초록

DA-1241(DA-1240 back up 물질)전임상 평가가 마무리됨에 따라 임상 1상을 진행할 수 있는 안전역 확보 및 특허성 있는 골격으로 PCT 출원을 완료함에 임상 1상을 위한 준비는 마무리 되었으며 선도물질이 보여준 반복 약효에서의 약효 사라짐 및 제한적인 전임상에서의 약효를 모두 극복 및 개선함에 따라 DA-1241의 신규 기전으로서의 당뇨치료제 개발은 매우 긍정적이며 국제학회를 통하여 DA-1241에 보여준 Big pharm들의 관심과 공동 개발 의지는 글로벌 신약으로서의 성공 가능성이 높음을 예측할 수 있음

Abstract ▼

Ⅰ. Purpose and Needs for R&D
: Development of new diabetic target which satisfies the unmet needs of current anti-diabetic treatments.
: While there are no side effects with current anti-diabetic treatments, development of more effective cardiovascular disorders medication is still required.

Ⅰ. Purpose and Needs for R&D
: Development of new diabetic target which satisfies the unmet needs of current anti-diabetic treatments.
: While there are no side effects with current anti-diabetic treatments, development of more effective cardiovascular disorders medication is still required.

Ⅱ. Contents of R&D
: Selection of a clinical trial candidate as a safe GPR119 agonist.
: Finish toxicity tests and demonstrate the superiority of glucose lowering effectiveness compared to pre-existing GPR119 agonists.

Ⅲ. Result of R&D
: Result of toxicity package
(Rat NOAEL > 1000mpk , Dog NOAEL > 300mpk)
: Confirm the superiority of anti-diabetic efficacy
(potency > 3~5 times, efficacy > 1.5 times / no tachypyraxis / distinct effect protection of beta cell / improvement of lipid profile)
: Confirm synergy effectiveness of anti-diabetic treatment with DPP-4 inhibitor and Metformin

Ⅳ. Utilization plan of research result
: Based on preclinical results for meeting the international standard, domestic and international clinical study are planed.
: Looking for co-development partner for international development and preparing for the development of global blockbuster product