FDA meeting on inhaled nanoparticle therapy called 'a major milestone'
By Marisa Wexler, MS | May 22, 2024
Evoq Bio said it successfully completed a meeting with the U.S. Food and Drug Administration (FDA), held to discuss the development of its inhaled nanoparticle therapy for treating bacterial lung infections in people with cystic fibrosis (CF) and other lung disorders.
According to the company, a subsidiary of Evoq Nano, the FDA responded favorably during the pre-investigational new drug (pre-IND) meeting. An investigational new drug application, or IND, is a formal request to the FDA asking for permission to start clinical testing, or trials in people, of an experimental therapy.
“The positive response from the FDA to our nanomedicine platform is a major milestone in the development of a new treatment for patients with cystic fibrosis and other bacterial lung infections,” Shaun Rothwell, CEO of Evoq Nano, said in a company press release.
The release stated that Evoq Bio now “is confidently advancing toward Phase [1] clinical trials.”
EVQ-218 shown in lab to work against bacterial lung infections
CF is a genetic disorder characterized by abnormally thick and sticky mucus in the lungs and other organs. This thick mucus can serve as a haven for infectious bacteria, and chronic lung infections are a common problem in people with CF.
Moreover, infections with bacteria that are resistant to commonly-used antibiotics are becoming increasingly more prevalent, underscoring a need for new treatment options. Evoq’s new therapy, dubbed EVQ-218, is a silver nanoparticle molecule that’s been shown in lab experiments to be able to kill a range of problematic bacteria, including Pseudomonas aeruginosa, that frequently cause chronic lung infections in people with CF. Called P.aeruginosa, this bacteria is commonly found in the environment.
According to the company, EVQ-218 also is able to kill other single-celled organisms like yeast, but it has not demonstrated any toxic effects against lung cells in preclinical tests.
Further, EVQ-218 also can penetrate more than a dozen different biofilms — thick, protective coverings that infectious lung bacteria produce to help them evade destruction. In lab experiments, bacteria did not develop resistance to EVQ-218 after nearly a month of treatment. In similar experiments with conventional antibiotics, resistance can usually be detected in less than a week, according to Evoq.
The company is developing an inhaled version of EVQ-218 to be delivered directly into the lungs as a way to combat bacterial lung infections. While Evoq now is planning early clinical trials, it did not provide a specific timeline for the therapy’s development. To date, the company has received two grants from the Cystic Fibrosis Foundation to develop an inhaled therapeutic using EVQ-218.