A Phase 1 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of AP02 (nintedanib solution for inhalation) delivered via the eFlow® Nebulizer System in healthy volunteers

Start Date24 Jul 2024

Sponsor / Collaborator

Avalyn Pharma, Inc.

NCT06329401

/ RecruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants with PPF

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Start Date03 Apr 2024

Sponsor / Collaborator

Avalyn Pharma, Inc.

[+1]

EUCTR2020-005103-39-CZ

/ Not yet recruitingPhase 2

Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis

Start Date16 Apr 2021

Sponsor / Collaborator

Avalyn Pharma, Inc.

100 Clinical Results associated with Avalyn Pharma, Inc.

0 Patents (Medical) associated with Avalyn Pharma, Inc.

Literatures (Medical) associated with Avalyn Pharma, Inc.

01 May 2024·B48. NEW TREATMENTS IN DIFFUSE PARENCHYMAL LUNG DISEASE

Safety and Efficacy of Inhaled Pirfenidone (AP01) in the Atlas Open-label Extension Study

Author: Nair, D. ; Corte, T.J. ; Woodhead, F.A. ; Bao, H. ; Lazarus, H.M. ; Wilsher, M.L.

01 May 2024·B48. NEW TREATMENTS IN DIFFUSE PARENCHYMAL LUNG DISEASE

Differences in E-lung Biomarker Scores Between Treatment Groups in Post-hoc Analysis of the ATLAS Inhaled Pirfenidone Solution (AP01) for IPF Clinical Trial

Author: Abou-Zeid, W. ; Gerry, S. ; Sifostratoudaki, A. ; Ottink, F. ; Rennison-Jones, C. ; Lazarus, H.M. ; George, P.M. ; Stewart, R. ; Devaraj, A. ; Woodhead, F.A. ; Harston, G. ; Fernandez, C. ; Nair, D. ; Joly, O.

01 Sep 2023·Thorax

Inhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose–response trial

Article

Author: Glaspole, Ian ; Veale, Antony ; Piotrowski, Wojciech ; Hopkins, Peter ; Wilsher, Margaret L ; Raghu, Ganesh ; Shaffer, Michele L ; Wijsenbeek, Marlies S ; Barczyk, Adam ; Chaudhuri, Nazia ; Jassem, Ewa ; Šterclová, Martina ; Grainge, Christopher ; Montgomery, A Bruce ; Freeman, Lisa ; West, Alex ; Nair, Deepthi ; Corte, Tamera Jo ; Otto, Kelly

IntroductionOral pirfenidone reduces lung function decline and mortality in patients with idiopathic pulmonary fibrosis (IPF). Systemic exposure can have significant side effects, including nausea, rash, photosensitivity, weight loss and fatigue. Reduced doses may be suboptimal in slowing disease progression.MethodsThis phase 1b, randomised, open-label, dose–response trial at 25 sites in six countries (Australian New Zealand Clinical Trials Registry (ANZCTR) registration number ACTRN12618001838202) assessed safety, tolerability and efficacy of inhaled pirfenidone (AP01) in IPF. Patients diagnosed within 5 years, with forced vital capacity (FVC) 40%–90% predicted, and intolerant, unwilling or ineligible for oral pirfenidone or nintedanib were randomly assigned 1:1 to nebulised AP01 50 mg once per day or 100 mg two times per day for up to 72 weeks.ResultsWe present results for week 24, the primary endpoint and week 48 for comparability with published trials of antifibrotics. Week 72 data will be reported as a separate analysis pooled with the ongoing open-label extension study. Ninety-one patients (50 mg once per day: n=46, 100 mg two times per day: n=45) were enrolled from May 2019 to April 2020. The most common treatment-related adverse events (frequency, % of patients) were all mild or moderate and included cough (14, 15.4%), rash (11, 12.1%), nausea (8, 8.8%), throat irritation (5, 5.5%), fatigue (4, 4.4%) and taste disorder, dizziness and dyspnoea (three each, 3.3%). Changes in FVC % predicted over 24 and 48 weeks, respectively, were −2.5 (95% CI −5.3 to 0.4, −88 mL) and −4.9 (−7.5 to −2.3,–188 mL) in the 50 mg once per day and 0.6 (−2.2 to 3.4, 10 mL) and −0.4 (−3.2 to 2.3, −34 mL) in the 100 mg two times per day group.DiscussionSide effects commonly associated with oral pirfenidone in other clinical trials were less frequent with AP01. Mean FVC % predicted remained stable in the 100 mg two times per day group. Further study of AP01 is warranted.Trial registration numberACTRN12618001838202 Australian New Zealand Clinical Trials Registry.

News (Medical) associated with Avalyn Pharma, Inc.

17 Dec 2024

·www.globenewswire.com

Avalyn to Present at the 43rd Annual J.P. Morgan Healthcare Conference

CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 3:00 p.m. PT in San Francisco. Ms. Baranowski, CEO; Douglas Carlson, CFO, CBO; Howard Lazarus, M.D., FCCP, CMO; and Melissa Rhodes, Ph.D., COO, will also participate in 1x1 meetings with investors. About Avalyn PharmaAvalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex StrausTHRUST Strategic Communicationsalex@thrustsc.comir@avalynpharma.com Media Contact:Marites CoulterDeerfield Groupmarites.coulter@deerfieldgroup.commedia@avalynpharma.com

Phase 2Phase 1

25 Nov 2024

·www.globenewswire.com

Avalyn to Participate in Multiple Upcoming Investor Conferences

CAMBRIDGE, Mass., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in December. 7th Annual Evercore HealthCONx Conference Format: Fireside Chat and 1x1 Meetings Date: Tuesday, December 3, 2024, at 3:50 p.m. ET Location: The Loews Coral Gables Hotel, Coral Gables, FL Participants: Lyn Baranowski, CEO; Douglas Carlson, CFO, CBO; Howard M. Lazarus, CMO Citi’s 2024 Global Healthcare Conference Format: Fireside Chat and 1x1 Meetings Date: Wednesday, December 4, 2024, at 11:00 a.m. ET Location: InterContinental Hotel, Miami, FL Participants: Lyn Baranowski, CEO; Douglas Carlson, CFO, CBO; Howard M. Lazarus, CMO About Avalyn PharmaAvalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex StrausTHRUST Strategic Communicationsalex@thrustsc.com ir@avalynpharma.com Media Contact:Marites CoulterDeerfield Groupmarites.coulter@deerfieldgroup.com media@avalynpharma.com

Phase 2Clinical ResultPhase 1

19 Nov 2024

·endpts.com

Bayer, Cytokinetics make a deal in Japan; Ex-Carmot CEO to run LB Pharmaceuticals

Plus, news about Spyre, Tongrui Biotech, ATB Therapeutics, Freya Biosciences, Intas and Xbrane: Bayer, Cytokinetics ink deal for heart drug in Japan: The German drugmaker is paying €50 million upfront, with an additional €90 million in milestones available through launch and up to €490 million in commercial milestones. Cytokinetics is developing aficamten for obstructive and non-obstructive hypertrophic cardiomyopathy. — Jaimy Lee Heather Turner’s new gigs: In addition to being named chair of Avalyn Pharma, she’s been tapped as CEO of LB Pharmaceuticals and a board director at Terns Pharmaceuticals. Back in June, Endpoints News reported that LB, a New York-based schizophrenia biotech, was considering an IPO after raising a $75 million Series C. Turner has experience with IPOs: She was CEO at Carmot Therapeutics when it announced plans to go public (although Roche ended up buying it) and legal chief at Lyell Immunopharma when it had its IPO in 2021. — Kyle LaHucik Spyre’s $200M offering: The Waltham, MA-based biotech is selling shares after releasing interim Phase 1 data in healthy volunteers for its inflammatory bowel disease drug last week. The company has done multiple financings since going public via a reverse merger last year, including inking $180 million in private placements in December and March. — Kyle LaHucik Tongrui raises more than $100M: The Chinese biotech, which is focused on radiopharmaceuticals, said the Series A was led by Shenzhen Capital Group and Tailong Investment. Other investors include Hillhouse Ventures and 3SBio. Tongrui was founded three years ago. — Jaimy Lee Belgian biotech raises €54M: ATB Therapeutics snagged the Series A from MRL Ventures Fund (Merck’s venture arm), EQT Life Sciences, V-Bio Ventures and others. The money is set to go toward biologics that entail “cell-killing mechanisms.” — Kyle LaHucik Freya gets $10.4M from the Gates Foundation: The women’s health company, which is developing microbial immunotherapies for bacterial vaginosis and preventing pre-term birth, has now raised about $50 million in its Series A. It also received $1.4 million from the Export and Investment Fund of Denmark. — Jaimy Lee Intas gets rights to Opdivo biosimilar candidate: Intas is paying €10 million upfront, with an additional €3 million in development milestones on the table. Xbrane is working on a biosimilar of Bristol Myers Squibb’s Opdivo, or nivolumab. Opdivo’s patent in the US is set to expire in four years. — Jaimy Lee

IPOPhase 1ImmunotherapyExecutive Change

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100 Translational Medicine associated with Avalyn Pharma, Inc.

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Pipeline Snapshot as of 17 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pirfenidone	Progressive fibrotic interstitial lung disease More	Phase 2
Pirfenidone/Nintedanib	Lung Diseases, Interstitial More	Preclinical
Imatinib mesylate ( ABL x Bcr-Abl x PDGFR x c-Kit )	Pulmonary Arterial Hypertension More	Discontinued
Nintedanib esylate ( CSF-1R x FGFRs x FLT3 x PDGFR x VEGFR )	Idiopathic Pulmonary Fibrosis More	Pending

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