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

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            Lead Product(s): Ampion

            Therapeutic Area: Infections and Infectious Diseases

            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.

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            Lead Product(s): Merimepodib,Remdesivir

            Therapeutic Area: Infections and Infectious Diseases

            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.

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            Lead Product(s): Merimepodib,Remdesivir

            Therapeutic Area: Infections and Infectious Diseases

            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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            Lead Product(s): CC-42344

            Therapeutic Area: Infections and Infectious Diseases

            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 May 11, 2020

            Details:

            The Company’s lead molecule in development, CC-42344, is currently being evaluated in preclinical IND-enabling studies for the treatment of influenza. CC-42344 has shown excellent antiviral activity against influenza A strains.

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            Lead Product(s): Trabedersen

            Therapeutic Area: Infections and Infectious Diseases

            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 April 27, 2020

            Details:

            The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US.

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            Lead Product(s): Merimepodib

            Therapeutic Area: Infections and Infectious Diseases

            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 April 24, 2020

            Details:

            The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in COVID-19 patients. In vitro studies show decrease of viral production by over 98%.

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            Lead Product(s): CLBS119

            Therapeutic Area: Infections and Infectious Diseases

            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 April 23, 2020

            Details:

            U.S. Food and Drug Administration has authorized its investigational new drug application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage.

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            Lead Product(s): ATYR1923

            Therapeutic Area: Infections and Infectious Diseases

            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 April 21, 2020

            Details:

            Phase 2 clinical trial will be a randomized, double blind, placebo-controlled study with ATYR1923 in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Infections and Infectious Diseases

            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 April 20, 2020

            Details:

            Study will evaluate the impact of ULTOMIRIS, a biologic medicine, on survival, duration of mechanical ventilation, and hospital stay compared to best supportive care.

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            Lead Product(s): 7HP349

            Therapeutic Area: Infections and Infectious Diseases

            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 April 14, 2020

            Details:

            U.S. FDA has cleared the company’s investigational new drug application for 7HP349. The FDA completed its 30-day safety review and granted approval to proceed with Phase 1 healthy volunteer study.

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