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Find Endocrinology Drugs in Phase II Clinical Development

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            Lead Product(s): Fluasterone

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institutes of Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement December 02, 2020

            Details:

            SteroTherapeutics will provide the study drug (non-androgenic analogue of dehydroepiandrosterone) and placebo to enable the NICHD to conduct the Phase 2 clinical trial in the treatment of the manifestations of Cushing syndrome.

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            Lead Product(s): Ibutamoren

            Therapeutic Area: Endocrinology Product Name: LUM-201

            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 November 10, 2020

            Details:

            The trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy.

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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: AzurRx BioPharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership November 10, 2020

            Details:

            Under the terms of the agreement, Asymchem will implement fermentation, verify protein expression and ultimately fine-tune the technology suitable for production of MS1819.

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            Lead Product(s): MBX-2982

            Therapeutic Area: Endocrinology Product Name: MBX-2982

            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 November 05, 2020

            Details:

            The objective of the study is to determine if GPR119 agonists have potential to prevent hypoglycemia for people living with T1D. The trial is funded by a nearly $1.2 million grant from The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley).

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: ORMD-0801

            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 October 28, 2020

            Details:

            The poster titled, “Glycemic Effects of Bedtime Oral Insulin (ORMD-0801) in Uncontrolled Type 2 Diabetes Mellitus Patients” will be presented at American Association of Pharmaceutical Scientists 2020 PharmSci 360 Conference.

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            Lead Product(s): TransCon PTH

            Therapeutic Area: Endocrinology Product Name: TransCon PTH

            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 October 23, 2020

            Details:

            TransCon PTH is a once-daily long-acting prodrug of parathyroid hormone in development for the treatment of adult HP, which is designed to replace PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of HP.

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: ORMD-0801

            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 October 16, 2020

            Details:

            Based on guidance received from the U.S FDA as part of the End-of-Phase 2 meeting process for our oral insulin candidate, ORMD-0801, Oramed has submitted to the FDA the protocols for its upcoming pivotal Phase 3 studies.

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            Lead Product(s): Eftansomatropin

            Therapeutic Area: Endocrinology Product Name: TJ101

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Genexine

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

            Details:

            The phase 3 trial is a study designed to assess the safety, efficacy and pharmacokinetics of eftansomatropin in PGHD. The primary objective is to demonstrate non-inferiority of eftansomatropin administered in subcutaneous injection, compared to the active control Norditropin®.

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            Lead Product(s): TTP399

            Therapeutic Area: Endocrinology Product Name: TTP399

            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 September 23, 2020

            Details:

            The data presented at EASD add to the growing body of evidence supporting the potential of TTP399 to meet the urgent yet still unmet need for an adjunctive therapy for patients living with T1D that improves disease management and health outcomes.