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Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
U.S. Phase 3 study underway to evaluate RHB-204 as a first-line, stand-alone, oral treatment for pulmonary NTM disease - a rare condition with no FDA-approved first-line therapy.
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Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
First patient has been enrolled and randomized in the SHIELD II trial, the Company’s second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).
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Lead Product(s): Doxycycline Monohydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
The designation is based on conclusive positive results from a Phase 2 trial of D-PLEX100 for the prevention of surgical site infections in abdominal colorectal surgery. D-PLEX100 significantly decreased in SSIs of 59% in the Intent to Treat population.
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Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2020
Details:
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy.
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Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: M-001
Highest Development Status: Phase III Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints.
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Lead Product(s): Doxycycline Monohydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
PolyPid's D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.
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Lead Product(s): Doxycycline Monohydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase III 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:
CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity.
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Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: M-001
Highest Development Status: Phase III Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate and severity, as well as to assess M-001's safety.
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Lead Product(s): Doxycycline Monohydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
SHIELD I is a multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy & safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC) vs SoC-treated control arm, to prevent post- abdominal surgery incisional infection.
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Lead Product(s): Proglumide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA.
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