Infections and Infectious Diseases | IND Enabling Drugs

Revive Therapeutics

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Revive Therapeutics Announces Submission of IND with U.S. FDA for Phase 3 Confirmatory Study for Bucillamine in COVID-19

Lead Product(s): Bucillamine

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 June 30, 2020

Details:

The Phase 3 confirmatory clinical will enroll up to 800 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day, Bucillamine 200 mg TID or placebo TID for up to 14 days.

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.

Revive Therapeutics

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Revive Therapeutics Files Pre-CTA Meeting Request with Health Canada and Update on IND Filing and Phase 3 Clinical Trial Design for Bucillam...

Lead Product(s): Bucillamine

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 June 03, 2020

Details:

Company has filed its Clinical Trial Application with Health Canada and provides an update on the filing of its IND package to the U.S. FDA for the proposed Phase 3 clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19.

FSD Pharma

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FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial To Treat Patients With Suspected or Confirmed Covid-19 Diagnosis

Lead Product(s): Palmitoylethanolamide

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 June 03, 2020

Details:

The trial will be a randomized, controlled, double-blind, U.S. multicenter study to assess the efficacy and safety of FSD-201 dosed 600mg/1200mg twice-daily plus standard of care versus SOC alone in symptomatic patients with clinical presentation compatible with COVID-19.

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.

Ampio Pharmaceuticals

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Ampio Provides Update on COVID-19 Program

Lead Product(s): Ampion

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

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 May 22, 2020

Details:

Ampio has filed Investigative New Drug ("IND") applications for Ampion™ with the FDA and has maintained ongoing dialog with the FDA regarding the Company's development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.

BioSig Technologies

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ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib

Lead Product(s): Merimepodib,Remdesivir

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Laidlaw & Company

Deal Size: $10.8 million Upfront Cash: Undisclosed

Deal Type: Financing May 20, 2020

Details:

ViralClear plans to use the proceeds of this offering for the development, including phase II human clinical trials, of its product candidate merimepodib, a broad-spectrum anti-viral agent.

BioSig Technologies

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FDA Clears the IND Application to Enable the Phase II Trial of ViralClear’s Merimepodib to Treat Advanced COVID-19

Lead Product(s): Merimepodib,Remdesivir

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 May 18, 2020

Details:

The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.

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

IND Enabling

Product Type

Companies

Revive Therapeutics

Revive Therapeutics Announces Submission of IND with U.S. FDA for Phase 3 Confirmatory Study for Bucillamine in COVID-19

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

Revive Therapeutics

Revive Therapeutics Files Pre-CTA Meeting Request with Health Canada and Update on IND Filing and Phase 3 Clinical Trial Design for Bucillam...

FSD Pharma

FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial To Treat Patients With Suspected or Confirmed Covid-19 Diagnosis

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

Ampio Pharmaceuticals

Ampio Provides Update on COVID-19 Program

BioSig Technologies

ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merimepodib

BioSig Technologies

FDA Clears the IND Application to Enable the Phase II Trial of ViralClear’s Merimepodib to Treat Advanced COVID-19