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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:
ATYR1923 (efzofitimod) is a potential first-in-class, works by selectively modulating Neuropilin-2 (NRP2) to downregulate the innate and adaptive immune responses in uncontrolled inflammatory disease states to resolve inflammation and prevent subsequent fibrosis.
Lead Product(s): Efzofitimod,Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ATYR1923
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
BLD-0409 (cudetaxestat) was well tolerated and showed no reports of treatment-related serious adverse events, including when co-administered with either pirfenidone or nintedanib, in healthy volunteers.
Lead Product(s): Cudetaxestat,Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409
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 September 04, 2022
Details:
BLD-0409 (cudetaxestat), a non-competitive autotaxin inhibitor with direct anti-fibrotic activity and differentiating characteristics that is expected to enter a planned phase 2 clinical trial in patients with idiopathic pulmonary fibrosis.
Lead Product(s): Cudetaxestat,Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409
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 August 01, 2022
Details:
Pirfenidone, the first AB-rated (fully substitutable) equivalent to Genentech’s Esbriet®*, to treat patients with idiopathic pulmonary fibrosis, a progressive disease that causes irreversible lung scarring and makes it difficult to breathe.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Pirfenidone-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
U.S. FDA provides feedback necessary to proceed into a phase 2 proof of concept (PoC)/dose ranging study of cudetaxestat, an investigational non-competitive autotaxin inhibitor in patients with idiopathic pulmonary fibrosis (IPF).
Lead Product(s): Cudetaxestat,Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409
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 April 04, 2022
Details:
New data from a phase 1 drug-drug interaction clinical study of cudetaxestat, an investigational non-competitive autotaxin inhibitor co-administered with either of two approved drugs for IPF (pirfenidone and nintedanib) will be presented.
Lead Product(s): Cudetaxestat,Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biotech Acquisition Company
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
The trial, funded by the National Institute for Health Research (NIHR), found that pirfenidone could offer a viable treatment for heart failure with preserved ejection fraction.
Lead Product(s): Pirfenidone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Esbriet
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Manchester University NHS Foundation Trust
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2021
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:
Preclinical studies suggest pirfenidone can both reduce scar tissue formation and reduce existing scarring in the heart. Researchers enrolled patients with heart failure, an ejection fraction of 45% or higher and elevated natriuretic peptides (markers of fluid retention).
Lead Product(s): Pirfenidone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2021
Details:
US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Esbriet
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 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
Details:
Multiple ascending dose and food effect study will be a follow-up to a previously conducted single ascending dose clinical trial of LYT-100.
Lead Product(s): Pirfenidone
Therapeutic Area: Endocrinology Product Name: Undisclosed
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 03, 2020
Details:
The designation is based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks.
Lead Product(s): Pirfenidone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
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 March 03, 2020
Details:
The values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability.
Lead Product(s): Pirfenidone
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2020
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