Open Orphan (ORPH ) has acknowledged positive results from a recent human challenge study testing SAB-176, an investigational therapeutic aimed at treating seasonal influenza.
Today, the specialist pharmaceutical company noted a statement made by NASDAQ-listed SAB Biotherapeutics, a biopharmaceutical firm focused on developing immunotherapies.
hVIVO, a subsidiary of London-listed 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 virus and then randomised to receive either SAB-176 or placebo.
SAB-176, SAB Biotherapeutic’s investigational therapeutic which is being developed for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and clinical signs and symptoms compared to placebo in a Phase 2a challenge study.
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 Biotherapeutic has informed investors that it plans to further evaluate SAB-176 in a further Phase 2 influenza clinical trial.
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 viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.
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.”
Mariya Kalinova, Medical Director of hVIVO, said” “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.”
Kalinova said the successful study was demonstrative of the way that Phase 2a challenge studies can help advance drug development and therefore “provide a value inflection point for innovative products such as SAB-176 as they move towards a full Phase 2 study.”
hVIVO said it expects to see a rise in the number of human challenge studies taking place across multiple infectious diseases, “as interest in these disease areas continues to grow.”
Last month, hVIVO announced that it had signed a £5.1m contract to test its Investigational Medicinal Product using its respiratory syncytial virus (RSV) Human Challenge Study Model.
The medical lab division is to conduct the study on behalf of its biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection. The study is due to commence in 2H22, with the revenue from the contract being recognised across 2021 and 2022, it noted.
RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties.
RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults. Among the elderly (aged 65+), RSV causes as many hospitalisations and deaths as influenza, according to The Centers for Disease Control and Prevention (CDC).
Open Orphan said RSV may lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.
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