Endocrinology | Phase I Developments

ProtoKinetix

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United States

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CAMBODIA PHAR-MED 2020

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Amendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials by the University of Alberta Submitted to Health Canada

Lead Product(s): Antiaging Glycopeptide

Therapeutic Area: Endocrinology Product Name: PKX-001

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2020

Details:

Upon approval from Health Canada and upon final approval by the University of Alberta ethics committee, the Company will be immediately delivering over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial.

ImmunoMolecular Therapeutics

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IM Therapeutics Announces First Patient Dosed in Ph1 Study IMT-002

Lead Product(s): IMT-002

Therapeutic Area: Endocrinology Product Name: IMT-002

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2020

Details:

The trial is designed as a single ascending dose (SAD) Phase 1a study of healthy subjects to demonstrate drug safety and tolerability.

Arecor Limited

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United Kingdom

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Arecor announces oral presentation of the first phase I clinical trial of AT247, a novel ultra rapid acting formulation of insulin

Lead Product(s): Insulin

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

The presesntation will highlight data from company's Phase I study investigating the PD, PK and safety of AT247 in comparison with NovoRapid® and Fiasp.

Hua Medicine

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CHINA China

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CAMBODIA PHAR-MED 2020

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Hua Medicine Announces Positive Results of the Combination Study of Dorzagliatin with Empagliflozin (a SGLT-2 inhibitor)

Lead Product(s): Dorzagliatin,Empagliflozin

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2020

Details:

The PK results showed no impact of dorzagliatin and empagliflozin on respective PK properties under co-administration, supporting the us of this combination in the clinical setting.

Napo Pharmaceuticals

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Jaguar Health Enters Deal with Atlas Sciences to Develop NP-500, a Jaguar Non-Core Plant-based Type II Diabetes Drug Candidate

Lead Product(s): NP-500

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Atlas Sciences

Deal Size: $1.5 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement April 16, 2020

Details:

Under the the license, Jaguar has to initiate Phase 2 study of NP-500 under an investigational new drug application with the U.S. FDA or an IND-equivalent dossier within six months of April 15, 2020.

ProtoKinetix

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ProtoKinetix Ready to Ship AAGP® to the University of Alberta for the Continuation of Phase 1 Human Trials

Lead Product(s): Antiaging Glycopeptide

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 24, 2020

Details:

The PKX-001 study will treat islet cells prior to transplantation into human test subjects. The clinical trials primary objective is the establishment of patient safety.

Auris Medical Holding

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Switzerland

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Auris Medical Provides Update on Ongoing Clinical Trials with Intranasal Betahistine

Lead Product(s): Betahistine

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 05, 2020

Details:

Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020.

PureTech Health

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United States

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PureTech Announces First Participant Trial of Wholly-Owned Lymphedema LYT-100

Lead Product(s): Pirfenidone

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 03, 2020

Details:

Multiple ascending dose and food effect study will be a follow-up to a previously conducted single ascending dose clinical trial of LYT-100.

Rani Therapeutics

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Rani Therapeutics Announces Positive Phase I Study Results of Oral Octreotide using RaniPill™

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2020

Details:

The Phase I study successfully achieved both its primary and secondary endpoints, demonstrating the safety and tolerability of Octreotide-RP.

ProtoKinetix

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ProtoKinetix Takes Delivery of GMP AAGP® PKX-001 Dedicated for Phase 1 Trial

Lead Product(s): PKX-001

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 24, 2020

Details:

GMP AAGP® PKX-001 will be sent to the University of Alberta for use in the continuation of the Phase-1 first-in-human clinical trials of PKX-001 for the treatment of Type-1 diabetes.

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Find Endocrinology Drugs in Phase I Clinical Development

Phase I

Product Type

Companies

ProtoKinetix

Amendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials by the University of Alberta Submitted to Health Canada

ImmunoMolecular Therapeutics

IM Therapeutics Announces First Patient Dosed in Ph1 Study IMT-002

Arecor Limited

Arecor announces oral presentation of the first phase I clinical trial of AT247, a novel ultra rapid acting formulation of insulin

Hua Medicine

Hua Medicine Announces Positive Results of the Combination Study of Dorzagliatin with Empagliflozin (a SGLT-2 inhibitor)

Napo Pharmaceuticals

Jaguar Health Enters Deal with Atlas Sciences to Develop NP-500, a Jaguar Non-Core Plant-based Type II Diabetes Drug Candidate

ProtoKinetix

ProtoKinetix Ready to Ship AAGP® to the University of Alberta for the Continuation of Phase 1 Human Trials

Auris Medical Holding

Auris Medical Provides Update on Ongoing Clinical Trials with Intranasal Betahistine

PureTech Health

PureTech Announces First Participant Trial of Wholly-Owned Lymphedema LYT-100

Rani Therapeutics

Rani Therapeutics Announces Positive Phase I Study Results of Oral Octreotide using RaniPill™

ProtoKinetix

ProtoKinetix Takes Delivery of GMP AAGP® PKX-001 Dedicated for Phase 1 Trial