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Your Position: Home > Licensing > BHE202204

NCE for the treatment of IPF

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  • Project profile
    Project name: NCE for the treatment of IPF
    Indications: Idiopathic Pulmonary Fibrosis (IPF)
    Research phase: Phase 2
    Cooperation demands: License-out or co-development
  • Highlights

    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.

  • Project Introduction

    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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