Innovative Influenza Therapeutic Candidate Could Fundamentally Improve Treatment and Prophylaxis

SAB Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation to SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk patients, including those who have antiviral resistant strains.

SAB-176 is being developed for several influenza indications.

The FDA's Breakthrough Therapy designation confirms that the multi-epitope targeting modality of SAB-176 has a clear differentiation vs. monoclonal antibodies (mAbs) that bind to a single epitope.

And SAB's treatment can sustain its efficacy over viral mutations and prevent or reduce the risk of emerging treatment-resistant influenza strains.

Virus evolution driven by vaccines or treatments is a serious challenge, and the use of therapeutics can create "escape mutants" or versions of a virus that have changed to escape pressure on virus survival driven by antiviral treatment, whether it is a small molecule or mAbs modality, wrote the company.

SAB recently announced that the FDA had granted Fast Track designation to SAB-176.

The company had also received FDA guidance and regulatory alignment on advancing SAB-176 into the next development phase by initiating a Phase 2b clinical trial.

"Influenza continues to pose considerable health concerns in the U.S. and globally. This Breakthrough Therapy designation signifies an important step forward in our fight against this disease," said Eddie Sullivan, Ph.D., co-founder, President & CEO of SAB Biotherapeutics, in a press release on April 18, 2023.

"We are proud that based on generated preclinical and clinical evidence, SAB-176 has received both Breakthrough and Fast Track designations, a combination rarely seen."

The FDA's Breakthrough Therapy designation process is designed to expedite the development and reviewing a medicine intended to treat a serious or life-threatening condition. Preliminary clinical evidence indicates that the drug may substantially improve over current therapies on a clinically significant endpoint(s).

Products that qualify for Breakthrough Therapy designation receive more benefits than Fast Track products.

Precision Vaccinations post influenza vaccines news for April 2023.