Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 185

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 185
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 in combination with galicaftor.

In Phase 1 trials evaluating safety and tolerability in healthy subjects, navocaftor was generally well-tolerated in combination with galicaftor, in
each case at doses up to 500 mg twice daily for 14 days. These trials were conducted in Europe and the U.S. In addition, navocaftor has been generally well-tolerated in both CF subjects and healthy volunteers. When navocaftor was given as a
monotherapy or in combination with galicaftor, all AEs were mild to moderate. The PK profile in CF patients was similar in healthy volunteers.

The
activity of navocaftor in patients with CF was evaluated in a randomized, double-blind, placebo-controlled Phase 2 trial in combination with a galicaftor dose range from 10 mg to 300 mg QD, as summarized above. Combination treatment of navocaftor
150 mg QD with galicaftor resulted in improvements in FEV and sweat chloride levels in the homozygous F508del population. As expected, treatment with 50 mg QD or 150 mg QD navocaftor
monotherapy for 28 days did not result in improvements in FEV or sweat chloride levels.

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Manufacturing

We have leveraged multiple third-party manufacturers to support the manufacturing of our product candidates for clinical trials and, if we receive
regulatory approval, we intend to rely on third parties for commercial manufacture. We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We expect this strategy will enable us to maintain a more efficient
infrastructure, outsourcing instead of building manufacturing and supply chain capabilities, while simultaneously enabling us to focus our expertise on the clinical development of our product candidates. We expect to enter into commercial supply
agreements with such manufacturers prior to any potential approval of our product candidates.

Commercialization

We have exclusive worldwide commercial rights to our product candidates. Given our stage of development, we have not yet established a commercial
organization or distribution capabilities. The CF patient populations are well-characterized and clearly identified in the U.S., Canada, Europe and several other regions around the world, with highly active and informed CF patient advocacy groups.
Most CF patients are treated at a limited number of centralized CF patient care centers by a team of healthcare professionals who are experts in and dedicated to treating CF.

We plan to independently commercialize our products, if approved, in the U.S. and other