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 otherstudy-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, nintedanib, or nerandomilast, thedose of the medication must be stable for ≥ 90 days prior to Screening with plans tomaintain the same dose throughout the study. Use of any of these 3 agents incombination with each other is not permitted.

• If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast,and the agent has been discontinued, this must have occurred ≥ 30 days prior toScreening. At Screening, there must also be no plan to start either of thesemedications for the duration of the study. Participants newly diagnosed with IPFwho, in the judgment of the treating physician, are considered in need of treatmentwith nintedanib, pirfenidone, or nerandomilast should not defer standard of caretreatment and should be excluded from 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.

• Female participants of childbearing potential must have a negative serum pregnancytest at Screening.

• Participants with reproductive potential must agree to use and follow medicallyapproved highly effective methods of contraception during treatment and until 5half-lives or 125 days after the last dose of study drug, whichever is longer.

• Male participants with female partners of childbearing potential must use condomsduring the treatment and until 5 half-lives or 125 days after the last dose of studydrug, whichever is longer.

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.

• Presence of interstitial lung disease due to any cause other than IPF, clinicallysignificant cardiovascular disease, or any other concurrent active medical conditiondetermined by the Investigator to interfere with the participant's ability tocomplete the trial.

• Known allergy to MTX-463 or any of its excipients, or a history of a prior allergicreaction to a monoclonal antibody therapeutic.

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

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