SYNAIRGEN


Associated tags: COVID-19, Health, Drug discovery, Vaccine, Pharmaceutical industry, University, Inhalation, University of Southampton, Safety, AIM, Synairgen, FDA, Patient, Food, LSE, Severe acute respiratory syndrome coronavirus 2, Research, Clinical Trials, Degenerative disease, EU

Synairgen announces positive data from the US NIH-led ACTIV-2 Phase 2 trial for SNG001 in home-based participants with COVID-19

Retrieved on: 
Tuesday, October 4, 2022

There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.

Key Points: 
  • There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.
  • Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial in October 2021.
  • We will now begin to evaluate the full data set and factor these findings into our development plans.
  • 2 Synairgen conducted a trial of SNG001 in high-risk, home-based COVID-19 patients (SG016) in which fewer patients treated with SNG001 were hospitalised (0/56) compared to placebo (2/58).

Synairgen to Present 60 and 90-day Long COVID Data From Phase 3 SPRINTER Study in Hospitalised COVID-19 Patients at IDWeek 2022

Retrieved on: 
Tuesday, September 20, 2022

Professor Chris Brightling, NIHR Senior Investigator, Department of Respiratory Sciences at the University of Leicester, said: This promising Long COVID data is very welcome in an area of enormous clinical need.

Key Points: 
  • Professor Chris Brightling, NIHR Senior Investigator, Department of Respiratory Sciences at the University of Leicester, said: This promising Long COVID data is very welcome in an area of enormous clinical need.
  • We look forward to presenting the results at IDWeek in October.
  • Long-COVID symptoms (checklist) were assessed as a secondary endpoint at follow-up visits via telephone/video call on Day 60 and Day 90.
  • SNG001 has broad potential applicability for patients hospitalised with respiratory symptoms due to viral infections such as SARS-CoV-2, complicated influenza, RSV, adenovirus, para-influenza and rhinoviruses.

Synairgen announces positive findings from analysis of lung samples from the SG015 trial of SNG001 in virally infected COPD patients

Retrieved on: 
Wednesday, September 7, 2022

In early 2020, due to the emergence of SARS-CoV-2, Synairgens SG015 trial in COPD patients was paused with 109 out of the targeted 120 patients recruited.

Key Points: 
  • In early 2020, due to the emergence of SARS-CoV-2, Synairgens SG015 trial in COPD patients was paused with 109 out of the targeted 120 patients recruited.
  • In the second week of treatment, a greater proportion of patients in the placebo group had purulent sputum or elevated serum CRP.
  • In 2018 Synairgen commenced a two-part COPD trial (SG015; NCT03570359) to assess initially, the safety and lung antiviral biomarker responses to SNG001 in the absence of viral infection.
  • In the first part of the trial SNG001 was well tolerated in patients with moderate to severe COPD.

Synairgen Presents Detailed Analysis of Phase 3 SPRINTER Trial Evaluating SNG001 in Hospitalised COVID-19 Patients at ATS 2022

Retrieved on: 
Monday, May 16, 2022

The trial recruited a total of 623 patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on top of standard of care (SOC).

Key Points: 
  • The trial recruited a total of 623 patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on top of standard of care (SOC).
  • Synairgen announced in February 2022 that the Phase 3 SPRINTER trial did not meet the primary endpoints of discharge from hospital and recovery.
  • The full analysis of the Phase 3 SPRINTER trial data will be submitted for publication in a peer-reviewed journal.
  • This was reported as 27.1% in the topline analysis in February 2022 but changed between 35- and 90-day database lock.

Akron Biotech Signs Agreement With Synairgen plc to Supply Interferon-beta for COVID-19 Treatment

Retrieved on: 
Monday, October 19, 2020

Akron Biotechnology today announced it has signed an agreement with Synairgen plc (LSE: SNG) for the provision of SNG001, Synairgens wholly-owned inhaled interferon beta (IFN-beta) therapeutic candidate for the treatment of COVID-19 patients.

Key Points: 
  • Akron Biotechnology today announced it has signed an agreement with Synairgen plc (LSE: SNG) for the provision of SNG001, Synairgens wholly-owned inhaled interferon beta (IFN-beta) therapeutic candidate for the treatment of COVID-19 patients.
  • Akron Biotech provides cGMP-compliant solutions to support the development and commercialization of advanced therapies.
  • Akron will support the future clinical and commercial development of SNG001 through the provision of its IFN-beta in Synairgens formulation.
  • The agreement with Synairgen reflects our ongoing commitment to meet the growing demand for validated, cGMP-compliant solutions to advance novel therapies, said Claudia Zylberberg, PhD, Founder and CEO of Akron Biotech.