Moonlight Therapeutics, Inc., a biotechnology company developing a platform to treat food allergies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MOON101 to initiate its first clinical trial in individuals with peanut allergy. In addition, Moonlight has raised private funds to support clinical development of MOON101 and received a new grant from the U.S. Defense Health Agency (DHA)’s Congressionally Directed Medical Research Programs (CDMRP) to expand its pipeline beyond MOON101.
Last year, Moonlight raised its first equity round of $2.4 million in Seed funding from Portal Innovations, Allerfund, and Invest Georgia that would enabled the company to initiate its first clinical trial, SURVEYOR. The FDA clearance of the IND application for MOON101 will now enable the start of the SURVEYOR trial whose aim will be to evaluate the safety of MOON101 in peanut allergic adults and children. The trial will be funded through a $3 million cooperative grant from the National Institute of Allergy and Infectious Diseases and new private funding from SOSV, a global deep tech venture capital firm.
MOON101 will be evaluated in the clinic in peanut allergic individuals with the eventual goal of demonstrating that this therapy can modulate the immune system of a peanut allergic person away from anaphylactic reactions that can occur from even small amounts of exposure to peanuts.
“This FDA clearance marks a pivotal milestone for Moonlight and for families living with peanut allergy,” said Samir Patel, co-founder and CEO of Moonlight Therapeutics. “We are now positioned to move MOON101 into the clinic and evaluate its safety in peanut allergic individuals with the eventual goal of demonstrating that MOON101 can modulate the immune system of a peanut allergic person away from anaphylactic reactions that can occur from even small amounts of exposure to peanuts.”
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MOON101 uses Moonlight’s proprietary intradermal allergen immunotherapy platform to desensitize individuals with a food allergy. The platform delivers allergens directly into the skin using a small, minimally invasive dermal stamp. The treatment is designed for at-home self-administration that requires less than five minutes of wear time of the stamp and has shown promising results in preclinical studies of peanut allergies. The new grant from the DHA’s Congressionally Directed Medical Research Programs (CDMRP) will support the company’s broader pipeline development, enabling advancement of its proprietary intradermal allergen immunotherapy platform beyond MOON101.
The upcoming clinical trial will be conducted in collaboration with leading food allergy centers in the United States. “There are over six million people in the United States with a peanut allergy, but the vast majority of patients are not pursuing treatment and unmet need remains high,” said Dr. Brian Vickery, Chief, Division of Allergy/Immunology, Children’s Healthcare of Atlanta, Marcus Professor of Pediatric Immunology, Emory University School of Medicine and lead clinical investigator on the trial. “We are excited to begin testing the safety and tolerability of MOON101 in peanut-allergic individuals and evaluate its potential as a patient-friendly and convenient treatment option.”
“For too long, peanut allergy has been overlooked rather than recognized as a frontier of medicine,” said Stephen Chambers, General Partner at SOSV and Managing Director at startup development program IndieBio. “In reality, peanut-allergic individuals are overdue for the kind of innovation we’ve already unleashed in other immune-mediated diseases. This is exactly why SOSV invests: to back the science and founders in transforming overlooked populations into the next wave of breakthrough therapies.”
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Source – PR Web
