Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).

Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form

2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines

3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation

4. Meeting all of the following criteria during the screening period:

   1. FVC ≥40% predicted normal
   2. DLCO corrected for Hgb ≥25% and <80% predicted normal
   3. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings