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Thursday, 06/24/2021 6:06:41 AM

Thursday, June 24, 2021 6:06:41 AM

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Page S321
https://easl.eu/wp-content/uploads/2021/06/EASL_2021_-Version-1_new.pdf

Poster Presentation:

Human Precision Cut Liver Slices as a model of Alcohol-related Liver Disease: recapitulating disease progression in a dish.


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 therapeutic effects of the cyclophilin inhibitor, CRV431( Journal of Hepatolog 2021).


Conclusion:In summary, we have developed a versatile immuno-competent platform which can reliably recapitulate the clinical features of ALD and have shown that it can be effectively employed to assess the efficacy of novel immunomodulatory and anti-fibrotic therapeutic agents




"Nearly 45% of all deaths in the developed world are attributed to some type of chronic fibroproliferative disease. Therefore the demand for antifibrotic drugs that are both SAFE & EFFECTIVE is likely to be enormous."
-NIH

NASH 35 Billion dollar market today nearing 100 Billion in the next 7 years. NO approved NASH drugs to date.

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. HEPA has the safest NASH molecule in the clinic today by far & its pill versus vaccines by its peers is showing optimal efficacy on small doses of 75mg most anti fibrotic drug in the clinic today. Most importantly its very very safe that's what the FDA is looking for with no FDA approved drugs for NASH



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.




HEPA Tackling Chronic Liver Disease - CRV431 Mechanism of Action.



HEPA With a NASH & the dozen other possible applications HEPA is looking at this can be trading 100x from currents levels.

Former Novo Nordisk Executive, Dr. Todd M. Hobbs, Joins Hepion Pharmaceuticals as Chief Medical Officer
https://www.biospace.com/article/releases/former-novo-nordisk-executive-dr-todd-m-hobbs-joins-hepion-pharmaceuticals-as-chief-medical-officer/

Hobbs didn't leave 190 Billion dollar company as one of their highest level execs to become CMO for tiny HEPA unless its for a big reason.


HEPA 2 upgrades to $4.50 and $14.00


HEPA June 2021 HEPA Biz Presentation.
https://hepionpharma.com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL.pdf



Nash Companies in Phase 2 & 3 Trials by companies in the Space:

AKRO Akero Therapeutics 1.2 Billion Marketcap 240 Million in cash.
MDGL Madrigal Pharmaceutical 1.7 Billion Marketcap 300 Million in cash.

HEPA Hepion Pharmaceuticals 167 Million market cap 120 million in cash.

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