KOKUA PHARMA
About Kokua Pharma
From Bedside to Bench. And Back.
Kokua Pharma was founded on four decades of clinical observation in anaphylaxis treatment. These bedside observations drove engineering solutions, which were then translated back to the bedside. Our first product is KP001 (REZQPUFF), an inhaled epinephrine product for the emergency treatment of anaphylaxis.
The name Kokua is Hawaiian for "to work together for a common good." It reflects how we develop: clinicians identifying real problems, engineers designing solutions, and research institutions providing the science to connect the two.
Scientific Rationale
Why Inhaled Delivery?
Anaphylaxis Escalates Within Minutes
Histamine release begins within two minutes of allergen exposure. In preclinical models, delayed epinephrine treatment at 10 minutes resulted in 4x higher mortality compared to treatment at 5 minutes.*
Drug Delivered Where It's Needed Most
KP001 (REZQPUFF) is designed to deliver epinephrine to both the larynx and the deep lung, addressing upper airway edema locally while enabling rapid systemic absorption through the lung's extensive vascular surface.
Inhaled Delivery
Designed for pulmonary absorption and direct airway delivery
Needle-Free
Metered dose inhaler format
Preservative-Free Formulation
Being developed without sulfite preservatives
Clinical Evidence
Early Clinical Findings
In a proof-of-concept study presented at AAAAI 2026, 21 of 21 patients with moderate-to-severe allergic reactions (WAO Grade 2–5) experienced symptom resolution after treatment with a novel inhaled epinephrine. The average time to resolution was 3.5 minutes, with 48% of patients resolving after a single dose. No intramuscular epinephrine rescue was required, and no serious adverse events or biphasic reactions were reported.1
3.5 min
Average time to symptom resolution
21 of 21
Patients with symptom resolution
Zero
Patients needed IM epinephrine rescue
In a separate randomized, double-blind, placebo-controlled Phase 1 study also presented at AAAAI 2026, KP001 demonstrated a median Tmax of approximately 2 minutes at the low dose (0.25 mg) in healthy volunteers. KP001 showed an excellent safety profile consistent with the known pharmacologic effects of epinephrine.2
REZQPUFF is investigational and not yet FDA-approved. Preliminary findings from early-stage studies. Results may not be predictive of outcomes in larger controlled trials.
Pipeline
Development Pathway
505(b)(2) Regulatory Pathway
✓
Preclinical
Complete
◐
Phase 1
In Progress
○
NDA Filing
Studies Completed
✓ Investigator-Led Clinical Studies
Proof-of-concept in patients with allergic reactions (n=21)
✓ Phase 1 PK Study
Pharmacokinetic characterization in healthy volunteers
The 505(b)(2) pathway allows sponsors to reference FDA's existing safety and efficacy findings for approved drugs. The specific studies required between Phase 1 and NDA filing will be determined in consultation with FDA (feedback pending).
Leadership
Proven Inhaled Drug Development Expertise
Our team combines extensive capital markets experience with deep expertise in inhaled drug development and clinical operations.
GL
George H. Luciuk, MD
Founder
Allergist, former President of Allergy Section, Canadian Pediatric Society
KS
Kevin Stapleton, PhD
CMC & Development
FDA-approved inhaled products for CF, migraine, Parkinson's
LD
Lisa Discepola, MSc
Clinical Operations
Phase 1 to approval in asthma, allergy, autoimmune
SP
Simon Pimstone, MD, PhD
Clinical Development
Raised >$1B in capital markets, led public biotech companies
- Luciuk GH, Discepola L, Pimstone S, Stapleton KW. Time to Symptom Resolution: An Efficacy Endpoint for the Effectiveness of Anaphylaxis Treatments. J Allergy Clin Immunol. 2026;157(2 Suppl):Abstract 597.
- Luciuk GH, Discepola L, Pimstone S, Stapleton KW. The Pharmacokinetics of a Novel Inhaled Epinephrine. J Allergy Clin Immunol. 2026;157(2 Suppl):Abstract L80.
Business Development