2023-08-29 04:11:53
Flexibility in follow-up clinical dose selection ↑ Maximizes the safety window
Possible positioning as a safer drug by widening the maximum margin of safety for candidates in the clinical trial stage
[바이오타임즈] Curacle (365270, CEO Jae-Hyeon Yoo), a company specializing in the development of new drugs for incurable vascular diseases, has developed a high-dose clinical trial phase 1b IND (clinical trial plan) to increase the flexibility in selecting clinical doses for ulcerative colitis treatment and immuno-anticancer drug candidate drugs for food and drug safety. It was announced through a public notice on the 29th that it had been submitted to the Ministry of Justice.
Curacle’s strategy is to maximize the safety range in advance through the high-dose phase 1b clinical trial so that the administration dose can be flexibly set in follow-up clinical trials, such as phase 2b clinical trials for CU104 (ulcerative colitis) and phase 2a clinical trials for CU106 (immunotherapy). am.
CU104 mediates endothelial cell homeostasis and blocks vascular abnormalities and inflammation induced by various vascular endothelial activators. It suppresses the levels of TNF-α, IL-1β, and IL-6 to reduce abnormal blood vessels and vascular barrier destruction, and upregulates the expression of junctional proteins (Occludin, ZO-1, and Claudin 5) to strengthen endothelial cell junctions.
In animal experiments, the CU106 pipeline showed the effect of normalizing blood vessels by maintaining stabilization of blood vessels and suppressing leakage when administered in combination with immunotherapeutic agents, and as a result, it showed the possibility of increasing the effect of immunotherapeutic agents.
For the global phase 2a clinical trial of CU104, Curacle submitted INDs to three European countries following receiving IND approval from the US FDA in July, and plans to start clinical trials following receiving IND approval in Korea. If the effect is proven in phase 2a for proof-of-concept (PoC), phase 2b will be conducted to find the optimal dosage and usage. It is expected that
In addition, Curacle is reviewing various immuno-anticancer drug candidates with several partners for the joint development of CU106, and it is expected that the increase in dose selectivity will give more momentum to finding the optimal combination among immuno-anticancer drugs in the future phase 2a clinical trial. am.
An official from Curacle explained, “It was judged that it would be possible to position the drug as a safer drug by widening the maximum safety margin of candidates in the clinical trial stage, such as CU104 and CU106, so we preemptively prepared for the high-dose phase 1b clinical trial.”
“CU06 (diabetic macular edema), which is undergoing phase 2a clinical trials in the US, is also the same substance as CU104 and CU106, so if a wide range of safe doses is secured through this phase 1b clinical trial, it will help medical staff and patients in the retinal disease market with many elderly patients. It is expected that it will be more useful for people.”
[바이오타임즈=정민구 기자] news@biotimes.co.kr
© Biotimes Unauthorized reproduction and redistribution prohibited
1693286561
#Curacle #applies #IND #highdose #phase #clinical #trials #including #ulcerative #colitis #treatment #immunoanticancer #drug #combination #therapy
