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Wednesday, July 14, 2021 7:37:37 AM
Lots of announcements from companies today about presentations at the upcoming EASL conference. Hepion will almost certainly be presenting something there, too. If so, we'll see whether they announce it tomorrow morning, or do like they did with the EASL presentation last August, with the PR on the same day as the presentation of CRV431 P1 results.
HEPA CRV431 is the most optimal antifibrotic drug in the clinic. The wide array of applications this drug can be used for can make HEPA 50- 100 Billion dollar company in the next 5 year years. No FDA approved drugs for NASH
The International Liver Congress 2021 will begin on Wednesday June 23 and ends on Saturday, June 26 2021 https://easl.eu/event/the-international-liver-congress-2021/
NASH is 35 Billion dollar market that will near 100 Billion next 5-10 years.
Hepion - Page S321 https://easl.eu/wp-content/uploads/2021/06/EASL_2021_-Version-1_new.pdf
Background and aims:The canonical experimental models (i.e. cellculture and rodents) for the study of Alcohol-related Liver Diseases(ALD) present limitations which impede the advancement of noveltherapies, particularly the difficulty in recapitulating the spectrum of pathological manifestations associated with the development/pro-gression of ALD in humans including steatosis, inflammation, hepatotoxicity, fibrosis and cirrhosis. The need to overcome this barrier to drug development underpins the current study. We describe the development of an immunocompetent ex-vivo humanmodel of ALD based on the culture of Precision Cut Liver Slices (PCLS)and their direct application for the assessment of the the Therapeutic effects of the cyclophilin inhibitor, CRV431.Method:Tumour-free liver specimens (‘healthy’or cirrhotic) we recollected from patients (n = 22) undergoing resection of livermetastasis. PCLS were made from the resected tissue, cultured forup to 5 days, and exposed to hepatotoxic insults: ethanol 50–250 mM, oleic/linoleic acids 0.1 mM, and LPS 10 µg/ml. The thera-peutic effects of 5 µM CRV431 were studied for the duration of theculture. Viability and cell death were evaluated by histology,cytokeratin 18 release, and ATP content. Steatosis was evaluated byOil-Red-O staining. Fibrosis was measured by gene expression,secretion and histology. Inflammatory cytokines were quantified byluminex. Mitochondrial fitness was evaluated by functional andmorphological assays.Results:The exposure of PCLS to ethanol for increasing time periods(up to 5 days) could mimic the clinical features of ALD. Early ethanolexposure was characterised by low overall cell death but increasedmitochondrial alterations. The addition of fatty acids and an acuteinflammatory hit (LPS) promoted steatohepatitis, inflammatorycytokine production and fibrosis. The cirrhotic PCLS were used toinvestigate tissue architecture and fibrotic processes in the context oflate stage chronic disease. PCLS treated with CRV431 maintainedgood viability, mitochondrial function, and low apoptosis over theculture duration. CRV431 also tempered inflammation in thepresence of LPS and induced a dramatic decrease in gene expressionand deposition of Collagen and Timp-1.Conclusion:In summary, we have developed a versatile immuno-competent platform which can reliably recapitulate the clinicalfeatures of ALD and have shown that it can be effectivelyemployed toassess the efficacy of novel immunomodulatory and anti-fibrotictherapeutic agents.PO-2331Past hospital contacts due to alcohol do not predict fibrosis stagein alcohol-related liver disease. A study of alcohol diagnoses andmorbidity in 18 years leading up to biopsy-proven liver fibrosis in462 patientsDitlev Rasmussen1, Maria Kjærgaard1, Katrine Prier Lindvig1,Mads Israelsen1, Kathrine Thorhauge1, Nikkolaj Christian Torp1,Stine Johansen1, Sönke Detlefsen2, Aleksander Krag1, Maja Thiele1.1Odense University Hospital, Departnemt of Gastroenterology andHepatology;2Odense University Hospital, Department of Pathology,DenmarkEmail: ditlev.nytoft.rasmussen@regionh.dk.Background and aims:Decompensated alcohol-related liver diseaseis preceded by several years of excessive drinking. Hospital contactsforalcohol problems are potential opportunities forearly detection ofcirrhosis. We aimed to investigate whether patients with biopsy-proven severe fibrosis and cirrhosis had more past hospital contactsdue to alcohol than alcohol-overusing patients with significant or minimal fibrosis.
Phase 2A data on CRV431 225mg between next week and the end of June. Last year they announced the day before the conference they where presenting. And as well as inclusion into Russell index!!
Phase CRV431 2A preliminary conclusions:
1.Reduction in transaminases at 28 days signals early efficacy in F2/F3 NASH subjects.
2.CRV431 in NASH Phase 2a Preliminary ConclusionsReduction in transaminases at 28 days signals early efficacy in F2/F3 NASH subjectsCRV431 concentration predicts reductions in serum alanine transaminase.
3.Trial Simulations suggest greater expected efficacy at 150 mg and 225 mg dose levels.
4.Bioinformatics with AI-POWR?reveal significant interactions with collagen regulating genes.
5.Confirmation of these effects will be fully evaluated using the 225 mg cohort and the final genomic, lipidomic, and biomarker data for a full simulation of the Phase 2b Trial.
AI-POWR™ Confers Strategic Advantages from Clinical Trials to Commercialization: A.Novel drug target selection B.Biomarker selection and validation C.Patient selection (-responder analysis) De-risk clinical trials D.Improve drug development efficiency with cost savings
HEPA molecule CRV431 for NASH is safer than MDGL & AKRO & HEPA Efficacy looks next level. These 2 companies MDGL & AKRO are both Billion dollar plus companies look for HEPA market cap to grow exponentially.
Key take away: In just 28 days at the low dose, HEPA CRV431 results were as good as what Madrigal's P3 lead NASH drug took 12 weeks to accomplish.
June 2021 Hepa Biz Presentation https://hepionpharma.com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL.pdf
HEPA AI-POWR https://hepionpharma.com/ai-powr/
HEPA Tackling Chronic Liver Disease - CRV431 Mechanism of Action
HEPA GLOBAL NASH CONFERENCE PRESENTATION: https://12ewye24eigk3g5kwa2dxjzm-wpengine.netdna-ssl.com/wp-content/uploads/2021/04/4thGlobal_NASH_Congress_Draft_20Apr2021_FINAL-1.pdf
HEPA website https://hepionpharma.com
Nash Phase 2 & 3 Trials by companies in the space: AKRO Akero Therapeutics 1.1 Billion Marketcap 240 Million in cash MDGL Madrigal Pharmaceutical 1.7 Billion Marketcap 300 Million in cash HEPA Hepion Pharmaceuticals 160 Million market cap 120 million in cash
$HEPA
Recent HEPA News
- Pharma Two B and Hepion Pharmaceuticals, Inc. Announce Filing of Registration Statement on Form F-4 Related to Proposed Merger • GlobeNewswire Inc. • 09/04/2024 01:25:00 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/07/2024 01:08:47 PM
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- Pharma Two B Announces Plans to Go Public via Merger with Hepion Pharmaceuticals, Inc. and Concurrent $11.5 Million Private Placement • GlobeNewswire Inc. • 07/22/2024 12:00:00 PM
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- Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial • GlobeNewswire Inc. • 04/19/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 02:02:26 PM
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- Hepion Pharmaceuticals Announces Major Reductions in Liver Stiffness with Rencofilstat Treatment in 17-week Phase 2 Study of Advanced (F3) MASH Liver Disease • GlobeNewswire Inc. • 11/13/2023 09:05:00 PM
- Hepion Pharmaceuticals Schedules Conference Call to Review Additional Efficacy Data from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat • GlobeNewswire Inc. • 11/10/2023 01:50:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/09/2023 05:15:08 AM
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