★ Modality: Small molecule

★ Indications: Idiopathic Pulmonary Fibrosis (IPF)

★ Characteristic: FDA ODD for IPF

★ Research: Phase III.

★ Demands: License-out or co-development

1.Huge unmet clinical needs

Huge 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.

Highlights

Preclinical studies show：BetterPK, Broad safety window, and lower risk in safety issues.

Asset QD vs PFD TID T1/2 (po.) in Rat: Asset = 8.12 h vs PFD = 0.40 h

Summary of Phase II clinical trial

Good Efficacy: Asset demonstrated more pronounced effect on ΔFVC at 24 weeks than BI1015550, Pirfenidone, or Nintedanib.

Good Compliance: The positive drug Pirfenidone requires administration three times a day, with 2-3 tablets each time, totaling 1.2-1.8 grams.During the treatment process, the dosage needs to be adjusted to the maximum dose that the patient can tolerate. In contrast, Asset requires only one dose per day, with an estimated effective dose of 200 mg, demonstrating far better compliance than existing drugs.

Good Safety: The incidence of gastrointestinal reactions in the Asset group is similarto that in the Pirfenidone group, with only one case of rash and one case of photosensitivity reaction reported. Photosensitivity is a major adverse reaction of the positive drug Pirfenidone.