An Open-Label Extension Study of Subjects who Received an Avalyn Inhaled Antifibrotic Agent

You may be able to join if

• Provide written informed consent per the Institutional Review Board/Ethics Committee (IRB/EC)
• Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either IPF or PPF and with the approval of the Investigator. IPF is defined as: A specific form of chronic fibrosing interstitial pneumonia limited to the lung and associated with the pathological pattern of usual interstitial pneumonia (American Thoracic Society 2000; Raghu et al, 2018).  PPF is defined as: At least 2 of 3 criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation in a patient with an interstitial lung disease other than IPF (Raghu et al, 2022).  Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).
• Male subjects and female subjects of childbearing potential (FOCBP) (defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period. Male subjects must use a condom and female partners of male subjects who are of childbearing potential must use a highly effective method of contraception, defined below: a. A highly effective method of contraception is one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly. The acceptable methods of contraception include: i. sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. ii. a vasectomized partner iii. bilateral tubal occlusion iv. any effective intrauterine device/hormone-releasing system, and progesterone-only (oral, injectable, or implantable) or combined (estrogen- and progesterone-containing; oral, intravaginal, or transdermal) hormonal contraception associated with inhibition of ovulation. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. b. The efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea or other conditions where the drug absorption may be reduced. Advise women taking oral hormonal contraceptives experiencing these conditions to use alternative highly effective contraception. Note: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In the absence of 12 months of amenorrhea, a single folliclestimulating hormone measurement is insufficient to document menopause.
• Willingness to comply with all study visits and requirements.
• Male or female at least 18 years of age at Screening/Baseline (Day 1).