About Kokua Pharma

The story behind KP001 (REZQPUFF)

The Kokua Story

Dr. George H. Luciuk, Founder of Kokua Pharma

George H. Luciuk, MD

Founder

Kokua Pharma was founded on a clinical observation that most physicians would have missed.

Beginning in the early 1980s, Dr. George Luciuk noticed a troubling pattern in his allergy and immunology practice. A subset of patients experiencing severe allergic reactions were not improving after receiving standard epinephrine treatment. Some actually worsened, and many refused further doses, leaving their physicians with limited options during a medical emergency.

These patients were predominantly female, and further questioning revealed a constellation of seemingly unrelated symptoms: severe reactions to cosmetics, intolerance to wines and beers, and adverse responses to dried fruits. Dr. Luciuk recognized the common thread. Sodium metabisulfite, a sulfite preservative used across all of these products, was also present in the epinephrine being used to treat them. The very medication intended to save their lives contained an ingredient they could not tolerate.

Treating these patients with sulfite-free epinephrine via metered dose inhaler produced dramatically better results than expected.

This observation raised a fundamental question: was the benefit coming from the absence of sulfite, from the inhaled route of delivery, or both? Pursuing the answer would require crossing the boundary from clinical practice into pharmaceutical development.

Kokua

Hawaiian: to work together for a common good

Kokua Pharma was founded to translate what clinicians see at the bedside into engineering solutions at the laboratory bench, and bring those solutions back to the patients who need them.

Competitive Landscape

Current FDA-approved epinephrine products for anaphylaxis self-treatment and KP001 (REZQPUFF) in clinical development.

Approach Route Status Published Tmax Key Characteristics
Current Standard of Care Intramuscular injection Market leader ~8 min Needle-based, established treatment
Recent Market Entrant Nasal spray FDA-approved 2024 ~30 min Mucosal absorption, needle-free
KP001 (REZQPUFF) Inhaled (pulmonary) Phase 1 ~2 min§ Pulmonary delivery, needle-free, preservative-free

Key characteristics describe product design attributes. Published Tmax values are reported from independent studies with different designs, populations, and dosing; direct comparison across studies is not appropriate. KP001 (REZQPUFF) is investigational and not yet FDA-approved.

† Cassale et al. J Allergy Clin Immunol. 2023;152(6):1587-1596. DOI

‡ FDA Briefing Document for neffy, May 23, 2023. FDA

§ Luciuk GH, et al. J Allergy Clin Immunol. 2026;157(2 Suppl):Abstract L80. AAAAI 2026. Reported for 0.25 mg dose. View Poster

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