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FDA Grants Fast Track Designation to AV-001 for Moderate-to-Severe Acute Respiratory Distress Syndrome


Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation.

Damage lungs, severe respiratory illness, pneumonia, ARDS, acute respiratory distress syndrome caused by the coronavirus. Image Credit: Adobe Stock Images/Design Cells

Image Credit: Adobe Stock Images/Design Cells

Vasomune Therapeutics announced that the FDA has granted Fast Track designation to AV-001, an investigational drug in development to prevent or treat moderate-to-severe acute respiratory distress syndrome (ARDS) in patients with respiratory infections. According to the company, Phase I data demonstrated the safety and pharmacokinetic profile of AV-001, backing once-daily dosing. Additionally, the treatment showed support for strong Tie2 activation. AV-001 is currently recruiting patients for a Phase IIa trial as an ARDS treatment in pneumonia.1

“Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said Brian Jahns, PharmD, president, chief operating officer, Vasomune Therapeutics, in a press release. “Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical Research Programs award #PR191212 for support to advance AV-001 to the clinic and award #PR203503 for support to research AV-001 in Phase IIa. Vasomune is also grateful to the National Research Council of Canada Industrial Research Assistance Program for providing research and development funding which supported the Phase I study.”

In November 2023, AV-001 received a positive recommendation from an Independent Data and Safety Monitoring Board (IDSMB) for the AV-001-004 Phase IIa study.2 Earlier this month, the company presented a late-breaking scientific poster at the 2024 American Thoracic Society 2024 American Thoracic Society International Conference.3

“Peer-reviewed presentation of our Phase I development data is an important landmark in our development efforts for AV-001” said Jahns, in a press release. “Vasomune is grateful to the National Research Council Canada for grant #IRAP-965762 which supported the Phase I study. Vasomune is also indebted to the United States Department of Defense Congressionally Directed Medical Research Programs award #PR191212 for support to advance AV-001 into the clinic.”

According to Yale Medicine, 190,000 people in the United States are diagnosed with ARDS annually. It can be caused by conditions such as pneumonia, aspiration, bruising of the lungs, fat embolism, viral lung infections, and the inhalation of toxic substances. Sepsis and pneumonia make up anywhere from 40% to 60% of all ARDS cases. It also can occur as a result of COVID-19.

Currently, treatment for ARDS includes oxygen and ventilation for most patients, diuretics to help clear away excess fluid buildup, treatment for underlying causes, and having a patient lay on their stomach, which supports areas of the lung that aren’t used when lying on the back.4

“We know how to support people through ARDS very well,” says Lauren Ferrante, MD, MHS, pulmonary and critical care specialist, Yale Medicine, in an overview of ARDS. “But it’s still a serious problem. Even though we can support the body to give it time to recover, the lungs still have to start the recovery process themselves. There is no magic bullet treatment for ARDS.”4


1. Vasomune Therapeutics Receives US FDA Fast Track Designation for Novel Investigational Medicine AV-001. BusinessWire. May 28, 2024. Accessed May 28, 2024. https://www.businesswire.com/news/home/20240528034965/en/Vasomune-Therapeutics-Receives-US-FDA-Fast-Track-Designation-for-Novel-Investigational-Medicine-AV-001

2. Vasomune and AnGes Announce Drug Candidate AV-001 Receives Positive Recommendation from the IDSMB for AV001-004 Phase 2a Study. BusinessWire. November 14, 2023. Accessed May 28, 2024. https://www.businesswire.com/news/home/20231114795277/en/Vasomune-and-AnGes-Announce-Drug-Candidate-AV-001-Receives-Positive-Recommendation-from-the-IDSMB-for-AV001-004-Phase-2a-Study

3. Vasomune Therapeutics Announces Poster Presentation at the American Thoracic Society International Conference. BusinessWire. May 6, 2024. Accessed May 28, 2024. https://www.businesswire.com/news/home/20240506279014/en/Vasomune-Therapeutics-Announces-Poster-Presentation-at-the-American-Thoracic-Society-International-Conference

4. Acute Respiratory Distress Syndrome (ARDS). Yale Medicine. Accessed May 28, 2024. https://www.yalemedicine.org/conditions/ards

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