1. Huge drug market for IPF
(1) High mortality: The total IPF patient population worldwide was 1.27 M in 2019. The five-year survival rate from the initial diagnosis of an Acute IPF is 18.4%, which is less than that of most cancers.
(2) Huge drug market: only two marketed drugs for IPF, Pirfenidone (PFD) and Nintedanib. PFD sold 1.19 billion in 2019 even though there is severe AE and limited efficacy.
(3) IPF patients need long-term and lifelong medication. However, both marketed drugs are just recommended as appropriate in China. The class I recommended drugs is still in an empty position.
2. Asset showed more potent fibrosis inhibition activities in vitro, and greater improvement in vivo than PFD.
3. Excellent anti-tumor effect in vivo.
(1) Asset showed much stronger INFα and TGF-β1 inhibitory activity and much less cell proliferation than PFD.
(2) Asset showed concentration-dependently inhibition of α-SMA and COL1A1 protein in LX-2 cells.
(3) Asset showed great improvement in the efficacy evaluation of fibrosis score and artery lesions, resulting in better efficacy with a 10-fold lower dose than that of PFD.
3. Improved PK, broad safety window, and lower risk in safety issues.
(1) Asset QD vs PFD TID T1/2 (po.) in Rat: Asset = 8.12 h vs PFD = 0.40 h
(2) Compared with the two marketed drugs, the asset showed a broader safety window with a lower risk of safety issues in the preclinical study.
4. Excellent phase 1 data.
(1) Absorbed quickly (Tmax= 2~3 h).
(2) Well-absorbed and the therapeutic dose is estimated at 200 mg, meeting once daily dosing QD.
(3) Good safety, few AEs, and all are mild, no SAEs and death cases reported.
1. Asset type: TNFα and TGF-β1 inhibition
2. Indication: Idiopathic Pulmonary Fibrosis (IPF)
3. Research phase: Phase 2
4. Characteristic: FDA ODD for IPF
5. Cooperation demands: License-out or co-development
6. Research progress：
(1) Phase 2 trial is ongoing in both China and US.
(2) Good safety and few AEs.
(3) Suit for QD, remains better clinical compliance.
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