#ORPH Open Orphan Plc – Positive results from Flu Human Challenge Study

Open Orphan plc (AIM: ORPH) a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, notes the announcement released from SAB Biotherapeutics (NASDAQ: SABS) (“SAB”), reporting positive results from a human challenge study testing SAB-176, its investigational therapeutic for the treatment of seasonal influenza. hVIVO, a subsidiary of Open Orphan, conducted the Phase 2a randomised, double-blinded, placebo-controlled study using its Influenza Human Challenge Study Model.

The trial evaluated the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza strain (pH1N1). Participants were intranasally inoculated with the influenza challenge virus and then randomised to receive either SAB-176 or placebo.. SAB-176 achieved statistically significant (p = 0.026) reductions in viral load. Based on partial data, statistically significant reductions in clinical signs and symptoms compared to placebo were also observed. Additionally, no serious adverse events were reported and SAB-176 appeared to be safe and well tolerated. Based on the positive results from this study, SAB plans to further evaluate SAB-176 in a Phase 2 influenza clinical trial.

Flu is caused by the influenza virus and is one of the most common infectious respiratory diseases and can lead to severe illness, and death. There are four types of seasonal influenza viruses, types A, B, C and D. Influenza A and B viruses circulate and cause seasonal epidemics of disease. According to the World Health Organisation (WHO), worldwide, these annual epidemics are estimated to result in about three to five million cases of severe illness, and about 290 000 to 650 000 respiratory deaths.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including respiratory syncytial virus (RSV), Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said : “I am pleased that SAB has received positive results for SAB-176 from its influenza human challenge trial, conducted by hVIVO. SAB-176 met its primary endpoint and based on partial data appears to have met a key secondary endpoint. These encouraging results support proceeding to a Phase 2 clinical trial.

“Influenza affects a significant proportion of the global population every year with symptoms ranging from mild to severe, with hospitalisations and deaths occurring among high-risk groups. hVIVO has successfully been delivering Influenza human challenge trials for over two decades, and we look forward to continuing to support Big Pharma and biotechs to provide early proof-of-concept for novel vaccines and antivirals.”

Mariya Kalinova, Medical Director, hVIVO, commented: “We are delighted to see these positive results from the Phase 2a Influenza Human Challenge Study for SAB Biotherapeutics’ novel anti-influenza human immunotherapy, SAB-176. The encouraging reductions in viral load and clinical symptoms, along with the promising safety and tolerability data observed in this challenge study suggest SAB-176 may have a positive impact on individuals with influenza.

“This successful study demonstrates the way that Phase 2a challenge studies can help advance drug development and provide a value inflection point for innovative products such as SAB-176 as they move towards a full Phase 2 study. Moving forward, we expect to see an increase in the number of human challenge studies taking place across multiple infectious diseases, as interest in these disease areas continues to grow.”  

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