WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Inclusion Criteria:

• Participants with IPF of any gender ≥ 40 years of age at time of signing theinformed consent.

• Able to understand the study and provide signed, written informed consent.

• Able to read and understand the language of the informed consent and othertrial-related materials.

• Meet the American Thoracic Society, European Respiratory Society, JapaneseRespiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.

• If a participant is on treatment with pirfenidone or nintedanib, the dose of themedication must be stable for ≥ 90 days prior to Screening with plans to maintainthe same dose throughout the study treatment period. Use of both agents together isnot permitted.

• If a participant was on treatment with nintedanib or pirfenidone, and the agent hasbeen discontinued, this must have occurred ≥ 30 days prior to Screening. AtScreening, there must also be no plan to start either of these medications for theduration of the study.

• FVC of ≥ 45 percent predicted (pp) at screening.

• DLCO of ≥ 25pp at screening.

• Willing and able to complete all protocol required study visits and procedures.

• All participants of childbearing potential must have a negative serum pregnancy testat Screening.

• Participants with reproductive potential must agree to use and follow medicallyapproved contraceptive precautions during the study

Exclusion Criteria:

• Acute exacerbation of IPF within 6 months of Screening or during the ScreeningPeriod.

• Forced expiratory volume in 1 second (FEV1)/FVC ratio of <0.7 at Screening.

• Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.

• Expected to receive a lung transplant within the study duration.

• Current active bacterial infection or use of antibiotics for suspected lunginfection in the 30 days prior to Screening.

• Planned surgery within the study duration.

• Clinically significant pulmonary hypertension.

• Use of immunosuppressive therapy (excluding corticosteroids). If previously on suchagents, they should have been discontinued for at least 5 half-lives or 90 days,whichever is longer, prior to Screening.

• Use of systemic corticosteroids (prednisone or equivalent) at a dose ≥ 10 mg oncedaily within 30 days of Screening.

• Currently smoking or vaping.

• Current known malignancy, or history of cancer, or lymphoproliferative disorderother than non-melanomatous skin cancers, within 2 years of Screening.

• Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

• Currently pregnant, breast feeding, or planning to conceive for the length of thestudy.

• History of severe depression, psychosis, or suicidal ideation, as determined by theInvestigator, within 2 years of Screening.

• Any clinically significant disease or laboratory abnormality detected at Screeningthat might interfere with a participant's ability to complete the study, on-studyevaluations, or participant safety.

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limitof normal (ULN) at Screening.

• Any other concurrent active medical condition determined by the Investigator tointerfere with participant's ability to complete the trial.

• Known allergy to MTX-463 or any of its excipients.

• Any prior use of MTX-463 or other therapy targeting WISP1.

• Any other concurrent experimental agent or an active part of any other clinicaltrial, unless they have stopped taking the investigational product at least 5half-lives or 30 days before Screening, whichever is longer.