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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)

            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 May 15, 2020

            Details:

            Clinical data for lead candidate TLANDO™ will be presented at the American Urological Association Virtual Conference. TLANDO is an oral testosterone replacement therapy product candidate for adult males with hypogonadism.

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            Lead Product(s): LPCN 1144

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 May 13, 2020

            Details:

            The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis.

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            Lead Product(s): EDP-305

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 May 07, 2020

            Details:

            The INTREPID study was a 12-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with PBC.

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            Lead Product(s): Tvb-2640

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 March 31, 2020

            Details:

            TVB-2640 versus placebo demonstrated clinically significant reduction in liver fat by MRI-PDFF in NASH: A phase 2 randomized controlled trial (FASCINATE-1).

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            Lead Product(s): AKR-001

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 March 31, 2020

            Details:

            Three AKR-001 dose groups in the BALANCED study met the primary endpoint of absolute change from baseline in liver fat as measured by magnetic resonance imaging.

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            Lead Product(s): EDP-305

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 March 26, 2020

            Details:

            Enanta has paused recruitment and dosing in ARGON-2 Phase 2b NASH study and pausing further recruitment in Part 2 of Phase 1a/1b study of EDP-514 in nuc-suppressed hepatitis B (HBV) patients.

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            Lead Product(s): Elobixibat

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 March 10, 2020

            Details:

            Trial enrolled 47 patients, and is designed to assess the safety and efficacy of a once-daily 5mg dose of elobixibat over 16 weeks in adult patients across 10 U.S. sites with biopsy-confirmed NASH.

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            Lead Product(s): Aldafermin

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 February 24, 2020

            Details:

            Clinically meaningful response rates of 38% of patients treated with aldafermin having liver fibrosis improvement of ?1 stage and 24% of patients achieving resolution of NASH at 24 weeks

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            Lead Product(s): Tipelukast

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 February 17, 2020

            Details:

            The allowed claims cover MN-001 and MN-002 for use in the treatment of a patient with advanced NASH.

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            Lead Product(s): AKR-001

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 January 13, 2020

            Details:

            The ongoing Phase 2a BALANCED study of AKR-001 is being expanded to include an additional cohort of subjects with NASH who have compensated cirrhosis (F4), Child-Pugh Class A

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