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Details:

SMT19969 (ridinilazole) is a targeted-spectrum antimicrobial that shows potential in treatment of initial C difficile infection and in providing sustained benefit through reduction in disease recurrence.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2022

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Ridinilazole is the investigational first-in-class drug that completed enrollment of a Phase III clinical trial, Ri-CoDIFy. The primary endpoint of this trial seeks to demonstrate the superiority of ridinilazole in sustained clinical response as compared to vancomycin.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2021

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Ridinilazole is our investigational drug currently in Phase III Ri-CoDIFy clinical trials with the goal of use as first-line therapy to treat initial infection and reduce recurrence of Clostridioides difficile infection.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2021

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Funds to be used for continued patient enrolment into the Ri-CoDIFy Phase 3 clinical trial program of ridinilazole; Preparatory activities to support the commercial launch of ridinilazole; Development of early-stage research projects using Discuva Platform.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Polar Capital

Deal Size: $50.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement November 06, 2020

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Funds support continued patient enrolment into the Ri-CoDIFy Phase 3 clinical trial program of ridinilazole for the treatment of Clostridium difficile infection; launch of Ridinilazole and Development of early-stage research projects using the Company’s Discuva Platform.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $50.0 million Upfront Cash: Undisclosed

Deal Type: Financing October 02, 2020

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The data demonstrated that ridinilazole’s microbiome preservation resulted in a gut environment expected to inhibit the growth of C. difficile. In contrast, vancomycin treatment resulted in a gut environment that may more highly favor the growth of C. difficile.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2020

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The milestone payment was initiated by Summit achieving its initial patient enrolment target at trial sites in Latin America in the Phase 3 clinical trials of ridinilazole for C. difficile infection.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Eurofarma Laboratorios S.A

Deal Size: $3.8 million Upfront Cash: Undisclosed

Deal Type: Collaboration February 06, 2020

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The additional funding is being provided to support a new clinical trial in adolescent patients and brings the total value of the award to up to $72.5 million.


Lead Product(s): Ridinilazole

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Biomedical Advanced Research and Development Authority

Deal Size: $72.5 million Upfront Cash: Undisclosed

Deal Type: Funding January 23, 2020

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