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Details:
Avalyn will use the funds for the development of its portfolio of inhalation therapies for interstitial lung disease that improve upon currently approved medications, and advance lead clinical assets, AP01 (pirfenidone) and AP02 (nintedanib), into mid-stage clinical trials.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP01
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avalyn Pharma
Deal Size: $175.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing September 27, 2023
Details:
AP01 (pirfenidone) is a small molecule shown to inhibit fibroblast differentiation and extracellular matrix (ECM) production. It is being investigated in adults with pulmonary fibrosis.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP01
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2023
Details:
AP02 (nintedanib) is an investigational drug in development for pulmonary fibrosis. It inhibits profibrotic mediators including platelet-derived growth factor, fibroblast growth factor and transforming growth factor (TGF)-β as well as VEGF, reducing fibroblast activity.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP02
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2023
Details:
AP01 was safe and well tolerated at both doses. Flu-like symptoms and GI adverse events most commonly attributed to oral pirfenidone were seen in less than 10% of patients treated with AP01.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP01
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021
Details:
Based on these results the data safety monitoring board recommended conversion of all low dose patients to the high dose during the optional 12 month extension which is ongoing. AP01 was safe and well tolerated at both doses.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP01
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
Proceeds from the Series B expand the Avalyn's pipeline and will support the launch of a Phase II/III trial of AP01 in chronic lung allograft dysfunction (CLAD).
Lead Product(s): Pirfenidone
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Norwest Venture Partners
Deal Size: $35.5 million Upfront Cash: Undisclosed
Deal Type: Series B Financing April 27, 2020
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