ARC will use the proceeds to fund the upcoming Phase 3 clinical trial of ARC's lead product, AR 101, a standardized, pharmaceutical-grade peanut protein formulation for treating peanut allergy via characterized oral desensitization immunotherapy (CODIT™). The company also plans to begin clinical trials for treatment of egg and milk allergies in the coming year.
In association with the financing, Jim Tananbaum, MD, CEO and managing director of Foresite Capital, and Stacey Seltzer, partner at Aisling Capital, have joined the ARC board of directors. Dr. Tananbaum founded Foresite Capital in 2011 to finance transformative healthcare companies. He was also founder and CEO of Theravance and GelTex Pharmaceuticals, in addition to leading investments in numerous other companies that became healthcare leaders. Ms. Seltzer, who joined Aisling Capital in 2008, previously held positions in business development, marketing and sales with Schering-Plough and Akceli and was a management consultant for McKinsey & Company.
"Food allergies are a real, growing problem and a space we've been following for a while. ARC is developing an extremely promising option that could provide an unprecedented solution for families and physicians managing the stresses of food allergy avoidance and the dangers of accidental exposure," said Dr. Tananbaum. "ARC is a great example of companies we finance: ARC has a solid management team with deep industry experience, a transformative product with strong Phase 2 data, and the potential to solve a real-world problem in a large market. We are excited to support ARC as it takes the final steps toward turning decades of research into products and therapies to help patients suffering from food allergies."
ARC recently completed a successful multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial to demonstrate the safety and efficacy of AR 101 for the treatment of peanut allergy in children and adults. The U.S. Food and Drug Administration (FDA) has granted AR 101 Fast Track designation as part of its program to facilitate and expedite the development and review of drugs designed to treat serious conditions and fill an unmet medical need.
"People living with food allergies, many of whom are children, are at risk of life-threatening reactions to common everyday foods. Specifically, about a million children in the United States are allergic to peanuts. We are dedicated to developing standardized products for desensitization so that people and families living with food allergies can gain peace of mind," said ARC CEO Stephen Dilly, MBBS, PhD. "This financing equips us to advance AR 101 through our planned Phase 3 clinical trial and the rigorous FDA approval process as well as to begin development of novel oral immunotherapy products for other food allergies. We are immensely grateful for the capabilities and backing of our financial, clinical, and academic partners who have helped us reach the gate to a pivotal clinical trial in the United States for our first product."
ARC completed a $17 million Series A financing in November 2013, led by Longitude Capital with support from Food Allergy Research & Education (FARE), the nation's leading nonprofit focused on food allergies, and other investors.
"We believe that ARC will make a dramatic difference in the lives of food allergy patients, and we're eager to see that happen," said Patrick Enright, managing director of Longitude Capital and a member of the ARC board of directors. "Avoidance and epinephrine are not enough. ARC's oral immunotherapy platform has the potential to introduce a margin of safety for millions of people managing food allergies, and thus reduce stress and improve their overall quality of life."
About Food Allergies
Food allergies represent an urgent and growing global unmet medical need. Approximately 15 million people in the United States and 17 million people in Europe have food allergies. Moreover, the prevalence of food allergies is increasing rapidly—in the United States, 1 in 25 children suffered from a food allergy a decade ago, compared to 1 in 13 today, and a projected 1 in 5 by 2020. For people living with food allergies, certain foods can cause severe allergic reactions, including potentially life-threatening anaphylaxis. There is no cure for food allergies. Currently, food-allergic patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. Thus, in addition to the unmet medical need, food allergies can impose a significant quality of life burden. For more information, please visitwww.foodallergy.org and www.niaid.nih.gov/topics/foodallergy.
About Allergen Research Corporation
Allergen Research Corporation (ARC), founded in 2011, develops treatments for food allergies using characterized oral desensitization immunotherapy (CODIT™), its proprietary approach to oral immunotherapy (OIT). CODIT combines standardized, pharmaceutical-grade food allergens with controlled up-dosing protocols to desensitize patients and increase the thresholds at which they could experience allergic reactions. ARC recently completed a successful Phase 2 study of its lead product, AR 101, a standardized, pharmaceutical-grade peanut protein formulation for the treatment of peanut allergy, one of the most common food allergies. ARC is also developing CODIT for other common food allergies, including egg and milk. For more information, please visit www.allergenresearch.com.