Pulmonary/Respiratory Diseases | Phase I Developments

aTyr Pharma

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aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Proceeds to Phase 1 Trial of ATYR1923 in Japan

Lead Product(s): ATYR1923

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: KRP-R120

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: KYORIN PHARMACEUTICAL CO LTD

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2020

Details:

Kyorin Holdings has initiated clinical development in Japan for aTyr’s lead therapeutic candidate ATYR1923 (known as KRP-R120 in Japan) following the Pharmaceutical and Medical Devices Agency (PMDA) review of its Clinical Trial Notification (CTN) submission.

Renovion

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Renovion Announces Completion of $8.1 Million Financing Round Enabling Clinical Programs in Chronic Inflammatory Lung Diseases

Lead Product(s): ARINA-1

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ARINA-1

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: White Rock Capital Management

Deal Size: $8.1 million Upfront Cash: Undisclosed

Deal Type: Series A Financing June 18, 2020

Details:

Funds to be used for the development and clinical programs associated with Renovion's lead therapeutic candidate ARINA-1. ARINA-1 is a nebulized therapy developed to improve mucus clearance and decrease inflammation in patients diagnosed with chronic lung disease.

Imperial College London

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Trevena Announces Collaboration with Imperial College London to Evaluate TRV027 in COVID-19 Patients

Lead Product(s): TRV027

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Trevena

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 02, 2020

Details:

Collaboration to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients.

Aqualung Therapeutics

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Aqualung Therapeutics Gets $2.3 M NIH Fast-Track Award To Develop Novel Therapeutic Antibody For Patients With Radiation-Induced Lung Injury

Lead Product(s): ALT-100

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: National Institute of Health

Deal Size: $2.3 million Upfront Cash: Undisclosed

Deal Type: Funding June 02, 2020

Details:

The funding is based on the company's progress in completion of the initial Fastrack Phase I studies of its novel immune-based anti-inflammatory therapeutic antibody for critically ill patients with acute lung injury.

Cellenkos

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Cellenkos Gets FDA Clearance to Initiate Phase 1 Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells for COVID-19 Associated ARDS

Lead Product(s): Cord Blood-Derived T-Regulatory Cells

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

Details:

US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS).

NantKwest

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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients

Lead Product(s): BM-Allo.MSC

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

Details:

Preliminary data from NantKwest collaborators suggests mesenchymal stem cell treatments may benefit COVID-19 patients with acute respiratory distress syndrome and cytokine storm.

Genkyotex

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Genkyotex Receives Approval From the French Medicines Agency (ANSM) to Initiate a Phase 1 Clinical Study With High-dose Setanaxib

Lead Product(s): Setanaxib

Therapeutic Area: Pulmonary/Respiratory Diseases 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 May 13, 2020

Details:

This Phase 1 study will evaluate setanaxib at doses up to 1600 mg/day in up to 54 subjects. Genkyotex is currently discussing the registration strategy for setanaxib in PBC with FDA and EMA.

Roivant Sciences

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Altasciences Completes Phase I Study on Gimsilumab for ARDS in COVID-19

Lead Product(s): Gimsilumab

Therapeutic Area: Pulmonary/Respiratory Diseases 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 27, 2020

Details:

Roivant Sciences and Altasciences are workig together for the development of gimsilumab as a potential treatment for SARS CoV-2 related acute respiratory distress syndrome.

TFF Pharmaceuticals

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TFF Pharmaceuticals Announces Phase 1 Clinical Trial Progress for Voriconazole Inhalation Powder

Lead Product(s): Voriconazole

Therapeutic Area: Pulmonary/Respiratory Diseases 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 19, 2020

Details:

Successfully completes single ascending dose phase of first clinical study in healthy subjects for a direct-to-lung, Thin Film Freezing (TFF) dry-powder formulation.

BioDelivery Sciences

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BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine’s 36th Annual Meeting

Lead Product(s): Buprenorphine

Therapeutic Area: Pulmonary/Respiratory Diseases 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 February 27, 2020

Details:

BELBUCA effect on respiratory drive was comparable to placebo at all doses tested.The effect of immediate release oral oxycodone HCl resulted in a dose-dependent decrease in respiratory drive.

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Find Drugs for Pulmonary/Respiratory Diseases in Phase I Clinical Development

Phase I

Product Type

Companies

aTyr Pharma

aTyr Pharma Announces Partner Kyorin Pharmaceutical, Co., Ltd. Proceeds to Phase 1 Trial of ATYR1923 in Japan

Renovion

Renovion Announces Completion of $8.1 Million Financing Round Enabling Clinical Programs in Chronic Inflammatory Lung Diseases

Imperial College London

Trevena Announces Collaboration with Imperial College London to Evaluate TRV027 in COVID-19 Patients

Aqualung Therapeutics

Aqualung Therapeutics Gets $2.3 M NIH Fast-Track Award To Develop Novel Therapeutic Antibody For Patients With Radiation-Induced Lung Injury

Cellenkos

Cellenkos Gets FDA Clearance to Initiate Phase 1 Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells for COVID-19 Associated ARDS

NantKwest

NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients

Genkyotex

Genkyotex Receives Approval From the French Medicines Agency (ANSM) to Initiate a Phase 1 Clinical Study With High-dose Setanaxib

Roivant Sciences

Altasciences Completes Phase I Study on Gimsilumab for ARDS in COVID-19

TFF Pharmaceuticals

TFF Pharmaceuticals Announces Phase 1 Clinical Trial Progress for Voriconazole Inhalation Powder

BioDelivery Sciences

BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine’s 36th Annual Meeting