SAB Biotherapeutics' SAB-176 Granted Breakthrough Therapy Designation by FDA for High-Risk Patients with Type A and B Influenza

SAB Biotherapeutics receives the FDA’s Breakthrough Therapy Designation for SAB-176, an investigational therapeutic for post-exposure prophylaxis of Type A and Type B influenza illness in high-risk patients. On April 13, SAB-176 received Fast Track designation from the FDA. SAB plans to move forward with a Phase 2b trial for efficacy and safety in high-risk patient populations, following FDA guidance and regulatory alignment.

Publish Date: 18-04-2023 Source: SAB Biotherapeutics

Influenza is a respiratory disease caused by influenza viruses belonging to genera influenzavirus A and B, with additionally known genera of influenzavirus C and D. Symptoms of influenza infection range from mild upper respiratory disease with fever, sore throat, runny nose, cough, headache, muscle pain, and fatigue to severe pneumonia caused by the virus or secondary bacterial infection of the lower respiratory tract. Influenza virus infection may also cause non-respiratory complications affecting other organ systems, including the heart and central nervous system. Young children and older adults are at increased risk for severe illness and infectious complications. Children who have not previously been exposed to influenza viruses are highly susceptible to infection and may have more severe symptoms with longer shedding periods of the virus.

According to estimates, the United States has faced a considerable burden of influenza, with around 9 million cases of flu, 4 million flu-related medical visits, 100,000 hospitalizations, and approximately 5,000 deaths.
Seasonal epidemics of influenza A and B viruses cause the majority of disease burden in humans, with most infections occurring in children and severe cases primarily affecting very young and elderly individuals.

However, the current Influenza treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (LBVD, Adjuvanted QIV, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Influenza treatment. The key companies in the advanced development stage are LG Chem, Seqirus, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Influenza to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.