO Pharma Appoints Jeff George as Chairman to Support Next Phase of Growth and Phase 3 Readiness

Leadership transition reinforces ENYO’s strategic positioning following positive Phase 2 results with Vonafexor in Alport Syndrome ENYO preparing to enter Phase 3 following planned End-of-Phase 2 meeting with health authorities in Q3 2026 LYON, France--(BUSINESS WIRE)--ENYO Pharma (“ENYO”), a clinical-stage biotechnology company developing innovative therapies for kidney diseases, today announced the appointment of Jeff George as Non-Executive Chairman of its Board of Directors. The appointment comes as ENYO advances preparations for a pivotal Phase 3 program of Vonafexor in Alport Syndrome, a rare kidney disease, following positive Phase 2 clinical results and ahead of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration and the European Medicines Agency during Q3 2026. George’s appointment strengthens ENYO’s governance and strategic capabilities at a key inflection point in the company’s development as it transitions toward late-stage clinical development and broader corporate expansion. Jeff George is a highly experienced global pharmaceutical executive with a proven track record of scaling and leading major biopharmaceutical organizations across North America, Europe and emerging markets. Between 2008 and 2016, Jeff served on Novartis Group Executive Committee, first as the global CEO and Division Head of Sandoz, Novartis’s generic pharma and biosimilar subsidiary, and then as the global CEO and Division Head of Alcon, its ophthalmology subsidiary, both of which are now publicly listed companies. Since 2017, he has served as Managing Partner of Maytal Capital, a healthcare-focused venture capital and private equity firm he founded, and on the board of directors of over a dozen public, private, and non-profit companies and organizations. “ I am excited to join ENYO Pharma at a key inflection point in the company’s evolution ,” said George. “ The clinical data generated to date with Vonafexor are highly compelling and suggest the potential for a differentiated therapeutic approach not only in Alport Syndrome, but potentially across a broader set of kidney diseases driven by inflammation and fibrosis. ENYO is uniquely positioned with a promising clinical asset, a strong scientific foundation, premier global investors, and a clear development strategy as it advances into Phase 3.” Jacky Vonderscher, Chief Executive Officer of ENYO Pharma, commented: “ We are extremely pleased to welcome Jeff as Chairman of the Board during this transformative period for ENYO. His leadership experience in global pharmaceutical companies, as well as his strategic, organizational, and governance expertise, will be invaluable as we prepare the company for Phase 3 development and future expansion. “Over the past three years, I have combined the roles of CEO and Chairman while leading ENYO through critical stages of development. With the strong momentum generated by our Phase 2 results, this is the right time to further strengthen our Board and governance structure. I am delighted to partner with Jeff as we position ENYO for its next phase of value creation.” Vonafexor is being developed as a first-in-class therapy targeting inflammatory and fibrotic pathways involved in kidney disease progression. Beyond Alport Syndrome, ENYO believes the compound may have broader applications across chronic kidney diseases with significant unmet medical need. About Vonafexor Vonafexor is a once-daily, oral, non-bile acid FXR agonist designed with a unique chemical scaffold that prioritizes delivery to the kidney. By regulating metabolic, inflammatory, and fibrotic pathways, Vonafexor addresses the core drivers of renal injury and extracellular matrix remodeling. About ENYO Pharma ENYO Pharma – Developing therapeutics for diseases with impaired kidney function Contacts Investor Relations EnyoPharma Tel: +33 (0)4 37 70 02 19 communication@enyopharma.com Media Relations Annie-Florence Loyer, NewCap Media +33 (0)1 44 71 00 12/ +33 (0)6 88 20 35 59 afloyer@newcap.fr

08 Jan 2026

·www.businesswire.com

ENYO Pharma Announces Completion and Topline Data From Phase 2 Alpestria-1 Clinical Study in Alport Syndrome Demonstrating Vonafexor Reverses Kidney Function Decline and Has Sustained Therapeutic Benefit

LYON, France--(BUSINESS WIRE)--ENYO Pharma (“ENYO”), a clinical-stage biopharmaceutical company developing innovative therapies for kidney diseases, today confirmed positive results from its Phase 2 Alpestria-1 study of vonafexor in patients with Alport syndrome. The data demonstrates that vonafexor, a highly differentiated FXR agonist, produced clinically meaningful improvements on kidney disease progression markers in a high-risk population already receiving standard of care (SoC) therapy. In addition to significantly reducing albuminuria, vonafexor treatment was associated with a reversal of the expected decline in kidney function with durable effects after treatment discontinuation. “The Alpestria-1 results represent a pivotal moment for ENYO and are more importantly a watershed moment for patients living with Alport syndrome” added Jacky Vonderscher, PhD, CEO of ENYO Pharma. Groundbreaking Clinical Data: Reversing the Slope of Decline The Alpestria-1 study enrolled (in France, USA and Spain) 26 patients with Alport syndrome at high risk of a rapid loss of kidney function despite stable multiple SoC drugs, including renin–angiotensin system inhibitors, SGLT2 inhibitors, and mineralocorticoid receptor antagonists. Key findings include: eGFR Slope Reversal: Patients entered the study with a documented historical mean eGFR decline of -6.4 mL/min/1.73 m²/yr. During the 24-week treatment period, vonafexor treatment resulted in a mean functional gain of +4.8 mL/min/1.73 m²/yr, representing an impressive shift from the natural history of disease progression. Sustained eGFR Benefit (Off-Drug): Following treatment discontinuation, kidney function benefits persisted. At Week 36 (12 weeks off vonafexor), mean eGFR remained +2.5 mL/min/1.73 m² above the extrapolated natural history trajectory, consistent with a durable effect. Durable Albuminuria Reduction: 73% of patients maintained a reduction in urine albumin-to-creatinine ratio (UACR) below their baseline levels three months after stopping treatment “Results from the ALPESTRIA-1 study demonstrate clinically meaningful improvements in eGFR and UACR, along with clear FXR target engagement at low doses. These findings confirm a differentiated mechanism of action consistent with preclinical data and position vonafexor as a promising therapeutic candidate for Alport syndrome, supporting continued clinical development,” said Prof. Bertrand Knebelmann, MD, PhD, Principal Investigator of the ALPESTRIA-1 study and Chair of the Strategic Advisory Board having reviewed the results. “The convergence of sustained eGFR improvement, durable albuminuria reduction, and positive patient-reported experience provides compelling evidence supporting vonafexor’s disease-modifying potential in Alport syndrome and beyond,” commented Pietro Scalfaro, MD, CMO of ENYO Pharma. “The Alpestria-1 results represent a pivotal moment for ENYO and are more importantly a watershed moment for patients living with Alport syndrome,” added Jacky Vonderscher, PhD, CEO of ENYO Pharma. Safety and Tolerability Vonafexor was generally well-tolerated, with a safety profile consistent with previous clinical trials involving over 400 subjects. The most common adverse event was pruritus, which was dose dependent and manageable through dose adjustments while maintaining pharmacological activity and efficacy. 2026 Strategic Milestones ENYO is entering a catalyst-rich year as it prepares for pivotal development: FDA Engagement : A Fast Track designation submission is planned for January 2026, with a Type-D-meeting response expected mid-month. Pivotal Phase 3 : an End-of-Phase 2 meeting is planned for Q2 2026, with initiation of a Phase 3 study in Alport syndrome in the second half of 2026. Pipeline Expansion : ENYO is also considering initiation of a Phase 2 proof-of-concept study of vonafexor in Autosomal Dominant Polycystic Kidney Disease (ADPKD) and of EYP651 in common renal diseases in H2 2026. ENYO Pharma management will be in San Francisco during the upcoming 44th Annual J.P. Morgan Healthcare Conference to discuss these data and the company’s 2026–2031 roadmap with potential partners and investors. About Vonafexor Vonafexor is a once-daily, oral, non-bile acid FXR agonist designed with a unique chemical scaffold that prioritizes delivery to the kidney. By regulating metabolic, inflammatory, and fibrotic pathways, Vonafexor addresses the core drivers of renal injury and extracellular matrix remodeling. About ENYO Pharma SA: ENYO is a clinical-stage biopharmaceutical company headquartered in Lyon (France) and developing proprietary drug candidates to improve quality of life and avoid end stage renal disease and dialysis for patients with rare and common kidney diseases. Since its inception ENYO collected extensive phase I/II clinical data through 9 completed clinical studies with 400+ subjects. The company's pipeline includes vonafexor and EYP651, a next-generation FXR agonist entering Phase 2 studies in 2H 2026 for common renal diseases (CKD/DKD). For more information: ENYO Pharma – Developing therapeutics for diseases with impaired kidney function

Phase 2Clinical ResultFast Track

12 Jun 2025

·www.businesswire.com

ENYO Pharma Announces Completion of Series C Financing With Vesalius Biocapital and Continued Progress of Its ALPESTRIA-1 Clinical Phase 2 Study in Alport Syndrome Patients

LYON, France--(BUSINESS WIRE)--ENYO Pharma (“ENYO”), a clinical-stage biotechnology company focused on developing FXR agonists for the treatment of severe kidney diseases, today announced the smooth continuation of its Phase 2 ALPESTRIA-1 trial in 26 Alport syndrome patients. The topline results from the trial are on track for the fourth quarter of 2025. In parallel, ENYO has finalized its Series C financing round with a €6 million investment from Vesalius Biocapital IV, bringing the total Series C raise to €32 million. The ongoing ALPESTRIA-1 study evaluates Vonafexor, a highly selective and oral FXR agonist, in patients with Alport syndrome, a rare genetic kidney disease with no approved therapy. The trial involves a 24-week ascending doses regimen followed by a 12-week off-treatment observation period. ALPESTRIA-1 was launched mid 2024 in 4 countries (US, F, SP and D) following Orphan Drug Designation from both the FDA and EMA. The new funding from Vesalius Biocapital IV extends ENYO’s cash runway through the second half of 2026 and enables the initiation of two new clinical programs: A proof-of-concept trial in patients with Chronic Kidney Disease (CKD) grade 3 and concurrent F2/F3 MASH , building on the promising renal results from the previous Phase 2 LIVIFY clinical study ; A PK/PD head-to-head comparison of Vonafexor and its analog EYP651 in healthy subjects. In addition, ENYO will continue to expand its preclinical portfolio, notably in Autosomal Dominant Polycystic Kidney Disease (ADPKD), where the Vonafexor franchise could offer a novel and disease-modifying approach. “We are pleased with the continued progress of ALPESTRIA-1 and honored to welcome Vesalius Biocapital to our investor syndicate and Dr. Jean-Christophe Renondin as new Board member,” said Dr. Jacky Vonderscher, CEO of ENYO. “This additional investment will allow us to accelerate the development of our FXR agonist pipeline in both rare and more prevalent kidney diseases. We share a common belief with Vesalius in the transformative potential of Vonafexor and EYP651 for patients suffering from inflammation- and fibrosis-driven renal conditions.” “Vesalius Biocapital is excited to support ENYO as it progresses into the next phase of clinical development for Vonafexor and its analog EYP651,” commented Dr. Jean-Christophe Renondin, Managing Partner at Vesalius Biocapital IV. “There is an immense need for new treatments in kidney conditions such as Alport Syndrome and CKD. We believe Vonafexor has the potential to help these patients and make a meaningful impact on their lives. I look forward to working with ENYO’s excellent leadership team to advance this promising therapeutic candidate.” About ENYO Pharma: ENYO is a clinical-stage biopharmaceutical company headquartered in Lyon (France) and developing proprietary drug candidates to improve quality of life and avoid end stage renal disease and dialysis/transplantation for patients with rare and common kidney diseases. Since its inception ENYO collected extensive phase I/II clinical data through nine completed clinical studies with ca. 400 subjects. ENYO is supported by a strong syndicate of global investors: OrbiMed, Morningside, AndEra, BPIFrance (InnoBio and Large Venture), Sofinnova Partners and Vesalius). For more information: ENYO Pharma About Vesalius Biocapital: Vesalius is a specialist life sciences venture capital investor, investing in companies in later stage companies in drug development, medical device diagnostic and e-health since 2007. Vesalius Biocapital IV, launched in June 2023, targets first and best-in-class European life science companies in drug development and digital health. Its investment portfolio is well balanced between drug development and non-drug development investments and committed to providing capital to science-backed innovation and ambitious entrepreneurs. The team is based in Europe to explore investment opportunities and valuation potential for the portfolio. Managing Partners include Guy Geldhof, Dr Jean-Christophe Renondin and Stéphane Verdood. https://www.vesaliusbiocapital-4.com/

Phase 2Orphan Drug

100 Deals associated with Vonafexor

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nephritis, Hereditary	Phase 2	United States	ENYO Pharma SA	01 Aug 2024
Nephritis, Hereditary	Phase 2	France	ENYO Pharma SA	01 Aug 2024
Nephritis, Hereditary	Phase 2	Spain	ENYO Pharma SA	01 Aug 2024
Hepatitis B, Chronic	Phase 2	Australia	ENYO Pharma SA	12 May 2020
Hepatitis B, Chronic	Phase 2	Hong Kong	ENYO Pharma SA	12 May 2020
Hepatitis B, Chronic	Phase 2	Poland	ENYO Pharma SA	12 May 2020
Hepatitis B, Chronic	Phase 2	South Korea	ENYO Pharma SA	12 May 2020
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	United States	ENYO Pharma SA	30 Jan 2019
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	Belgium	ENYO Pharma SA	30 Jan 2019
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	France	ENYO Pharma SA	30 Jan 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06425055 (ALPESTRIA-1, ASN2025)	Phase 2	Nephritis, Hereditary	26	Vonafexor	ifrjpyaskj(chylqewzcc) = srorypvods ovyayyxtet (jwwfzgowmb ) View more	Positive	06 Nov 2025
NCT03812029 (LIVIFY, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	120	Placebo (Placebo Part B)	jrparpvkaz(jbuybgbcuh) = rqdeneazgq kydvdnchqb (zcfptjueyx, qtjalysiks - kjoonbkvbd) View more	-	06 May 2023
				Vonafexor (Vonafexor 100 mg QD Part B)	jrparpvkaz(jbuybgbcuh) = wagtirqqpn kydvdnchqb (zcfptjueyx, qzjzvjondc - vgifwvydpp) View more
NCT04465916 (CTgov)	Phase 2	Hepatitis B, Chronic	26	Nucleotide analogue (Entecavir or Tenofovir Disoproxil)+EYP001a (Experimental Arm)	lgdhzygpoj(zhridspchy) = hubiihtjbv clxluxlqbs (gjibvsskjf, 0.0195) View more	-	12 Oct 2022
				Nucleotide analogue (Entecavir or Tenofovir Disoproxil) (Control Arm)	lgdhzygpoj(zhridspchy) = wuvqilazcm clxluxlqbs (gjibvsskjf, 0.0348) View more
NCT04365933 (EYP001-203, BusinessWire) Manual	Phase 2	Hepatitis B, Chronic	20	Entecavir+Peginterferon alfa-2a+Vonafexor	ayfqwbcacl(wsjgyqnqhu) = cwkbrszeid vverloyujs (ccnoszpuar )	Positive	30 Jul 2021
				Peginterferon alfa-2a+Vonafexor	ayfqwbcacl(wsjgyqnqhu) = fwwaugkadb vverloyujs (ccnoszpuar )

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