Scout Bio Initiates Multi-Center Clinical Study of Gene Therapy for Chronic Arthritis Pain In Cats

– First vectorized antibody gene therapy to be studied in pets

– Strong initial in-species data support therapeutic profile of one-time gene therapy designed for long-term pain management

– Novel monthly pain management antibody therapy also assessed as part of study design

– Topline data expected in Q3 2022

PHILADELPHIA, October 28, 2021 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions, today announced the initiation of a clinical study to evaluate the safety and efficacy of SB-007, the company’s one-time AAV gene therapy for chronic arthritis pain in cats. After a single injection, SB-007 is designed to trigger consistent long-term production of an antibody that inhibits a pain-promoting protein called nerve growth factor (NGF) in cats. The study will also assess SB-011, which is the anti-NGF antibody encoded by SB-007, in parallel development as a monthly injection.

“Pet owners and veterinarians are looking for ways to relieve chronic pain and restore quality of life in the most convenient, long-lasting way, which is the promise of one-time gene therapies like SB-007,” said Mark Heffernan, Ph.D., Chief Executive Officer of Scout Bio. “Emerging anti-NGF antibody therapies have validated the potential of this approach, and as the leaders in pet gene therapy Scout Bio has a clear opportunity to significantly improve treatment options in this major therapeutic area, as we are also doing in anemia, diabetes and atopic dermatitis.”

The study is a multi-center placebo-controlled pilot clinical study that will target enrollment of 132 client-owned (pet) cats in veterinary clinics throughout the United States. The study will include an evaluation of the SB-011 antibody given monthly; or two combination groups where one dose of SB-011 is followed two weeks later by one of two dosages of the SB-007 gene therapy. The transition enables the direct assessment of anti-NGF activity and clinical outcomes delivered by a monthly antibody versus a one-time gene therapy. Endpoints will include validated owner-assessment tools for pain and mobility in cats. Topline data from the study is expected in the third quarter of 2022.

Both SB-007 and SB-011 target feline NGF which has been shown to play an important role in the production of pain signals and inflammation in diseases like degenerative joint disease (DJD). Inhibition of NGF is intended to dramatically reduce or eliminate pain, improving a cat’s quality of life and mobility.

“Our anti-NGF candidates represent another major innovation to emerge from our proprietary research and AAV development platform. This study expands our work in vectorized antibodies, a gene therapy approach that allows patients to produce their own therapeutic antibodies after a single, intramuscular dose of gene therapy,” said Matt Wilson, Scout Bio’s VP of Product Discovery and External Innovation. “Anti-NGF antibodies are only the first of many antibodies that may be vectorized through a design process where we have specialist expertise based on our foundational partnership with the University of Pennsylvania’s Gene Therapy Program. In addition to feline anti-NGF vectorized antibodies, we are also advancing a canine anti-NGF and an anti-IL-31 antibody program for the major area of atopic dermatitis.”

Data highlights from completed studies of SB-011 and SB-007 to-date include:

• SB-011: This monoclonal antibody (mAb) candidate has demonstrated potent neutralizing activity and repeat dosing in healthy cats has been shown to achieve a serum concentration with potential for therapeutic effect. SB-011 has also demonstrated favorable safety following multiple repeated subcutaneous injections. No immunogenicity has been observed.
• SB-007: Our gene therapy program to express our SB-011 monoclonal antibody has demonstrated the ability to produce sustained plasma levels of the monoclonal antibody within a target therapeutic concentration for over a year after a single injection. The animals in this pre-clinical study continue to be followed long-term.
• No drug related adverse events have been observed with either product.

About Feline Chronic Pain and Degenerative Joint Disease (DJD)
Degenerative joint disease, also known as osteoarthritis or degenerative arthritis, is one of the most significant and under-diagnosed diseases of cats. It involves the destruction of cartilage and supportive tissue which causes pain. 90% of cats over age 12 have radiographic evidence of joint disease. It is difficult for owners to recognize clinical symptoms of arthritis in a cat, as they often conceal their pain. Nearly 40% of all cats have clinical signs of DJD which are often mistaken for normal signs of aging. They include limping, difficulty with stairs, stiffness upon rising, pain when petted, and inability to jump.

Veterinarians spend considerable time educating their clients about chronic diseases such as DJD. Clients and patients – particularly cats – struggle with the need for regular treatments to manage chronic disease or pain. A pet’s limited ability to clearly communicate when they are experiencing early symptoms of their chronic conditions can prevent early intervention. These factors often result in both poor compliance and patient outcomes for chronic diseases. Scout Bio’s proprietary market data strongly supports the eagerness of veterinarians for one-time therapies that can effectively answer these challenges.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s 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 Pennsylvania’s 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, see www.scoutbio.co.

For further information, please contact:

Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co