Infections and Infectious Diseases | IND Enabling Drugs | UNITED STATES

Diffusion Pharmaceuticals

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Diffusion Pharmaceuticals Receives FDA Guidance for International Phase 1b/2b COVID-19 Clinical Program with TSC

Lead Product(s): Transcrocetinate sodium

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

NAMMD has regulatory oversight over the Company’s first planned clinical trial, an open-label Phase 1b lead-in trial in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID).

Onconova Therapeutics

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Onconova Therapeutics Submits Application For Rigosertib To Participate In Federally Funded Human Studies In COVID-19 Disease

Lead Product(s): Rigosertib

Therapeutic Area: Infections and Infectious Diseases Product Name: ON-01910

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

Onconova Therapeutics has submitted an application with the National Institute of Allergy and Infectious Disease (NIAID), with the goal of obtaining funding from the National Institutes of Health (NIH) to conduct human studies with rigosertib in COVID-19 disease patients.

Cidara Therapeutics

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Cidara Therapeutics Announces Formation of Scientific Advisory Board

Lead Product(s): CD377

Therapeutic Area: Infections and Infectious Diseases Product Name: CD377

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

The SAB will work closely with the Cidara management team to help guide the direction and design of the company’s development programs with an emphasis on the continued development and expansion of the company’s Cloudbreak Antiviral Conjugate (AVC) program.

ContraFect Corporation

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ContraFect Announces up to $18.9 Million in Funding from CARB-X to Support Acceleration of the CF-370 Program

Lead Product(s): CF-370

Therapeutic Area: Infections and Infectious Diseases Product Name: CF-370

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: CARB-X

Deal Size: $18.9 million Upfront Cash: Undisclosed

Deal Type: Funding July 20, 2020

Details:

This CARB-X funding is aimed at progressing ContraFect's second product candidate, CF-370, an engineered lysin targeting Pseudomonas aeruginosa (P. aeruginosa), in IND-enabling activities toward future Phase 1 clinical trials.

Akebia Therapeutics

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Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for COVID-19

Lead Product(s): Vadadustat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2020

Details:

The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients who have been hospitalized at Memorial Hermann-Texas Medical Center for hypoxemia due to COVID-19.

Diffusion Pharmaceuticals

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Diffusion Pharmaceuticals Files IND for International Phase 1b/2b COVID-19 Clinical Program With TSC

Lead Product(s): Transcrocetinate sodium

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

Details:

The new IND details three studies, comprised of an open-label Phase 1b lead-in trial which, if successful, will be followed by two randomized double-blinded Phase 2b trials.

Aridis Pharmaceuticals

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Aridis Pharmaceuticals to Discuss APEX™ in Virtual Fireside Chat Hosted by Cantor Fitzgerald on June 25th

Lead Product(s): AR-701

Therapeutic Area: Infections and Infectious Diseases Product Name: AR-701

Highest Development Status: IND Enabling 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:

The discussion is intended to provide a comprehensive profile of the Company's CRISPR based, new platform technology APEX™.

iBio

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iBio Announces Second COVID-19 Vaccine Program

Lead Product(s): IBIO-201

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 04, 2020

Details:

The new subunit vaccine (“IBIO-201”) combines antigens derived from the SARS-CoV-2 spike protein fused with the Company’s patented lichenase booster molecule (“LicKM”), which is designed to enhance immune response.

Altimmune

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Altimmune Launches Clinical Trial of T-COVIDTM, Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19

Lead Product(s): T-COVID

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19.

NanoViricides

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NanoViricides Completes $10.2 Million Registered Direct Offering Funds to Accelerate COVID-19 Drug Program and HerpeCide Program

Lead Product(s): NV-HHV-101

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Maxim Group LLC

Deal Size: $10.2 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 26, 2020

Details:

Funds to be used to further advance company's first drug candidate for Shingles through initial human clinical trials, and advance additional HerpeCide™ program candidates against HSV-1 and HSV-2, towards clinical candidate selection.

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Find FDA Investigational New Drug (IND) Submissions for Infections and Infectious Diseases in UNITED STATES

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Companies

Diffusion Pharmaceuticals

Diffusion Pharmaceuticals Receives FDA Guidance for International Phase 1b/2b COVID-19 Clinical Program with TSC

Onconova Therapeutics

Onconova Therapeutics Submits Application For Rigosertib To Participate In Federally Funded Human Studies In COVID-19 Disease

Cidara Therapeutics

Cidara Therapeutics Announces Formation of Scientific Advisory Board

ContraFect Corporation

ContraFect Announces up to $18.9 Million in Funding from CARB-X to Support Acceleration of the CF-370 Program

Akebia Therapeutics

Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for COVID-19

Diffusion Pharmaceuticals

Diffusion Pharmaceuticals Files IND for International Phase 1b/2b COVID-19 Clinical Program With TSC

Aridis Pharmaceuticals

Aridis Pharmaceuticals to Discuss APEX™ in Virtual Fireside Chat Hosted by Cantor Fitzgerald on June 25th

iBio

iBio Announces Second COVID-19 Vaccine Program

Altimmune

Altimmune Launches Clinical Trial of T-COVIDTM, Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19

NanoViricides

NanoViricides Completes $10.2 Million Registered Direct Offering Funds to Accelerate COVID-19 Drug Program and HerpeCide Program