QR052107B Tablet was safe and well tolerated in healthy volunteers across all tested doses, with no taste related adverse event at the anticipated therapeutic doses Createrna initiated a clinical Phase 2 trial to study QR052107B Tablet at once-a-day (QD) dose in the treatment of refractory and unexplained chronic cough
WUHAN, China, Dec. 8, 2022 /PRNewswire/ — Createrna Science & Technology (“Createrna” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for diseases with high unmet medical need, today announced positive top-line results from the Phase 1 studies of QR052107B Tablet, its leading drug candidate for the treatment of refractory and unexplained chronic cough (RCC and UCC).
The Phase 1 studies of QR052107B Tablet, a highly selective P2X3 receptor antagonist, include a single ascending dose (SAD) study, a multiple ascending dose (MAD) study and a food effect (FE) study. A total of 94 healthy adult subjects participated in these studies (SAD n=56; MAD n=30; and FE n=8). The top-line data from the Phase 1 studies have demonstrated that QR052107B Tablet at a single dose of 25 mg to 800 mg and multiple daily doses of 25 mg to 400 mg up to 14 days was safe and well tolerated by the healthy volunteers. The pharmacokinetic (PK) profile supports once-a-day (QD) dosing regimen. No serious adverse event (SAE) was reported and no subject in QR052107B Tablet treatment group discontinued the studies. In the 94 healthy volunteers enrolled in the Phase 1 studies, no taste alteration adverse events (AE) were reported.
Based on these encouraging data, the Company has advanced the QR052107B Tablet program into a Phase 2 study to assess the efficacy and safety of QR052107B Tablet in UCC and RCC patients.
“The completion of this Phase 1 study is an important milestone for Createrna. There are huge unmet medical needs for patients with persistent chronic cough. We hope our QR052107B Tablet can bring real clinical benefit to these patients,” stated Dr. Yaning Wang, the Chief Executive Officer.
“We are very excited with the findings of the Phase 1 studies. The data provided evidence that QR052107B Tablet is safe and well tolerated,” said Dr. Jing Zhang, the Chief Medical Officer. “The favorable safety and PK profile of QR052107B Tablet, especially the absence of taste related AEs in Phase 1 studies, suggest this investigational drug is just what those chronic cough patients need. I look forward to seeing results from the Phase 2 study in chronic cough patients.”
QR052107B Tablet Clinical Phase 1 Studies
Data from the SAD study have shown that QR052107B tablet had a good safety and tolerability profile at doses from 25 mg to 800 mg. All AEs were mild in severity and no taste alteration adverse event was reported.
The results from the MAD study have shown that QR052107B tablet at doses of 100 and 400 mg QD for 14 days was safe and well tolerated. Only one subject in the placebo treatment group withdrew due to an AE.
No significant trends of mean changes in vital signs, electrocardiogram (ECG) and clinical laboratory values were observed in the Phase 1 studies.
The pharmacokinetic data from the SAD study have shown that QR052107B was rapidly and thoroughly absorbed after a single oral administration. Plasma half-life was approximately 55-70 hours in healthy volunteers. After multiple oral administrations of QR052107B Tablet, plasma concentration of QR052107B Tablet reached steady state in 3~5 days in anticipated therapeutic dose range, i.e., 100 to 400 mg. Plasma Tmax and half-life of QR052107B Tablet after multiple administrations were similar to those observed in the SAD study. Overall, the observed pharmacokinetic profile suggested a once daily dosing regimen is appropriate for the future studies.
The exposure of QR052107B Tablet was not affected by food. Therefore, QR052107B Tablet can be administrated with or without food.
QR052107B Tablet Clinical Phase 2 Study Design
Createrna has initiated a Phase 2 study of QR052107B Tablet to treat RCC and UCC in November 2022 with anticipated top-line results to be released in the 2Q of 2024. This is a multiple center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QR052107B Tablet at doses of 100 mg and 400 mg in the treatment of RCC and UCC. The study will enroll a total of 210 patients.
About Createrna Science & Technology
Createrna Science & Technology is a clinical-stage biopharmaceutical company developing novel therapeutics for diseases with high unmet medical need. Its pipeline covers cardiovascular, respiratory, autoimmune, inflammatory and renal diseases. Currently Createrna has multiple clinical stage programs including 2 programs in Phase 2 and 5 programs in Phase 1.
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