Moonlight Therapeutics Receives Clinical Trial Grant to Evaluate MOON101 for Peanut Allergy

Moonlight Therapeutics, a biotechnology company, has received a multi-million dollar clinical trial grant from the National Institutes of Health to evaluate its treatment, MOON101, for peanut allergy in peanut allergic children and adults.

ATLANTA, GEORGIA (PRWEB) JULY 10, 2023

Moonlight Therapeutics, Inc., a biotechnology company developing an intracutaneous treatment for food allergy, announced it has received a multi-million dollar Fast-Track small business clinical trial grant to evaluate its treatment, MOON101, for peanut allergy in peanut allergic children and adults. The clinical trial grant was awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). Moonlight has already completed a pre-IND meeting with the FDA on the first-in-human clinical trial for MOON101.

Monlight Therapeutics logo

MOON101 uses Moonlight’s proprietary platform, a small, minimally invasive skin stamp, designed to break through the top-most layers of the skin barrier and deliver allergens to the skin’s immune cells in order 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 removed. The approach has shown promising results in animal models of peanut and other allergies; data from these studies have been published in peer-reviewed journals.

This grant is the second small business grant the company has received from NIAID to develop MOON101 for the treatment of peanut allergy, bringing the company’s total non-dilutive funding to over $5 million. “This clinical trial grant represents further scientific validation of the company’s promising technology to address a large unmet need in the treatment of peanut and other food allergies,” said Samir Patel, Moonlight Therapeutics co-founder and CEO. “We were awarded this grant through a highly competitive review and it represents the meaningful progress we have made in advancing MOON101 towards the clinic.”

The clinical trial will be conducted in conjunction with several leading food allergy centers and clinical investigators in the United States. “There are over 6 million individuals in the United States alone with a peanut allergy and with only one FDA-approved therapy, there is still a large unmet need for patients and their families,” said Dr. Brian Vickery, who is the Director of the Food Allergy Center at Emory and Children’s Healthcare of Atlanta and serves as the lead clinical investigator on this grant. Dr. Vickery has been an investigator in food allergy clinical trials conducted at several stages of development including registration trials. “Clinical data from this grant will allow us to evaluate the effects of MOON101 directly on peanut allergic patients.”

“This award provides validation for the scientific approach Moonlight is taking and will facilitate the company’s entry into clinical trials,” added Dr. James Baker MD who is the founding Director of the Mary H. Weiser Food Allergy Center at University of Michigan and a former CEO of Food Allergy Research and Education (FARE), the national food allergy foundation.

Moonlight will be raising private funds to complement this award in order to accelerate the collection of the clinical data and development of MOON101.

About Moonlight Therapeutics

Moonlight Therapeutics is an early-stage biotechnology company based in Atlanta, Georgia. Moonlight is developing an intracutaneous allergen-specific immunotherapy platform for treating for food allergies. Food allergies are estimated to affect more than 30 million people in the United States. Moonlight has developed its proprietary platform, to break through the skin barrier and deliver allergens to immune cells in the top layer of the skin. This platform 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  moonlighttx.com.

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.

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ALPHARETTA, Ga., May 21, 2026 (GLOBE NEWSWIRE) -- Micron Biomedical today announced the grand opening of its world-class manufacturing facility spanning more than 26,000 square feet in Alpharetta, Georgia. The opening marks the most advanced commercial-scale manufacturing site for Micron’s dissolvable vaccine and therapeutic technology in the world and positions the company for pivotal clinical trials that will accelerate the availability of needle-free vaccines and therapeutics that can be self-administered at home. “A significant body of evidence has shown that our dissolvable microarray technology is as effective as — or more effective than — conventionally injected medicines. Parents, patients, government officials, drug developers, public health leaders, and payers also prefer needle-free vaccines and therapeutics that are simpler and more cost-effective to transport and store,” said Steven Damon, CEO of Micron Biomedical . “Our novel technology requires equally innovative manufacturing equipment capable of scaling production, and this facility brings us one step closer to making that vision a reality.” Micron’s technology uses a dissolvable microarray “button” that is applied directly to the skin and, when pressed, painlessly delivers medications that dissolve in the uppermost layers of skin. The facility houses all of the equipment and manufacturing capabilities to design and produce Micron’s technology at scale including R&D facilities, wet labs, dry labs, storage and professional office spaces. Micron Biomedical’s grand opening ceremony was attended by business leaders, elected officials, investors, members of academia and other stakeholders. Representatives from the CDC were also in attendance as recently the CDC launched its first-ever clinical trial of a needle-free vaccine, evaluating a novel rotavirus vaccine, CC24, delivered via Micron Biomedical’s dissolvable microarray technology. The trial, at Emory University, builds on research, published in The Lancet, about self-administered seasonal influenza vaccine via Micron Biomedical’s dissolvable microarray technology, as well as studies across other disease indications, including measles and rubella . “Georgia is emerging as one of the country’s most important biotech manufacturing hubs, attracting talented scientists, engineers, business leaders and creating exciting economic and professional opportunities for our residents,” said Todd Jones, Georgia House Representative . “With its award winning first-in-the industry technology, Micron Biomedical is among the state’s leaders in simultaneously transforming the health of people around the world with never-before-possible access to medicine and vaccines - and in investing in the workforce of tomorrow with high paying jobs and growth opportunities." This year, published research reinforced consumer preference for microarray technology and Micron Biomedical was recognized as the number two most innovative company in its class by Fast Company for addressing global demand for simplified administration and distribution of vaccines and drugs. The scientific community support includes recent commentary in The Lancet which called Micron’s technology “game-changing in humanitarian settings.” Micron’s technology class has also been identified as the highest global priority innovation for overcoming immunization barriers in low- and middle-income countries by the Vaccine Innovation Prioritisation Strategy (VIPS) Alliance. “This milestone reflects the type of coordinated ecosystem growth outlined in Georgia Life Sciences’ recently released Roadmap for Georgia’s Life Sciences Sector — bringing together industry, startups, manufacturers, educators, investors, and policymakers to strengthen the state’s innovation and manufacturing capabilities,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences , who attended the ribbon cutting ceremony. “With this cutting-edge facility, Micron is helping advance Georgia’s position as a national leader in biotechnology, medical technology, and life sciences innovation while reinforcing the state’s role as a scale-up manufacturing hub for the Southeast.” “Ribbon cuttings are always special and momentous events, but this one is especially satisfying because it points to an infrastructure for pivotal clinical trials of technologies being studied at Emory that have the potential to save lives and reduce disease burden by expanding coverage and access to critical medications,” said Christina Rostad MD, pediatric infectious disease associate professor at Emory University and lead investigator of the CD244 trial who provided commentary remotely. “Our team at Emory University is excited to be a part of the celebration and look forward to continuing to explore the potential of Micron Biomedical’s dissolvable microarray vaccine technology.“ About Micron Biomedical Micron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology with a growing pipeline of needle-free versions of previously injectable-only medicines. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public entities including pharmaceutical and biotech companies, the Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance. For more information visit www.micronbiomedical.com . Press Contact Shira Derasmo M: +1-917-280-2497 E: pr@micronbiomedical.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31153de2-caed-4aa2-b291-ebeed2652b70 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d855a883-fb26-47ce-9831-8ef1e0b93f43 
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Georgia Life Sciences thanks Dr. Marty Makary for his service as Commissioner of the U.S. Food and Drug Administration during a period of significant change across the nation’s health and regulatory agencies.
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