Scout Bio Successfully Completes Pilot Clinical Study of SB-001, a Single-Injection AAV Gene Therapy – GlobeNewswire

PHILADELPHIA, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Scout Bio today announced the successful completion of a CKD-associated anemia study in client owned cats treated with SB-001, an AAV expressing feline erythropoietin (fEPO). The study demonstrated a prolonged therapeutic effect with statistically significant increases in red blood cells after a single injection. SB-001 is the first gene therapy to successfully treat feline patients with an acquired non-monogenic disease. These results pave the way for Scout Bios portfolio of AAV delivered therapeutic proteins for companion animal diseases.

Clinical Study Highlights:

In this study we have successfully shown that SB-001 has the ability to increase PCV into the normal range, thereby reducing or eliminating the clinical effects of anemia associated with CKD, said Mark Heffernan, Ph.D., CEO of Scout Bio. These exciting results reinforce the potential for Scout Bios gene therapy platform to advance treatments for other acquired chronic diseases such as diabetes, chronic pain and atopic dermatitis.

There are no FDA-approved treatments available for CKD-associated anemia in cats. The single injection treatment of SB-001 presents an enormous advantage in convenience, improved compliance, and potentially allows owners more quality time with their pets. A new option for cats with kidney disease and anemia is urgently needed. These cats come into the veterinary clinic with weakness, lethargy, breathing difficulties, and overall feeling very unwell. SB-001s ability to increase the PCV can make a huge difference for many of these cats that would otherwise face euthanasia, said Anne Traas, DVM, MS, DACT, Chief Development Officer for Scout Bio and head of the clinical team leading the study. It was very rewarding to hear from owners participating in the study who expressed their deep gratitude for the additional time SB-001 was able to provide their beloved pets.

James M. Wilson, MD, PhD, Director of the Gene Therapy Program at the University of Pennsylvaniaand a co-founder of Scout Bio, commented, Scout Bios focus in companion animals with chronic diseases has resulted in this successful demonstration that AAV gene therapy can be an effective alternative to frequent injections with therapeutic proteins and result in the improvement of feline patient lives. These results provide validation that Scout Bios platform can be used to successfully deliver therapeutic proteins to treat chronic diseases in companion animals.

Scout Bio intends to progress key manufacturing activities and safety studies that will be necessary to apply for Expanded Conditional Approval under FDA guidelines.

About SB-001 SB-001 has a unique and innovative adeno-associated viral (AAV) vector, containing the gene for feline EPO, for delivery into the muscle cell nucleus which will continually produce therapeutic levels of the hormone. The expressed feline EPO stimulates erythropoiesis, or red blood cell production. The U.S. Food and Drug Administration (FDA) CVM has confirmed that SB-001 is eligible for Expanded Conditional Approval, potentially shortening the time until this product could be approved and made available.

About Chronic Kidney Disease (CKD)-Associated AnemiaAnemia associated with chronic kidney disease (CKD) in cats is a disease of high unmet medical need, with no FDA-approved therapies currently available. CKD is one of the most common diseases in senior cats and is an end-of-life disease that creates quality of life issues for cats and their owners. Up to 21% of cats with CKD have anemia and the only currently available therapeutic options are multiple blood transfusions or repeated injections of off-label human drugs. Compared to the off-label use of human EPO drugs, SB-001 is expected to have a superior safety profile with respect to immune reactions and incidence of pure red cell aplasia (PRCA), a serious life-threatening condition.

About Scout BioScout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bios therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvanias Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, seewww.scoutbio.co

University of Pennsylvania Financial DisclosureDr. Wilson is a Penn faculty member, scientific collaborator, key advisor, and co-founder of Scout Bio. As such, he holds an equity stake in the Company, his laboratory at Penn receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional future financial benefits under licenses granted by Penn to Scout Bio. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

For further information, please contact:Fran GaconnierScout Bio214.417.4142 Fran.gaconnier@scoutbio.co

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Scout Bio Successfully Completes Pilot Clinical Study of SB-001, a Single-Injection AAV Gene Therapy - GlobeNewswire