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Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): Testosterone Undecanoate

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: LPCN 1144

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 03, 2020

            Details:

            Treatment with LPCN 1144 (oral T prodrug) in hypogonadal males with NAFLD resolved NAFLD in approximately half of the affected patients without any safety signals.

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            Lead Product(s): TERN-101

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TERN-101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 30, 2020

            Details:

            Results from single and multiple ascending dose cohorts demonstrate TERN-201 is generally safe and well tolerated and results in potent and sustained inhibition of plasma SSAO activity.

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            Lead Product(s): TERN-101

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TERN-101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 22, 2020

            Details:

            Trial is evaluating the safety and efficacy of farnesoid X receptor (FXR) agonist TERN-101 in NASH patients.

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            Lead Product(s): Efruxifermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AKR-001

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 21, 2020

            Details:

            Data in the journal Cell Reports Medicine from the Phase 1 clinical trial of efruxifermin (EFX, formerly AKR-001), a fibroblast growth factor 21 analog, demonstrating its potential to modulate biomarkers associated with metabolic diseases, including NASH.

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            Lead Product(s): HepaStem

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HepaStem

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Aceso Life Science Holding

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 17, 2020

            Details:

            The Joint Venture Company is vested with the exclusive right to develop, register, distribute and commercialize Promethera®'s therapeutic products (cell therapies and antibodies developed by Promethera® Group) in China and Southeast Asia.

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            Lead Product(s): Efruxifermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AKR-001

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            Of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.

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            Lead Product(s): Efruxifermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AKR-001

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            The company plans to discuss new efficacy and safety data, including biopsy results, from its Phase 2a BALANCED study of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) in a post-market press release and webcast.

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            Lead Product(s): TERN-101

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TERN-101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 18, 2020

            Details:

            Terns Pharmaceuticals has screened the first patient for the LIFT study, a Phase 2a clinical trial of TERN-101, a liver-selective farnesoid X receptor (FXR) agonist, the company's lead development candidate for the treatment of non-alcoholic steatohepatitis (NASH).

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            Lead Product(s): Tvb-2640

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TVB-2640

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2020

            Details:

            The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis.

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            Lead Product(s): AKR-001

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: AKR-001

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2020

            Details:

            First subject has been dosed in Cohort C, the previously-announced expansion of its Phase 2a BALANCED trial, which will enroll 30 subjects who have NASH with compensated cirrhosis (F4), Child-Pugh Class A.

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