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Details:
There were no significant differences between SNG001, a pH-neutral formulation of interferon-beta for inhalation that is delivered directly into the lungs using a mesh nebuliser. and placebo with respect to primary outcomes of safety, symptom resolution, or virology.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2022
Details:
SNG001 is a pH-neutral formulation of IFN-beta for inhalation that is delivered directly into the lungs using a mesh nebuliser, which the Company is developing as a potential host-directed antiviral treatment for patients hospitalised with severe viral lung infections.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
The results suggest that HRV was cleared more rapidly in patients treated with SNG001 (Interferon Beta-1a) than placebo with a statistically significant difference in the proportion of patients with detectable HRV in sputum at Day 7 (post hoc analysis).
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
The collaboration on the UNIVERSAL trial will help provide a better understanding of SNG001 (interferon beta-1) to predict clinical outcomes in patients hospitalised with respiratory symptoms due to infection with a range of respiratory viruses.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of Southampton
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 05, 2022
Details:
SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta for the treatment of patients hospitalized Due to COVID-19.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
In vitro studies conducted at Viroclinics-DDL in the Netherlands have shown that SNG001 has potent antiviral activity against SARS-CoV-2 Delta and Omicron variants at concentrations that are readily achievable following inhaled delivery of interferon beta.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
SNG001 is being investigated for possible use in COVID-19 patients. SNG001 has been administered to hospitalised patients on top of standard of care which changed substantially between the Phase 2 and Phase 3 trials.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2022
Details:
SG018 Phase 3 trial is a randomised, double-blind, placebo-controlled study being conducted in 17 countries evaluating SNG001 for the treatment of hospitalised COVID-19 patients. Upon successful completion of the Phase III study, the company plans to file EUA with the USFDA.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
The agreement clarifies Faron's intellectual property position in the U.S. ahead of any launch of Traumakine for the treatment of capillary leak and systemic inflammatory response syndromes including acute respiratory distress syndrome (ARDS) in the U.S.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Traumakine
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 14, 2021
Details:
In the Phase II portion of the study, SNG001 will be evaluated in up to 220 participants across multiple US sites, with a positive result leading into the Phase III portion of the study.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2021
Details:
Synairgen has completed the recruitment of 120 subjects in its Phase II trial of an inhaled formulation of interferon-beta-1a (SNG001) for treating ‘at risk’ Covid-19 patients in the home setting.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2021
Details:
First patient has been dosed in the UK as part of its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
Synairgen’s SNG001 among the many potential treatments and vaccines to be delivered via Aerogen’s aerosol drug delivery system .
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Aerogen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 23, 2020
Details:
Synairgen’s study will evaluate the ability of SNG001, an inhaled formulation of IFN-beta-1a, to accelerate recovery among hospitalized patients receiving oxygen.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Synairgen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 20, 2020
Details:
Akron will support the future clinical and commercial development of SNG001 through the provision of its IFN-beta in Synairgen’s formulation.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Synairgen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 19, 2020
Details:
The collaboration will be working to progress SNG001 through the required clinical and regulatory channels to make this potentially critical treatment widely available to COVID-19 patients around the world.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Synairgen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 29, 2020
Details:
Action is being taken after an interim review of safety data by the study’s DSMB found an imbalance of serious adverse events among patients on high-flow oxygen/non-invasive mechanical ventilation who received interferon beta-1a vs those who did not receive interferon beta-1a.
Lead Product(s): Interferon Beta-1A,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
SNG001 was well tolerated during the treatment period in a study population that was elderly (mean age 66 years) and suffering from reduced respiratory function, as measured by forced expiratory volume in one second.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
The Company will present 54 abstracts at the meeting, taking place virtually from September 11-13, 2020, including new efficacy and real-world safety data on MAVENCLAD® (cladribine) tablets and new safety data for Rebif® (interferon beta-1a).
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Neurology Product Name: Rebif
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
ACTT began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc, of Foster City, California.
Lead Product(s): Interferon Beta-1A,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 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.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct 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 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.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: SNG001
Highest Development Status: Phase IIProduct 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 new trial is an expansion of the original hospital-based SG016 study. SNG001 is an inhaled formulation of interferon-beta-1a, a natural protein associated with the body’s antiviral responses.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2020
Details:
Detailed analyses following INTEREST trial conclude glucocorticoids block the upregulation of CD73 in the lung capillaries and inhibit interferon signalling.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
Details:
Global Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia program that includes intravenous interferon beta-1a as a new treatment arm has been approved.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2020
Details:
Company has received expedited approvals from the MHRA and Health Research Authority to conduct a trial of SNG001 in COVID-19 patients to potentially assist with the global outbreak of the virus.
Lead Product(s): Interferon Beta-1A
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
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