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

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            Lead Product(s): CM-101

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

            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 23, 2020

            Details:

            The clinical trial is a multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy profile of CM-101 in adult subjects with PSC.

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            Lead Product(s): HM15211

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HM15211

            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 22, 2020

            Details:

            The novel drug is under development with the company’s Lapscovery, a platform technology that prolongs the duration of action of biologics, making it possible for patients to take weekly or monthly administration.

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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): CM-101

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

            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:

            The clinical trial is a multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy profile of CM-101 in adult subjects with PSC.

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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): Tvb-2640

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40

            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 20, 2020

            Details:

            This bridging study in China demonstrated linear pharmacokinetic for ASC40 (TVB-2640) from oral, single doses of 25, 50 to 75 mg. ASC40 is safe and well-tolerated in Chinese subjects and majority of adverse events are grade1.

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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): Lanifibranor

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337

            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 06, 2020

            Details:

            Following higher than expected effects on steatosis reduction during the Phase IIb NATIVE trial in NASH, the number of patients to be recruited in the trial evaluating lanifibranor in patients with T2DM and NAFLD has been reduced to 34 (vs. 64 initially).

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            Lead Product(s): Namodenoson

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CF102

            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 30, 2020

            Details:

            Results confirm 25 mg Namodenoson as optimal dose based on MRI-PDFF analysis and liver enzymes, reduction of liver fibrosis and resolving all cases of NASH; Namodenoson continues to demonstrate a very good safety profile after drug treatment.

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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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