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Details:
PMX63 (brilacidin) is a de novo-designed synthetic, non-peptidic, small molecule that kills pathogens swiftly, greatly reducing the likelihood of drug resistance developing. It also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX63
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2023
Details:
The new PMX63 (brilacidin) findings in fungal keratitis complement an earlier in vitro and in vivo evaluation of Brilacidin as an ocular anti-infective in bacterial keratitis.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX63
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
In pre-clinical studies, PMX63 (brilacidin) shown to synergize with marketed antifungals against pathogenic species of aspergillosis, candidiasis, cryptococcosis and mucormycosis, and further exhibited potent stand-alone efficacy against Cryptococcus neoformans.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX63
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2022
Details:
Innovation Pharmaceuticals remains optimistic about Brilacidin, even Phase 2 COVID-19 clinical trial did not meet its primary endpoint. Brilacidin a novel drug candidate proven to have antibiotic, anti-inflammatory and antiviral properties.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2021
Details:
Brilacidin, a defensin mimetic, with potential antimicrobial and anti-mucositic activities used in hospitalized patients with moderate-to-severe COVID-19. Brilacidin is being developed for treatment of COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
Company has received confirmation that hard lock of the database was completed for its Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2021
Details:
Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with laboratory testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad-spectrum antiviral.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
Based on pre-clinical studies, Brilacidin is exhibiting an ability to directly disrupt viral integrity, a potent virucidal property, enabling it to be unaffected by mutations that give rise to variants-a beneficial trait differentiating Brilacidin from other antivirals.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
Details:
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
In Phase 2, ~120-patient, randomized, double-blind, placebo-controlled clinical trial evaluating Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. Early in April, enrollment in the trial reached 25 percent.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2021
Details:
Enrollment has surpassed 50 percent of the total targeted number of randomized trial participants (~n=120) in its double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
Brilacidin, Company’s defensin-mimetic drug candidate, potently inhibits both coronaviruses and alphaviruses.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2021
Details:
DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company has since implemented.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2021
Details:
Innovation Pharma reports that eight sites are now participating in the Company’s international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2021
Details:
The Phase 2 Brilacidin for COVID-19 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
The company believes that Brilacidin would be less prone to resistance developing due to viral mutations due to its ability to attack the coronavirus directly by disrupting viral membrane integrity.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX-30063
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
the U.S. FDA has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein mimetic with antiviral, anti-inflammatory and antibacterial properties.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2021
Details:
The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now finalizing the trial protocol for its planned Phase 2 study to evaluate the efficacy & safety of Brilacidin in hospitalized COVID patients.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
In testing at GMU’s BSL-3 lab, Brilacidin potently inhibits SARS-CoV-2 in vitro against the live virus. The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry.
Lead Product(s): Brilacidin,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: George Mason University
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2020
Details:
In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2.
Lead Product(s): Brilacidin,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
Preliminary data shows Brilacidin’s Selectivity Index (SI), a ratio that compares a drug’s cytotoxicity and antiviral activity, to be greater than 300 in a human lung epithelial cell line.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
A new experiment in a human lung epithelial cell line with the live (or wild type) virus showed that Brilacidin inhibited SARS-CoV-2 when administered post-infection.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: PMX30063
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2020
Details:
Recently released in vitro data showed Brilacidin exhibited a potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line—reducing viral load by 95 percent and 97 percent at two efficacious concentrations tested, compared to control (DMSO).
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2020
Details:
As previously disclosed, Brilacidin is being evaluated at a U.S. Regional Biocontainment Laboratory (RBL) and has consistently demonstrated robust in vitro antiviral properties against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovation Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 11, 2020
Details:
Anti-SARS-CoV-2 (COVID-19) drug candidate, Brilacidin, in an in vitro experiment using VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour of preincubation prior to infection at a concentration of 10μM as compared to vehicle control.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2020
Details:
MTA aims at accessing Brilacidin’s inhibitory effect on SARS-CoV-2 viral replication in primary immune mediators obtained from young and old donors to check age-dependent host responses to Covid-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 05, 2020
Details:
Company reviewed the discovery and development process of broad-spectrum antiviral agents and summarized the information on 120 safe-in-man agents in a freely accessible database.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2020
Details:
The ability to penetrate cell walls engenders confidence in this opportunity to meet an urgent medical need in treating coronaviruses like COVID-19.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2020
Details:
The Company is presently interviewing Contract Research Organizations for site selection with the understanding that the goal is to initiate the trial this summer.
Lead Product(s): Brilacidin
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2020
Details:
Under terms of the agreement, Brilacidin’s potential inhibition of SARS-CoV-2, the virus responsible for COVID-19 is planned to be assessed.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovation Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 24, 2020
Details:
Brilacidin already has demonstrated broad and robust antibacterial, anti-inflammatory and immunomodulatory properties in multiple FDA clinical trials.
Lead Product(s): Brilacidin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2020
Details:
Preliminary top-line data from its Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints.
Lead Product(s): Brilacidin
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
This renewed engagement is a continuation of Innovation Pharmaceutical’s business relationship with Locust Walk toward realizing the market potential of the Company’s pipeline.
Lead Product(s): Brilacidin
Therapeutic Area: Dental and Oral Health Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovation Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 29, 2020
Details:
Brilacidin utilizing new delayed release technology for targeted delivery directly to colon.
Lead Product(s): Brilacidin
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2020
Details:
The start of this Phase 1 trial is a major milestone for the Company, a key part of its broader clinical program in Inflammatory Bowel Diseases (IBD).
Lead Product(s): Brilacidin
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2020
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