Onconic's P-CAB New Drug 'Jastaprajan' Selected as Cover Paper in International Journal

Onconic Therapeutics announced on the 3rd that the clinical results of 'Zastaprazan (development name JP-1366)', a novel potassium-competitive acid blocker (P-CAB) candidate drug for gastroesophageal reflux disease (GERD) under development, have been selected and published as the cover paper of the SCI-level international medical journal AP&T. AP&T is an internationally recognized academic journal with an impact factor of 9.542.

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The published paper is a joint study by Professor Seunghwan Lee of Seoul National University College of Medicine and others titled ‘Randomised clinical trial: safety, tolerability, pharmacodynamics and pharmacokinetics of zastaprazan (JP-1366), a novel potassium-competitive acid blocker, in healthy subjects.'

This study was a randomized, open-label, placebo- and active-controlled, single and multiple ascending dose Phase 1 clinical trial conducted on healthy Korean male subjects. For pharmacodynamic evaluation, intragastric hydrogen ion concentration (pH) and serum gastrin were measured, and for pharmacokinetic (PK) evaluation, a series of blood and urine samples were collected. Pharmacogenomic assessments were also performed to explore genetic variations that could affect pharmacodynamics and pharmacokinetics, along with safety and tolerability evaluations including liver toxicity.

The results showed that acid secretion inhibition increased with the dose escalation of zastaprazan. The percentage of time with gastric pH above 4 (% time pH >4) was higher for zastaprazan 20 mg (85.19%) and 40 mg (91.84%) compared to esomeprazole 40 mg (72.06%), a proton pump inhibitor (PPI) used as a positive control. Additionally, zastaprazan was rapidly absorbed within 2 hours and eliminated from the body with a half-life of 6 to 10 hours.

Pharmacogenomic analysis did not find genetic variations in drug-metabolizing enzymes, including CYP2C19 or drug transporters related to zastaprazan exposure. Safety and tolerability assessments also showed excellent tolerability without clinically significant changes.

Accordingly, the research team explained that zastaprazan was safe and well tolerated after single oral doses up to 60 mg and multiple oral doses up to 40 mg. It also demonstrated rapid and potent suppression of gastric acid secretion.

These research results provided the basis for setting the doses for clinical Phase 2 and Phase 3 trials of zastaprazan. Onconic Therapeutics received approval from the Ministry of Food and Drug Safety in December 2021 for the Phase 3 clinical trial of zastaprazan and is accelerating the Phase 3 trial aiming for commercialization next year.

An Onconic Therapeutics official stated, “Zastaprazan has recently been licensed out to a Chinese pharmaceutical company for approximately 170 billion KRW, recognizing its value as an innovative P-CAB candidate drug,” and added, “Being featured on the cover of AP&T further proves zastaprazan’s global competitiveness.”

This content was produced with the assistance of AI translation services.