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Details:
The Company intends to use the net proceeds for its ongoing SHIELD II phase 3 clinical trial evaluating D-PLEX100 (extended release doxycycline hyclate formulation) for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: JMP Securities
Deal Size: $16.2 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 04, 2024
Details:
D-PLEX100 (doxycycline hyclate) is polyPid’s lead product candidate, designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 18, 2023
Details:
D-PLEX100 (doxycycline hyclate) is polyPid’s lead product candidate, designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 June 22, 2023
Details:
D-PLEX100 (doxycycline hyclate) is polyPid’s lead product candidate, designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 May 22, 2023
Details:
PolyPid intends to use the net proceeds from the Public Offering to fund the ongoing clinical activities and development of D-PLEX100 (doxycycline hyclate). D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal colorectal surgical site infections.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Newbridge Securities Corporation
Deal Size: $7.1 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 31, 2023
Details:
PolyPid intends to use the net proceeds from the Public Offering to fund the ongoing clinical activities and development of D-PLEX100 (doxycycline hyclate). D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal colorectal surgical site infections.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Newbridge Securities Corporation
Deal Size: $6.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 29, 2023
Details:
PolyPid intends to use the net proceeds from the private placement to fund the ongoing clinical activities and development of D-PLEX100 (doxycycline hyclate). D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal colorectal surgical site infections.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Newbridge Securities Corporation
Deal Size: $4.4 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 29, 2023
Details:
D-PLEX100 (doxycycline hyclate) is polyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 January 24, 2023
Details:
D-PLEX100 (Doxycycline hyclate), is designed to provide local prolonged release and controlled activity of the broad-spectrum antibiotic doxycycline directly at the surgical site to prevent surgical site infections (SSIs).
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 January 03, 2023
Details:
D-PLEX100 having doxycycline hyclate, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 December 12, 2022
Details:
D-PLEX100 (doxycycline hyclate), delivers a broad-spectrum antibiotic, doxycycline, generating high local concentration, is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 November 29, 2022
Details:
D-PLEX100 (doxycycline hyclate), PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 28, 2022
Details:
The SSI rate (superficial and deep) within 30 day post-index surgery showed a 64% statistically significant relative risk reduction in the D-PLEX100 (doxycycline hyclate) plus SoC cohort at 8% infection rate [n=7/88] compared to 22% infection rate in the SoC alone cohort.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 19, 2022
Details:
In FDA Requested Pre-specified Subgroup Analysis in Subjects with Incision Lengths over 20 centimeters, D-PLEX100 (doxycycline hyclate) + SoC Achieved a Statistically Significant Reduction of 54 percent on the Primary Endpoint versus SoC alone.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 02, 2022
Details:
ADVANZ PHARMA receives the exclusive rights for the commercialization of PolyPid’s lead drug candidate, D-PLEX100 (doxycycline hyclate) for the prevention of surgical site infections (“SSIs”) in abdominal and cardiac surgeries, in Europe.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $112.5 million Upfront Cash: $2.6 million
Deal Type: Licensing Agreement August 03, 2022
Details:
Primary efficacy endpoint for D-PLEX100 (doxycycline hyclate), showed decrease of infection rate as measured by the proportion of subjects with at least one sternal infection within 90 days post cardiac surgery.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 25, 2022
Details:
Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation,’ evaluates the effect of D-PLEX100 (Doxycycline Hyclate) in combination with surgical site infection soc prophylaxis regimen in elective colorectal surgery.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 June 06, 2022
Details:
D-PLEX100, PolyPid’s lead Doxycycline Hyclate candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 May 31, 2022
Details:
Presentation evaluates the effect of D-PLEX100, Doxycycline (broad-spectrum antibiotic) in limiting occurrence of antimicrobial resistance (AMR) in colorectal surgery patients.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 April 25, 2022
Details:
DPLEX100, a novel doxycycline formulation provides high, local concentrations of antibiotic activity for approximately four weeks to reduce surgical site infections added to standard of care prophylaxis regimens for elective colorectal surgery.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 March 08, 2022
Details:
PolyPid’s lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 March 02, 2022
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).
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
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 December 16, 2020
Details:
PolyPid's lead candidate D-PLEX100 is currently in a Phase 3 trial for bone surgical site infections (SSIs) and the company is planning to initiate a Phase 3 trial for abdominal SSIs set to begin in the 3Q 2020.
Lead Product(s): Doxycycline Hyclate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aurum Ventures
Deal Size: $58.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 05, 2020
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