Endocrinology | Phase II Developments | UNITED STATES

Xeris Pharmaceuticals

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Xeris Pharmaceuticals Announces Positive Topline Results from the Phase 2 Comparative Study of XP-3924 in Adults with Type 1 DM

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.

Xeris Pharmaceuticals

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Xeris Pharmaceuticals Announces Results From the Outpatient Stage of a Phase 2 Study of Its Developmental Gvoke Micro™ Glucagon

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.

Diasome Pharmaceuticals

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Diasome Reports Substantial Reductions in Level 2 Hypoglycemia Events in its Phase 2b OPTI-1 Study of Hepatocyte Directed Vesicle Technology...

Lead Product(s): Insulin

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:

Diasome presented new positive data from its Phase 2b OPTI-1 clinical trial in people with type 1 diabetes (T1D) at the American Diabetes Association’s 80th Annual Scientific Sessions.

Vtv Therapeutics

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vTv Therapeutics Presents Data on Simplici-T1 Study Supporting the Role of TTP399 as an Oral Adjunctive Therapy for Type 1 Diabetes

Lead Product(s): TTP399

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 13, 2020

Details:

Treatment with TTP399 resulted in significant improvements in HbA1c with reduction in insulin, without increasing risk of hypoglycemia or diabetic ketoacidosis (DKA).

Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals Confirms Completion for Half of the Enrolled Patients in the Ongoing Phase 2 ACROBAT Edge Trial for Paltusotine

Lead Product(s): Paltusotine

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 11, 2020

Details:

28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands (SRLs).

Neurocrine Biosciences

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Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020

Lead Product(s): Crinecerfont

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 08, 2020

Details:

Phase II clinical study of crinecerfont (NBI-74788), demonstrated meaningful reductions in all three key disease hormone markers in adult patients with classic congenital adrenal hyperplasia (CAH), a genetic disorder affecting the adrenal glands.

Vtv Therapeutics

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vTv Therapeutics to Present Full Clinical Study Results from the Positive Phase 2 Simplici-T1 Study of TTP399

Lead Product(s): TTP399

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 May 27, 2020

Details:

Two late-breaking abstracts reinforcing the potential of TTP399 as an oral adjunctive therapy in type 1 diabetes will be presented virtually at the American Diabetes Association’s 80th Scientific Sessions.

Xeris Pharmaceuticals

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Xeris Shares Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon

Lead Product(s): Glucagon

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 May 22, 2020

Details:

Rebound hypoglycemia observed in the placebo arm with oral glucose tablet use; No rebound hypoglycemia observed in the RTU glucagon treatment arm.

Oramed Pharmaceuticals

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Oramed Pharmaceuticals to Present at the 80th American Diabetes Association Scientific Session, to be Held Virtually This Year in June

Lead Product(s): Insulin

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 May 06, 2020

Details:

The presentations will focus on Oramed's oral insulin candidate, ORMD-0801 and its impact on type-2 diabetes mellitus, as well as its impact on fatty liver in nonalcoholic steatohepatitis (NASH).

Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock

Lead Product(s): Paltusotine

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: SVB Leerink

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering April 14, 2020

Details:

Crinetics intends to use the net proceeds to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

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Xeris Pharmaceuticals

Xeris Pharmaceuticals Announces Positive Topline Results from the Phase 2 Comparative Study of XP-3924 in Adults with Type 1 DM

Xeris Pharmaceuticals

Xeris Pharmaceuticals Announces Results From the Outpatient Stage of a Phase 2 Study of Its Developmental Gvoke Micro™ Glucagon

Diasome Pharmaceuticals

Diasome Reports Substantial Reductions in Level 2 Hypoglycemia Events in its Phase 2b OPTI-1 Study of Hepatocyte Directed Vesicle Technology...

Vtv Therapeutics

vTv Therapeutics Presents Data on Simplici-T1 Study Supporting the Role of TTP399 as an Oral Adjunctive Therapy for Type 1 Diabetes

Crinetics Pharmaceuticals

Crinetics Pharmaceuticals Confirms Completion for Half of the Enrolled Patients in the Ongoing Phase 2 ACROBAT Edge Trial for Paltusotine

Neurocrine Biosciences

Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia at ENDO Online 2020

Vtv Therapeutics

vTv Therapeutics to Present Full Clinical Study Results from the Positive Phase 2 Simplici-T1 Study of TTP399

Xeris Pharmaceuticals

Xeris Shares Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon

Oramed Pharmaceuticals

Oramed Pharmaceuticals to Present at the 80th American Diabetes Association Scientific Session, to be Held Virtually This Year in June

Crinetics Pharmaceuticals

Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock