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Details:
CRV431 (rencofilstat) is a Cyclophilin A inhibitor has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of Idiopathic Pulmonary Fibrosis, and has demonstrated antiviral activities towards HBV, HCV, and HDV.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2023
Details:
Hepion intends to use the net proceeds from the offering for clinical development of CRV431 (rencofilstat), an oral drug candidate for nonalcoholic steatohepatitis (NASH) and viral hepatitis-induced liver disease.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 29, 2023
Details:
CRV431 (rencofilstat) is a Cyclophilin A inhibitor has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of Idiopathic Pulmonary Fibrosis, and has demonstrated antiviral activities towards HBV, HCV, and HDV.
Lead Product(s): Rencofilstat
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: CRV431
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2023
Details:
CRV431 (rencofilstat) is a Cyclophilin A inhibitor has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2023
Details:
CRV431 (rencofilstat) is a Cyclophilin A inhibitor has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
Rencofilstat specifically binds cyclophilin isomerase enzymes and inhibits cyclophilin function. Rencofilstat is being examined as a potential therapeutic for multiple myeloma.
Lead Product(s): Rencofilstat
Therapeutic Area: Oncology Product Name: CRV431
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2023
Details:
CRV431 (rencofilstat) specifically binds cyclophilin isomerase enzymes and inhibits cyclophilin function, resulting in reduced inflammatory damage to the liver.. Rencofilstat has demonstrated efficacy in two distinct animal models of NASH and HBV replication.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2023
Details:
CRV431 (rencofilstat) is a potent inhibitor of cyclophilins and is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alberta Innovation Employment Grant
Deal Size: $0.3 million Upfront Cash: Undisclosed
Deal Type: Funding January 09, 2023
Details:
CRV431 (Rencofilstat), has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
CRV431 (rencofilstat), a potent inhibitor of cyclophilins, has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
Company’s lead drug candidate, CRV431 (rencofilstat), is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Reductions in alanine transaminase, a biomarker of liver damage, were greater in the rencofilstat (CRV431) arms versus the placebo groups and was statistically different in the 225-mg cohort compared to the placebo cohort (−16.3 ± 25.5% versus −0.7 ± 13.4%, respectively).
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Subjects will be randomized to receive a once daily, oral dose of 75, 150, or 225 mg CRV431 (rencofilstat) soft gelatin capsules (20 subjects in each dosing cohort) over a period of four months.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HepQuant
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
In addition to using AI-POWR™ to drive its ongoing NASH clinical development, Hepion intends to use the platform to identify additional potential indications for rencofilstat (CRV431) to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
Rencofilstat (CRV431), has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Lead Product(s): Rencofilstat
Therapeutic Area: Oncology Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2022
Details:
CRV431 (rencofilstat) has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
CRV431 (Rencofilstat), has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
Results of a nonclinical research study show that its clinical phase drug candidate, CRV431 (rencofilstat), synergistically decreased liver tumor growth and extended mouse survival when combined with an anti-PD1 antibody, an immune checkpoint inhibitor.
Lead Product(s): Rencofilstat,Undisclosed
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2022
Details:
CRV431 is an oral soft gel capsule, administered once daily has recieved fast track designation for the treatment of non-alcoholic steatohepatitis. It has been well-tolerated and has shown signals of efficacy in NASH in this early Phase 2 study.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
CRV431 targets several isoforms of cyclophilins which comprise a family of enzymes involved in processes including collagen production, inflammation, cell injury, cell death, and protein folding. CRV431 is a potent inhibitor of cyclophilins used in treatment of NASH.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
The trial was designed to investigate once daily oral administration of CRV431 at doses of 75 mg and 225 mg administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
Hepion’s clinical drug candidate, CRV431 administered once daily orally, seeks to target fibrosis, and the company’s latest in vivo animal study further lends validity to this mechanism.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
Hepion will showcase positive top line data from the low dose cohort in the Company's Phase 2a ‘AMBITION' clinical trial of CRV431 and the planned use of its AI-POWR™ platform in conjunction with PK-PD studies to enrich its Phase 2b study design and optimize it for outcomes.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
DSMB Recommended the AMBITION Study Continue with Final Dosing Cohort. Two interim analyses were performed by a DSMB to evaluate the safety and tolerability of the 75 mg CRV431 dose cohort in NASH patients.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
Details:
The open-label Phase 2a ‘AMBITION' study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients, once daily for 28 days.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
The poster presentation will review positive findings from an expanded study where CRV431, prevented experimentally induced liver fibrosis to a greater extent than four other leading NASH drug candidates in a human precision cut liver slices experimental model.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
CRV431 treatment was found to inhibit production of infectious virus in Caco-2 cells with almost five-times greater potency than the positive control compound in this study.
Lead Product(s): Rencofilstat
Therapeutic Area: Infections and Infectious Diseases Product Name: CRV431
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
The article reviews a study, conducted by Dr. Philippe Gallay's research group at The Scripps Research Institute, investigating the ability of CRV431 and NV556, two structurally different cyclophilin inhibitors, to inhibit hepatitis C virus ("HCV") replication in vivo.
Lead Product(s): Rencofilstat
Therapeutic Area: Infections and Infectious Diseases Product Name: CRV431
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2020
Details:
CRV431 was administered to the first NASH patient. Hepion previously announced that CRV431 successfully progressed through a phase 1 program, where the safety, tolerability and pharmacokinetics of CRV431 were evaluated in healthy subjects.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
CRV431 demonstrated strong anti-inflammatory actions in a non-viral, acute lung injury model and on some measures outperformed dexamethasone, a recently recommended treatment for COVID-19.
Lead Product(s): Rencofilstat
Therapeutic Area: Infections and Infectious Diseases Product Name: CRV431
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
Mice that underwent left ureter surgical ligation were orally administered either vehicle or CRV431 at a dose of 50 mg/kg/day for two weeks (n=8 mice/group).
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CRV431
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2020
Details:
Hepion Pharmaceuticals has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2020
Details:
The goal of the study was to determine if the anti-fibrotic activity of CRV431, which has been previously observed in many experimental models of liver disease.
Lead Product(s): Rencofilstat
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 12, 2020
Details:
In vitro studies showed that CRV431 can decrease production of the extracellular matrix molecules, collagen and fibronectin, from fibroblastic cells derived from five different organs.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2020
Details:
The open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
The presentation will provide further data from four nonclinical studies demonstrating that CRV431 decreases liver fibrosis in animal and human tissue experimental models.
Lead Product(s): Rencofilstat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2020
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