Endocrinology | Phase II Developments

AzurRx BioPharma

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United States

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AzurRx BioPharma Closes $15.2 Million Private Placement and $6.9 Million Convertible Note Exchange

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.

Oramed Pharmaceuticals

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Oramed Reports Positive End of Phase 2 Meeting With the FDA for Oral Insulin

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.

Diamyd Medical AB

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Sweden Sweden

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All Patients Have Completed their 15-month Visits in the European Phase IIb Trial with the Diabetes Vaccine Diamyd

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.

Center Laboratories

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TAIWAN Taiwan

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CS02 Changes the Landscape of Diabetes Treatment: CenterLab Announces Positive Topline Results of Phase 2 Trial

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%.

Crinetics Pharmaceuticals

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Crinetics Pharmaceuticals Receives Orphan Drug Designation for Paltusotine for the Treatment of Acromegaly

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.

Zealand Pharma

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DENMARK Denmark

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Zealand Pharma Announces First Patient Dosed in Phase 2 Trial With Long-Acting GLP-1/Glucagon Dual Agonist in Obesity/Diabetes

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.

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.

Novo Nordisk

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DENMARK Denmark

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Investigational, Once-Weekly Insulin Icodec Showed Comparable Efficacy and Safety to Once-Daily Insulin Glargine U100 In Phase 2 Trial

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.

Dompe Farmaceutici

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ITALY Italy

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Dompé Presents Phase II Clinical Trial Results for Ladarixin in New-Onset Type 1 Diabetes

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).

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.

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Find Endocrinology Drugs in Phase II Clinical Development

Phase II

Product Type

Companies

AzurRx BioPharma

AzurRx BioPharma Closes $15.2 Million Private Placement and $6.9 Million Convertible Note Exchange

Oramed Pharmaceuticals

Oramed Reports Positive End of Phase 2 Meeting With the FDA for Oral Insulin

Diamyd Medical AB

All Patients Have Completed their 15-month Visits in the European Phase IIb Trial with the Diabetes Vaccine Diamyd

Center Laboratories

CS02 Changes the Landscape of Diabetes Treatment: CenterLab Announces Positive Topline Results of Phase 2 Trial

Crinetics Pharmaceuticals

Crinetics Pharmaceuticals Receives Orphan Drug Designation for Paltusotine for the Treatment of Acromegaly

Zealand Pharma

Zealand Pharma Announces First Patient Dosed in Phase 2 Trial With Long-Acting GLP-1/Glucagon Dual Agonist in Obesity/Diabetes

Xeris Pharmaceuticals

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

Novo Nordisk

Investigational, Once-Weekly Insulin Icodec Showed Comparable Efficacy and Safety to Once-Daily Insulin Glargine U100 In Phase 2 Trial

Dompe Farmaceutici

Dompé Presents Phase II Clinical Trial Results for Ladarixin in New-Onset Type 1 Diabetes

Xeris Pharmaceuticals

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