Infections and Infectious Diseases | Phase II Developments | UNITED KINGDOM

Verona Pharma

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Verona Pharma Initiates Pilot Study with PMDI Ensifentrine in U.S. Patients Hospitalized with COVID-19

Lead Product(s): Ensifentrine

Therapeutic Area: Infections and Infectious Diseases Product Name: RPL554

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 08, 2020

Details:

The study will evaluate the effect of ensifentrine on key outcomes in hospitalized COVID-19 patients including facilitation of recovery from the viral infection, clinical status improvement and reduction in supplemental oxygen use and progression to mechanical ventilation.

GlaxoSmithKline

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GlaxoSmithKline Presents Promising Phase 2A Data for Chronic Hepatitis B Treatment

Lead Product(s): GSK3228836

Therapeutic Area: Infections and Infectious Diseases Product Name: GSK3228836

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 28, 2020

Details:

Phase 2a data to be presented at The Digital International Liver Congress suggests potential of investigational drug (GSK3228836) to suppress hepatitis B virus after four weeks of treatment.

F2G Limited

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F2G Raises $61M for Late-Phase Antifungal R&D

Lead Product(s): Olorofim

Therapeutic Area: Infections and Infectious Diseases Product Name: F901318

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Cowen Healthcare Investments

Deal Size: $60.8 million Upfront Cash: Undisclosed

Deal Type: Financing August 12, 2020

Details:

Proceeds from the financing will be used to fund F2G's late-stage clinical programs for their novel antifungal agent olorofim and organisational scale-up in preparation for commercialisation.

Destiny Pharma

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Destiny Pharma’s Novel Antibiotic Asset XF-73 Clears Safety Review

Lead Product(s): Exeporfinium chloride

Therapeutic Area: Infections and Infectious Diseases Product Name: XF-73

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2020

Details:

Positive interim safety review has been completed by an Independent Data Monitoring Committee (IDMC) of the Company’s ongoing Phase 2b study of its lead asset XF-73 in the prevention of post-surgical bacterial infections.

Destiny Pharma

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Destiny Pharma Provides Update on its Phase 2b Clinical Study of XF-73

Lead Product(s): Exeporfinium chloride

Therapeutic Area: Infections and Infectious Diseases Product Name: XF-73

Highest Development Status: Phase II 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:

Destiny Pharma agreed with FDA to reduce Phase 2b study size without compromising its statistical power or clinical value. The study is evaluating XF-73 for the prevention of post-surgical hospital infections caused by Staphylococcus aureus bacteria, such as MRSA.

Synairgen

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Synairgen Provides Clarification Regarding Trial of SNG001 in Hospitalised COVID-19 Patients

Lead Product(s): Interferon Beta-1A

Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

The trial of SNG001 in hospitalised COVID-19 patients is a Phase II trial (as clearly stated in the announcements of 18 and 25 March). A Phase II trial is designed to test the efficacy of a drug and takes place before the drug is approved or able to be marketed.

Synairgen

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Synairgen Shares Soar on COVID-19 Treatment, but Caveats Abound

Lead Product(s): Interferon Beta-1A

Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2020

Details:

The data showed those who were given SNG001 had a 79% lower risk of developing severe disease compared to placebo, according to the biotech, with patients who got that drug also more than twice as likely to recover from COVID-19 than those on a dummy med.

4D Pharma

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Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Lead Product(s): MRx-4DP0004

Therapeutic Area: Infections and Infectious Diseases Product Name: MRx-4DP0004

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2020

Details:

The Phase II randomized, double-blind, placebo-controlled trial is enrolling up to 90 patients admitted to hospital with COVID-19 in the UK. Eligible patients will receive daily oral MRx-4DP0004 or placebo, in addition to standard supportive care.

F2G Limited

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F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis and FDA QIDP Designation for Multiple Fungal Infections

Lead Product(s): Olorofim

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2020

Details:

Following the granting of Breakthrough Therapy designation in November, the U.S. FDA has also granted Qualified Infectious Disease Product (QIDP) designation to its lead first-in-class candidate, olorofim (formerly F901318).

GlaxoSmithKline

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GSK begins US test of experimental drug for pneumonia caused by COVID-19

Lead Product(s): Otilimab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

Details:

GlaxoSmithKline has started a trial in the United States to test an experimental rheumatoid arthritis drug on patients suffering from pneumonia caused by COVID-19.

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Verona Pharma

Verona Pharma Initiates Pilot Study with PMDI Ensifentrine in U.S. Patients Hospitalized with COVID-19

GlaxoSmithKline

GlaxoSmithKline Presents Promising Phase 2A Data for Chronic Hepatitis B Treatment

F2G Limited

F2G Raises $61M for Late-Phase Antifungal R&D

Destiny Pharma

Destiny Pharma’s Novel Antibiotic Asset XF-73 Clears Safety Review

Destiny Pharma

Destiny Pharma Provides Update on its Phase 2b Clinical Study of XF-73

Synairgen

Synairgen Provides Clarification Regarding Trial of SNG001 in Hospitalised COVID-19 Patients

Synairgen

Synairgen Shares Soar on COVID-19 Treatment, but Caveats Abound

4D Pharma

Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

F2G Limited

F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis and FDA QIDP Designation for Multiple Fungal Infections

GlaxoSmithKline

GSK begins US test of experimental drug for pneumonia caused by COVID-19