Moonlight Therapeutics completes pre-IND meeting with FDA

Moonlight Therapeutics Completes Pre-IND Meeting With FDA for MOON101 for Peanut Allergy

MOON101 is Moonlight’s lead program for treating peanut allergy using a dermal stamp

Moonlight Therapeutics, Inc., a biotechnology company developing targeted treatments for food allergies, announced today it successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of MOON101 for the treatment of peanut allergy. More specifically, Moonlight has received guidance from the FDA on a first-in-human clinical trial for MOON101 in peanut allergic children and adults.

MOON101 uses Moonlight’s proprietary targeted allergen immunotherapy platform, TASIS, to treat peanut allergies. TASIS involves the application of a small, minimally invasive skin stamp to target the delivery of allergens to the skin’s immune cells to desensitize someone suffering from a food allergy. The dermal stamp is designed for at home self-administration. It is applied for only a few minutes and then discarded. The approach has shown promising results in animal models of peanut and other allergies.

“The feedback from the FDA was encouraging and we will now prepare to submit our IND in order to evaluate the safety and tolerability of MOON101 in peanut allergic individuals,” said Samir Patel, Moonlight Therapeutics co-founder and CEO. “Our first trial will include both adults and children with peanut allergy.”

The successful completion of this interaction with the FDA is an important milestone that provides regulatory clarity on MOON101’s planned development program. Moonlight expects to submit the IND package for MOON101 to the FDA later this year.

“Peanut allergy is a growing unmet medical need and affects over 6 million individuals in the United States alone. Over 1.5 million of those affected are children, which creates an incredible burden on families,” said Dr. Brian Vickery, who is the Director of the Food Allergy Center at Emory and Children’s Healthcare of Atlanta. “As a result, there is a large demand from families for a safe, robust, and convenient treatment for peanut allergy.”

About Moonlight Therapeutics
Based in Atlanta, Ga., Moonlight Therapeutics is an early-stage biotechnology company developing targeted, allergen-specific immunotherapy treatments for food allergies. Food allergies are estimated to affect more than 30 million people in the United States. Moonlight has developed its proprietary platform, TASIS, to target the delivery of allergens to immune cells in the skin. TASIS can be used to deliver individual or combinations of allergens to treat multiple allergies. This technology was invented at Texas Tech University and is supported by the Georgia Research Alliance. To learn more, visit

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Moonlight’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Moonlight’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Moonlight undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Moonlight Therapeutics
Samir Patel, CEO

Read original article here