Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy

The following contains proprietary/privileged information that Moonlight Therapeutics requests not be released to persons outside the government, except for purposes of review and evaluation Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within theSkin) patch for the Treatment of Peanut Allergy Food allergies affect 30 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there is only one FDA approved therapy in the USA for food allergies. Food allergies are expected to grow 10% annually until at least 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. Moonlight Therapeutics is developing a targeted way to administer allergens into the top skin layers to desensitize an allergic patient, called Targeted Allergen Specific Immunotherapy in the Skin (TASIS). Delivery is achieved using microneedles applied to the skin for a few minutes, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because TASIS delivers small doses in the top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. The company's first treatment is focused on peanut allergy and is called TASIS-Peanut. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. This Fast-track (Phase1/Phase2) SBIR grant (U44) application is for a Phase 1 safety and tolerability study to be conducted in partnership between the company and collaborating clinical research sites. The objective of the U44 Fast- track grant is to prepare documents for (grant PHASE 1) and conduct (grant PHASE 2) a Phase 1 clinical trial to assess the safety and tolerability of TASIS-Peanut in peanut allergic children and adults. The Phase 2 portion of the grant also includes aims geared towards production of TASIS-Peanut for the clinical trial. The company currently has a R42 Fast-track grant for the pre-clinical development of TASIS-Peanut. Overall this grant will enable evaluation of the safety and tolerability of TASIS-Peanut in a first-in-human clinical trial. It will set the stage for evaluation of efficacy in a Phase 2 clinical trial.