Parand Darou Pharma  Parand Darou Pharma

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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 II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Avalyn Pharma

            Deal Size: $175.0 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing September 27, 2023

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            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 II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 11, 2023

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            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 I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2023

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            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 II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 24, 2021

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            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 II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 16, 2020

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            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 III Product 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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