Endocrinology | Phase II Developments | UNITED STATES

Oramed Pharmaceuticals

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Oramed Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA

Lead Product(s): Insulin

Therapeutic Area: Endocrinology

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 19, 2020

Details:

During this meeting the FDA provided feedback on key issues relating to Drug Product manufacture and supported continuing to Phase 3 clinical development.

Oramed Pharmaceuticals

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Oramed Reports Positive Results in the Final Cohort of Its Phase 2b Oral Insulin Trial

Lead Product(s): Insulin

Therapeutic Area: Endocrinology

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 26, 2020

Details:

Primary endpoints were successfully met; results confirm significant clinical benefits of ORMD-0801 at lower dose treatment, 0.95% A1C reduction in patients treated once daily at 8mg.

AzurRx BioPharma

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AzurRx BioPharma Announces Presentation of Phase II MS1819 Data in Cystic Fibrosis at the 2020 Digestive Disease Week Conference

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

Therapeutic Area: Endocrinology

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 18, 2020

Details:

The presentation showcases the results from a Phase 2, 2x2 cross-over trial to assess the safety and efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

Rezolute

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Rezolute Initiates Phase 2b Clinical Trial of Lead Candidate RZ358

Lead Product(s): RZ358

Therapeutic Area: Endocrinology

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 10, 2020

Details:

The Company has screened the first patient and expects to make significant enrollment progress to enable attainment of mid-study results over the coming year.

Vtv Therapeutics

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vTv Therapeutics Unveils Results from Simplici-T1 Study of TTP399

Lead Product(s): TTP399

Therapeutic Area: Endocrinology

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 10, 2020

Details:

TTP399, a novel glucokinase activator, achieves primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis.

Xeris Pharmaceuticals

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Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of Its Developmental Ready-To-Use (RTU) Glucago...

Lead Product(s): Glucagon

Therapeutic Area: Endocrinology

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 06, 2020

Details:

Results show a mini dose (150 µg) of RTU glucagon prevents Exercise-Induced Hypoglycemia (EIH) during prolonged, moderate-to-high intensity aerobic exercise in a clinical research setting.

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Oramed Pharmaceuticals

Oramed Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA

Oramed Pharmaceuticals

Oramed Reports Positive Results in the Final Cohort of Its Phase 2b Oral Insulin Trial

AzurRx BioPharma

AzurRx BioPharma Announces Presentation of Phase II MS1819 Data in Cystic Fibrosis at the 2020 Digestive Disease Week Conference

Rezolute

Rezolute Initiates Phase 2b Clinical Trial of Lead Candidate RZ358

Vtv Therapeutics

vTv Therapeutics Unveils Results from Simplici-T1 Study of TTP399

Xeris Pharmaceuticals

Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of Its Developmental Ready-To-Use (RTU) Glucago...