Ukko, Inc. has announced that the first participant has been dosed in a Phase 1/2a clinical study evaluating UKK-0018, an experimental treatment designed for peanut allergy. The first-in-human trial marks an important step in the company’s effort to develop a faster, more precise approach to protecting patients from peanut-induced allergic reactions.
Current treatment options for peanut allergy often rely heavily on strict avoidance and emergency preparedness, placing a significant emotional and practical burden on patients and families. Uri Lopatin, MD, Chief Executive Officer of Ukko, emphasized the need for new therapeutic strategies. “Current approaches to peanut allergy remain burdensome and largely rely on strict avoidance, highlighting the significant unmet need for safer and more precise therapies that address the underlying immunological cause of disease,” he said.
Unlike traditional allergy shots or oral immunotherapy, UKK-0018 uses a computationally designed modified peanut protein delivered through messenger RNA (mRNA) and lipid nanoparticle (LNP) technology. After intramuscular injection, the body produces the modified peanut protein, which is intended to trigger protective B-cell and T-cell immune responses. Researchers hope the therapy may ultimately help protect patients against peanut-induced anaphylaxis with fewer treatments than existing approaches.
The Phase 1/2a study is enrolling 32 peanut-allergic adults at clinical sites in Australia and New Zealand. Investigators will primarily evaluate the safety and tolerability of ascending doses of UKK-0018 while also assessing early biological and clinical signals that could indicate therapeutic activity.
Grace Chen, MD, Chief Medical Officer of Ukko, said the company is encouraged by findings from its non-clinical research program. According to Chen, preclinical studies demonstrated “rapid and durable protective responses in anaphylaxis-prone animals,” including the generation of protective IgG antibodies and T-cell modulation. The current study will determine whether those findings can be replicated safely in human subjects.
Ukko believes its platform could eventually offer a more convenient treatment schedule than current approaches, which often require months or years of ongoing therapy. Lopatin noted that if successful, UKK-0018 “has the potential to benefit patients faster, more safely, and with fewer treatments as compared to current approaches.”
Initial safety and preliminary efficacy data from the study are expected to be presented at scientific meetings in early 2027. Beyond peanut allergy, Ukko says its computational protein design platform could eventually be applied to additional food allergens such as milk and tree nuts, as well as aeroallergens, potentially expanding the reach of precision-designed allergy therapies.
