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Details:
Tempol (MMB-02) capsule, is a redox cycling nitroxide in development for the treatment of patients with COVID-19, was the subject of a Phase 2/3 clinical trial which has been halted.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2022
Details:
This trial did not meet its primary endpoint, but we are exploring the possibility that vaccinations and the less virulent variants (Omicron) during the trial period may have obscured an effect of Tempol (MMB-02).
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
Tempol (MMB-02) is a redox cycling nitroxide that promotes the metabolism of many reactive oxygen species and improves nitric oxide bioavailability. It has been studied extensively in animal models of oxidative stress and inflammation.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
The results of published study suggesting that MMB-02 (tempol) Capsule has strong, broad in-vitro anti-cytokine activity. Suppression of inflammatory cytokines with an antioxidant may be a beneficial treatment strategy in early COVID-19 infection.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Stanford University
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Hamsters challenged with high levels of the Omicron variant of the SARS-CoV-2 virus, resulted in a significant decrease in inflammation in the lungs of animals treated with Tempol (MBM-02), a novel antioxidant, compared to controls.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Galveston National Laboratory
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Data Safety Monitoring Board met to evaluate interim clinical and safety data and clears, from the first planned interim analysis Phase 2/3 study to continue for Tempol, for the treatment of COVID-19.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
Details:
As part of the initial phase 2 portion of the study, 50 COVID positive subjects with comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection will be randomized 1:1 to receive either Tempol or placebo.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
Details:
Preclinical studies of Tempol have shown it to have antiviral, anti-inflammatory, and antioxidant activity. The Company believes this unique mechanism of action, combined with the benign safety profile shown in preclinical and ongoing clinical studies.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2022
Details:
Tempol, a novel antioxidant is currently being studied in a Phase 2/3 clinical trial in adult patients with confirmed COVID-19 infection, used in the treatment of a patient with respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Human Immune Monitoring Center at Stanford University
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
Recent studies conducted by NIH researchers suggested that Tempol had potent antiviral activity against the virus that causes COVID-19 in laboratory studies.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: MBM-02
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2021
Details:
Tempol demonstrated an ability to limit SARS-CoV-2 infection by impairing the activity of a viral enzyme known as RNA replicase. The Stanford study suggested Tempol may prevent the cytokine storm observed in COVID-19 patents.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
The Phase 2/3, adaptive, randomized, double-blind, placebo-controlled study will examine the effects of Tempol (MBM-02) on preventing covid-19 related hospitalization in subjects with covid-19 infection.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: APC-410
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
To study Tempol in treating and preventing Covid-19, Adamis intends to pursue government and / or non-government funding.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Tempol
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2021
Details:
The FDA’s response now allows Adamis to proceed to the next step of formally submitting an IND for Tempol, and at the same time, begin formal applications for funding to governmental agencies to support the clinical trial and large-scale manufacturing.
Lead Product(s): Tempol
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 August 14, 2020
Details:
The license includes the worldwide use of Tempol for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.
Lead Product(s): Tempol
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adamis Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 15, 2020
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