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Find Endocrinology Drugs in Phase II Clinical Development

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: MS1819

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $22.1 million Upfront Cash: Undisclosed

            Deal Type: Private Placement July 20, 2020

            Details:

            Private placement will be used to advance two Phase 2 clinical trials of MS1819 in patients with cystic fibrosis.

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: ORMD-0801

            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 15, 2020

            Details:

            The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently.

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            Lead Product(s): GAD-alum

            Therapeutic Area: Endocrinology Product Name: Diamyd

            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 13, 2020

            Details:

            Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd is expected to present Topline results at the end of September. All patients in the trial where Diamyd® is given directly into the lymph node have completed their 15-month visits according to plan.

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            Lead Product(s): CS02,Metformin

            Therapeutic Area: Endocrinology Product Name: CS02

            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 10, 2020

            Details:

            The topline results of a phase 2 clinical trial of CS02 showed significantly decreases of glycated hemoglobin (HbA1c) in treated patients as compared to placebo group by 0.45%.

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            Lead Product(s): Paltusotine

            Therapeutic Area: Endocrinology Product Name: CRN00808

            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 08, 2020

            Details:

            The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data that has been observed so far in the Phase 2 ACROBAT Edge clinical trial.

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            Lead Product(s): BI 456906

            Therapeutic Area: Endocrinology Product Name: BI 456906

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 24, 2020

            Details:

            The long-acting GLP-1/glucagon dual-agonist was concluded to have a favorable safety, tolerability and weight loss profile in Phase 1 clinical testing and it is part of Boehringer Ingelheim’s portfolio in the obesity, NASH and diabetes disease areas.

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            Lead Product(s): Pramlintide,Insulin

            Therapeutic Area: Endocrinology Product Name: Xerisol

            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 18, 2020

            Details:

            XP-3924 resulted in 62% reduction of hyperglycemia after a glucose challenge. XP-3924 showed promising glucose control when compared to both Humulin R and co-administered injections of Humulin R & Symlin and it showed improved glucose control when compared to Humulin R alone.

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            Lead Product(s): Insulin icodec

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            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 15, 2020

            Details:

            This 26-week, randomised, double-blind, double-dummy, treat-to-target phase 2 clinical trial involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin with or without a DPP-4i.

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            Lead Product(s): Ladarixin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            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 15, 2020

            Details:

            Results from Phase 2 trial demonstrate that ladarixin, a novel small molecule that inhibits the biological activity of IL-8, has potential activity in the preservation of β-cell function in new-onset type 1 diabetes (T1D).

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            Lead Product(s): Glucagon

            Therapeutic Area: Endocrinology Product Name: Gvoke RTU Micro

            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 15, 2020

            Details:

            Xeris Pharmaceuticals announced positive topline results of a Phase 2 study of its developmental Gvoke RTU Micro™ for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus who use insulin pumps.

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