Curacle announced on the 26th that it has confirmed the efficacy and safety of the top-line results of the phase 2a clinical trial for diabetic nephropathy CU01-1001, and that it has confirmed superior treatment effects compared to the placebo group in multiple evaluation indicators related to diabetic nephropathy.
This clinical trial was conducted at five hospitals including Yeungnam University Hospital. Recruiting 42 patients with type 2 diabetic nephropathy with albuminuria, maintaining the existing diabetes treatment (ACE inhibitor or ARB), and administering test drug CU01-1001 or placebo orally twice a day for 12 weeks for pharmacokinetic analysis and Efficacy and safety were evaluated.
As a result of statistical analysis, a significant increase in the estimated Glomerular Filtration Rate (eGFR) was observed in the CU01-1001 administration group (from 60.60mL/min/1.73㎡ to 64.40 mL/min/1.73㎡, change of 3.80 mL/min/1.73㎡) ㎡). The most frequent adverse reactions were flushing (including facial flushing) and nausea in 18.18% and 13.64%, respectively, and no serious adverse drug reactions were observed, confirming the safety and tolerability of CU01-1001.
“The glomerular filtration rate of patients with type 2 diabetic nephropathy decreases by an average of 2.42mL/min/1.73㎡ annually in Korea,” said Prof. As an increase of 1.73㎡ was observed, this drug is expected to become a new treatment option for patients with type 2 diabetic nephropathy in the future.”
“The SGLT-2 inhibitor, which has been in the spotlight recently, has shown positive results of clinical trials for cardiovascular and renal function. However, in patients with chronic disease for more than 10 years, kidney function due to renal fibrosis is very weakened and chronic kidney function,” said Kim Myung-hwa, CEO of Curacle. “The decline is deeply related to kidney fibrosis.”
He continued, “There is no oral renal fibrosis inhibitor currently on the market. CU01-1001 is a drug that has a clear differentiation from SGLT-2 inhibitors because its direct renal fibrosis inhibitory effect has been verified in animal experiments. CU01-1001 is Nrf2. It is an innovative drug with a new mechanism of action that can treat kidney fibrosis while activating TGF-β/Smad at the same time. “Drug Repositioning) is rapidly developing.”
Curacle Ji-Hye Kang, head of the clinical development division, said, “In this 2a clinical trial, CU01-1001 showed a significant improvement in the glomerular filtration rate and improvement in proteinuria symptoms that were clinically significant. “We plan to publish this result in international conferences and journals, and we are preparing for a later clinical trial with CRO D.T.&Sanomedix, which conducted the 2a test, to verify additional safety and to prove the effect of renal function recovery,” he said.
On the other hand, Curacle is expected to accelerate the phase 1 clinical trial in the US from April after receiving IND approval for the new oral diabetic macular edema drug CU06-1004 from the US Food and Drug Administration (FDA) on February 26th.