Sionna Therapeutics Announces Phase 1 Initiation for SION-109 in Cystic Fibrosis

– SION-109 is a small molecule targeting the interface between the ICL4 region and the NBD1 domain of the CFTR protein; designed to complement the company’s NBD1 modulator portfolio –

– First subject dosed in Phase 1 clinical trial –

Boston, MA, January 24, 2024 — Sionna Therapeutics, a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF), announced that the first healthy subject has been dosed in a Phase 1 clinical trial of SION-109 following clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA).

SION-109 is a small molecule designed to target the interface between the intracellular loop 4 (ICL4) region and the first nucleotide-binding domain (NBD1) of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. It is a complementary mechanism to the company’s portfolio of compounds directly targeting NBD1, including SION-638, the first-in-class NBD1 stabilizer now in Phase 1.

“Our ability to target NBD1 correction is truly novel, and with SION-109 now entering clinical development, we have the opportunity to develop proprietary combination treatments that have the potential to achieve full CFTR correction,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “Advancing our second investigational drug into Phase 1 is an achievement made possible by the tireless work of our research and development teams, who have deep experience in CF and a sharp focus on advancing these programs rapidly to deliver new options for people living with CF and their families.”

CF is caused by genetic mutations in the CFTR protein, an epithelial ion channel that is essential for producing healthy, freely flowing mucus in the airways, digestive system, and other organs. The most common mutation in CFTR, ΔF508, causes NBD1 to unfold at body temperature and severely impairs CFTR function. Complementary targets including ICL4 may enable combination treatments with the potential for full CFTR correction. It is estimated that 90 percent of people living with CF have the genetic mutation ΔF508... Sionna Therapeutics' Press Release - 

NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

The Air Next Spirometer was granted 510k approval for in-home use by the NuvoAir clinical team and its clinical trials partners.

January 25th, 2024 – Boston, MA: NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir to scale and expand clinical operations to ensure no patient with heart or lung conditions is left behind.

510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary. For patients with conditions like COPD, Asthma, or ALS, using this easy-to-use device at home means they don’t have to wait for an in-person appointment or plan the logistics for travel.

“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” says Eric Harker, MD MPH MBA, and Chief Medical Officer at NuvoAir. “Spirometry has traditionally been underutilized as a diagnostic and monitoring tool because of the logistical challenges of getting complex patients to a clinic with regularity. In-home spirometry empowers our practice to provide continuous care to our patients in the home with real-time, high-quality, and actionable clinical data.”

By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe. “Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” says Furat Shawki, General Manager of Clinical Trials at NuvoAir. “With in-home approval of ATS 2019-compliant spirometry, we can look forward to scaling our services with our partners across the healthcare ecosystem, including healthcare providers and clinical trials, so we can deliver the cardiopulmonary care that people desperately deserve to the places that need it most.”... NuvoAir Medical's Press Release -