Leveraging State-of-the-Art Science to Break the Atopic March

Veterinary Medicinal Products Pipeline

EFD01B for Canine Atopic Dermatitis (CAD)

CAD is one of the most common canine skin diseases and a leading health concern, affecting 10 to 15% the US and European dog populations. Surveys show that over 60% of American households have pets and roughly half share the same bedroom. Clinical symptoms of CAD, e.g pruritus, can impact the quality of life for both dogs and their owners.

Our lead candidate, EFD01B, is a preparation of Bacillus Calmette-Guérin (BCG) inactivated using our EFD technology. It aims to prevent the clinical signs of CAD by restoring the capacity of the immune system to control allergic reactions through the induction of nonspecific CD4+CD25+FoxP3+ regulatory T cells.

EFD01B is expected to enter Target Animal Safety studies in 2019 before launching field safety and efficacy studies.

The U.S. Department of Agriculture (USDA) Centre for Veterinary Biologics (CVB) has confirmed that EFD01B will be regulated as a veterinary biological product. This will offer Tolerys the opportunity to file for a conditional license in parallel to field efficacy studies.

We also consider the development of EFD01B in other pet allergic diseases, including canine food allergy and feline asthma.

Human Medicinal Products Pipeline

EFD02 for human atopic dermatitis (AD)

AD is one of the most common and burdensome diseases of childhood usually appearing within the first 2 years of life and affecting up to 20% of children. It improves by adolescence in most cases but it often heralds the development of allergic rhinoconjunctivitis and/or asthma. AD is therefore called the first step of the 'Atopic March', which describes the typical progression of allergic diseases during childhood.

Tolerys's therapeutic approach aims to prevent and treat AD in the long-term through inducing tolerance to relevant allergens instead of limiting the severity of the clinical manifestations of the disease. Considering the early onset of the disease, the ability of EFD02 to safely and effectively treat pediatric AD in young children including those below 2 years of age is a major objective.

Human AD is the lead indication for EFD02 but we are also evaluating opportunities in allergic rhinoconjunctivitis and asthma.