rivasterat (CU06) / Curacle, Thea Laboratories - LARVOL DELTA

CU104, a novel barrier function enhancer, improves colitis via modulation of barrier function and immune cell recruitment. (PubMed, Front Immunol) - "Consistent with these findings, CU104 improved the functions of vascular and intestinal barriers and regulated immune cell recruitment during inflammation. Collectively, our findings demonstrate that CU104 can regulate actin dynamics and inflammatory signaling pathways, highlighting potential therapeutic targets for IBD."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • EZR • IL10 • RDX

Study of CU06-1004 in Patients With Daibetic Macular Edema (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Curacle Co., Ltd.

New P2 trial • Diabetic Macular Edema • Macular Edema • Ophthalmology

Commentary: CU06-1004 inhibits the progression of chronic colitis and colitis-associated colorectal cancer by suppressing inflammation. (PubMed, Front Pharmacol) - No abstract available

Journal • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology • Solid Tumor

Curacle announced on the 29th that it has signed a contract with global clinical trial contract research organization (CRO) ‘Syneos Health’ to conduct a phase 2b clinical trial of ‘Rivasterat (CU06)’, an oral diabetic macular edema (DME) treatment candidate. [Google translation] (HIT News) - "Meanwhile, the company plans to apply for an investigational new drug (IND) application for a phase 2b clinical trial for DME indication to the U.S. Food and Drug Administration (FDA) in the first half of next year."

Commercial • IND • New P2b trial • Diabetic Macular Edema

CU06-1004 inhibits the progression of chronic colitis and colitis-associated colorectal cancer by suppressing inflammation. (PubMed, Front Pharmacol) - "Our findings suggest that CU06-1004 inhibits inflammation-induced tumorigenesis by modulating the inflammatory response in the colon. Consequently, CU06-1004 could represent a promising therapeutic candidate for the prevention of colorectal cancer through modulation of inflammation."

Journal • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Solid Tumor • Ulcerative Colitis • CD177 • CTNNB1 • IL6 • MYC • TNFA

Curacle, Endothelial Dysfunction Blocker 'Rivasterat' Listed by WHO INN [Google translation] (HIT News) - "Curacle announced on the 26th that its vascular endothelial dysfunction blocker CU06, which it is developing, has been officially registered by the World Health Organization (WHO) under the International Nonproprietary Name (INN) 'Rivasterat'."

Commercial • Age-related Macular Degeneration • Diabetic Macular Edema

Curacle, Shareholder Allocation Paid-in Capital Increase Decision… Expected Value Increase Through Progress in R&D Development of Major Pipelines such as CU06 and CU71 [Google translation] (Hankyung) - "Curacle...held a board meeting on the 16th and decided to increase capital through a public offering of common stock after allocating a total of 28.6 billion won to shareholders. The number of shares to be issued is 7 million, which is approximately 50% of the current number of issued shares...Curacle plans to focus the funds secured through this paid-in capital increase on R&D costs and operating funds for its main pipelines. The main uses are: Clinical phase 2b for retinal disease treatment drug CU06, Clinical phase 1 for Alzheimer's disease treatment drug CU71, and R&D progress for main pipelines such as CU01, MT-101, and MT-103....CU06 is a first-in-class new drug candidate under development as an oral retinal disease treatment, and is preparing to apply for an IND (clinical trial plan) for a phase 2b clinical trial in the second half of this year."

Financing • New P2b trial • Alzheimer's Disease • Diabetic Nephropathy • Retinal Disorders

Curacle, Diabetic Macular Edema Drug 'CU06' FDA Type C Meeting Minutes Received [Google translation] (The Bio) - "Curacle, a company specializing in intractable vascular diseases, announced on the 21st that it has officially received the minutes of the Type C meeting for 'CU06' held with the U.S. Food and Drug Administration (FDA) last month....'Based on what was discussed at the meeting, we plan to finalize the clinical protocol and, after consultation with the FDA, apply for an IND (clinical trial plan) for phase 2b clinical trials.'"

FDA event • Diabetic Macular Edema

Curacle, securing sales base… “6 new clinical drugs only, focusing on commercialization results this year” [Google translation] (Nate) - "First, its representative pipeline, diabetic macular edema treatment 'CU06', completed a meeting with the US Food and Drug Administration (FDA) last month in preparation for phase 2b clinical trials. It plans to submit an IND (Investigational New Drug) for phase 2b clinical trials this year. It is currently in technology transfer discussions with multiple companies....Curacle's diabetic nephropathy treatment 'CU01' is expected to complete phase 2b clinical trials this month. Clinical results will be available within the first half of this year."

IND • P2b data • Trial completion date • Diabetic Macular Edema • Diabetic Nephropathy

Curacle, Daesung Pharmtech merger… “High correlation and growth potential” [Google translation] (Medipana) - "According to the public notice on the 6th, the merger will be conducted in the form of a small-scale merger through the issuance of new shares, and the merger date is May 14. In particular, through this merger, Curacle expects to further strengthen its financial soundness while also combining Daesung Pharmtech’s raw pharmaceutical ingredient expertise with Curacle’s R&D capabilities, thereby generating high synergy effects....Ophthalmology is an area where Curacle is developing its core pipelines, such as 'CU06 (oral treatment for retinal diseases)' and 'MT-103 (dual antibody for retinal diseases)', and this merger is expected to enable close collaboration by utilizing networks between new drug development and raw pharmaceutical ingredients businesses in the future."

M&A • Retinal Disorders

A new blocker of endothelial dysfunction ameliorates colitis independently of IL-10 by regulating both barrier function and the recruitment of immune cells (ECCO-IBD 2025) - "Mechanistically, CU104 inhibited the activation of nuclear factor kappa-light-chain-enhancer of activated B cell (NF-κB) and interferon regulatory factor (IRF), 5 as well as the ezrin/radixin/moesin (ERM) signaling pathways 6 in vitro and in vivo, which play critical roles in maintaining barrier integrity and regulating immune cell recruitment during inflammation by regulating actin dynamics. Conclusion Our findings suggest that CU104, a pseudo-sugar derivative of cholesterol that regulates actin dynamics and inflammatory signaling, could be a promising new treatment for CD along with UC."

Immune cell • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • EZR • IL10 • RDX

Curacle, Successful Completion of CU06 Type C Meeting with US FDA [Google translation] (Pharm News) - "Curacle....announced on the 11th that it successfully completed a Type C meeting to discuss the overall development strategy for CU06, an oral retinal disease treatment, with the U.S. Food and Drug Administration (FDA)....Curacle is the world's first oral retinal disease treatment to undergo phase 2b clinical trials for the indication of diabetic macular edema, and has applied for this meeting to confirm the FDA's latest development standards and requirements in a situation where there is no regulatory precedent for existing oral treatments."

FDA event • Diabetic Macular Edema • Ophthalmology • Retinal Disorders

Curacle presents positive phase 2a results for CU06 at Asia Retina Congress (Korea Biomedical Review) - P2a | N=60 | NCT05573100 | Sponsor: Curacle Co., Ltd. | "Curacle, a Korean company focused on refractory vascular diseases, said Wednesday that it presented the results of its phase 2a clinical trial of CU06 for diabetic macular edema (DME) at the 4th Asia Retina Congress, held alongside the 2024 Annual Meeting of the Korean Retina Society in Seoul....The trial showed improvements in best corrected visual acuity across all dosing groups (100, 200, and 300 mg). The 300 mg group, consisting of patients with relatively low vision, experienced a maximum improvement of 5.8 letters....Curacle plans to finalize its development strategy, including phase 2b and 3 trials, through a Type C meeting with the U.S. FDA in February next year."

FDA event • P2a data • Diabetic Macular Edema

Curacle "Cu06, Vascular Endothelial Dysfunction Blocker, Patent Approved in Europe" [Google translation] (HIT News) - "Curacle...announced on the 27th that its vascular endothelial dysfunction blocker 'CU06' has received approval for a crystal patent registration from the European Patent Office....CU06, currently under development by Curacle, is a vascular endothelial dysfunction blocker and a treatment for retinal vascular diseases (diabetic macular edema and wet macular degeneration)."

Patent • Age-related Macular Degeneration • Diabetic Macular Edema • Immunology • Ophthalmology

The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Curacle Co., Ltd. | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial completion date: Mar 2024 ➔ Jun 2023 | Trial primary completion date: Feb 2024 ➔ May 2023

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

First in human, phase 1 study of CU06-1004, an oral vascular leakage blocker for the treatment of diabetic macular edema (DME) (ARVO 2024) - "Ascending single and multiple doses of CU06 appeared to be safe and generally well tolerated by the subjects in this study. There was a substantial food effect on CU06 and its metabolites. CU06 is currently in phase 2a trial in the USA and top-line data from the trial are expected in the first half of 2024."

P1 data • Diabetic Macular Edema • Ophthalmology • Retinal Disorders

Curacle receives US phase 2a clinical trial results report (CSR) for diabetic macular edema treatment ‘CU06’ [Google translation] (Pharm News) - P2a | N=60 | NCT05573100 | Sponsor: Curacle Co., Ltd. | "Curacle...announced on the 4th that it has received the final clinical trial results report (CSR) of the US phase 2a clinical trial for 'CU06', an oral diabetic macular edema treatment. revealed....In the 16th week results of a group of patients with relatively low visual acuity (normal visual acuity 0.5 or less) with a best-corrected visual acuity of 69 letters or less, the best-corrected visual acuity score was found to have increased, and the central macular thickness was maintained at the 12-week level. In particular, among the patient group (maximum corrected visual acuity of 69 letters or less), the 300 mg group, which showed an improvement of 5.8 letters at week 12, improved by 6.6 letters at week 16, an improvement of 0.8 letters more than the score reported in the topline announcement last February. showed."

FDA event • P2a data • Diabetic Macular Edema

Curacle, CU104, ulcerative colitis treatment phase 2 clinical trial approved by Ministry of Food and Drug Safety [Google translation] (Hankyung) - "Curacle announced...that it has submitted a phase 2 IND (clinical trial plan) for 'CU104', which is being developed as a treatment for ulcerative colitis, to the Ministry of Food and Drug Safety....The company announced that it plans to begin multinational clinical trials within this year after receiving IND approval in Korea....Meanwhile, Curacle announced in a public announcement on the same day that it voluntarily withdrew the high-dose phase 1b clinical trial IND that it had applied to the Ministry of Food and Drug Safety last year. The company explained that the reason for voluntarily withdrawing from the high-dose phase 1b clinical trial was due to the new formulation development schedule."

New P2 trial • Non-US regulatory • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CU06-1004 alleviates oxidative stress and inflammation on folic acid-induced acute kidney injury in mice. (PubMed, J Pharmacol Sci) - "These findings suggest CU06-1004 as a potential therapeutic agent for folic acid-induced AKI."

Journal • Preclinical • Acute Kidney Injury • Fibrosis • Immunology • Inflammation • Nephrology • Oncology • Renal Disease • ICAM1 • KIM1 • LCN2 • TNFA

CU06-1004 as a promising strategy to improve anti-cancer drug efficacy by preventing vascular leaky syndrome. (PubMed, Front Pharmacol) - "Notably, the HDIL-2 and CU06-1004 combination therapy considerably reduced tumor growth in the B16F10 melanoma mouse model. Our data suggest that CU06-1004 acts as a potential anticancer drug candidate, not only by preventing HDIL-2-induced VLS but also by enhancing the anticancer effects of HDIL-2 immunotherapy."

Journal • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Curacle applies for phase 1b domestic clinical trial for high-dose treatment for ulcerative colitis [Google translation] (HIT News) - "Curacle...submitted a high-dose phase 1b clinical trial (IND) to the Ministry of Food and Drug Safety to increase flexibility in selecting clinical doses for candidate substances for combination treatment of ulcerative colitis and immunotherapy....Through the high-dose phase 1b clinical trial, Curacle has established a safety range in advance so that the administration dose can be set flexibly in subsequent clinical trials such as phase 2b clinical trial for 'CU104 (ulcerative colitis)'..."

New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2a | N=60 | Active, not recruiting | Sponsor: Curacle Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology • IL1B • IL6 • TNFA

Curacle, Ulcerative Colitis Treatment Clinical Phase 2 IND European Submission (HIT News) - "Curacle...has submitted a phase 2 clinical trial plan (IND) for a new drug candidate for ulcerative colitis treatment, 'CU104 (development code name)' to each drug regulatory authority in three Eastern European countries 17 day was announced....The company explained that it submitted an IND after sufficient prior discussions with drug regulatory authorities in Bosnia, Serbia, and Macedonia in Eastern Europe."

New P2 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UC: Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Curacle Co., Ltd.

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: Curacle Co., Ltd. | Trial completion date: Jul 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology • IL1B • IL6 • TNFA