INFECTION RESEARCH UPDATE

Infection research remains a top priority for the Cystic Fibrosis Foundation. As we approach the new year, we are excited to report on all the latest news on studies either funded by the Foundation or facilitated through its clinical trial network, the Therapeutics Development Network.

Today, we announced that we invested $4.85 million in Aridis Pharmaceuticals to continue testing a non-traditional anti-infective that could help fight antibiotic-resistant bacteria. Aridis completed enrollment of its Phase 2a clinical trial in November and expects to report some data in the first quarter of 2023.

Two industry-led clinical trials to develop treatments for nontuberculous mycobacteria (NTM) infections in people with cystic fibrosis are either underway or in planning:

• Beyond Air reported positive safety, tolerability, and efficacy data in October from its LungFit GO pilot study of inhaled nitric oxide to treat NTM in people with CF.
• Matinas Biopharma plans to start a Phase 2 trial of oral amikacin to treat NTM in people with CF in 2023.

In other news, Idera Pharmaceuticals announced recently it will soon start a Phase 2 trial to test a potential treatment for pulmonary exacerbations in people with CF. Initial data are expected in the second half of 2023. (In September, Idera bought Aceragen Inc., the parent company of Arrevus Inc. In January, the Foundation awarded Arrevus $3.5 million to test this potential treatment).

Spotlight on Pseudomonas

Because of the prevalence of Pseudomonas aeruginosa in people with CF and the growth of multi-drug resistant strains, the Foundation is aggressively pursuing treatments for these bacteria. More than 28% of people with CF tested positive for Pseudomonas, according to the 2021 Patient Registry Annual Data Report.

Pseudomonas research projects compose almost 40% of our infection research portfolio with a third of that funding going toward developing new treatments. Since the launch of the Infection Research Initiative in 2018, eight new drug development programs targeting Pseudomonas infections have been funded, three of which use bacteriophage (phage) therapy. The latest updates on phage programs that target Pseudomonas in people with CF include:

• BiomX Inc. began dosing patients in June in Part 1 of a Phase 1b/2a study to test the safety and tolerability of phage therapy. Results from Part 1 are expected in the first half of 2023, followed by results from Part 2 in the second half of the year.
• Armata Pharmaceuticals will complete enrollment in its Phase 2a trial by the end of 2022. Top-line data are expected in 2023.

Advocacy

In addition to investing in infection research, the Foundation has been advocating for passage of the PASTEUR Act — federal legislation to support the development of new antibiotics and promote appropriate use of existing ones. In addition to meeting with members of Congress, the Foundation partnered with five organizations to launch a grassroots advocacy campaign to promote PASTEUR.

Want to join the effort? Urge your member of Congress to cosponsor the PASTEUR Act today.

The Cystic Fibrosis Foundation periodically sends out information regarding our infection research efforts. To learn more about drugs in development and current studies, please check out the links below.

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