Sponsored by ReCode Therapeutics
Despite the availability of CFTR modulators that work for 90% of people with CF, many will not be able to take the medication due to side effects, lack of response, or other reasons. About 10% of the CF community have genetic mutations that do not benefit from these therapeutics, or are unable to tolerate these therapies, creating a critical unmet need within the community. ReCode Therapeutics Inc. has developed a potential new genetic therapy (RCT2100) for CF. RCT2100 is an inhaled mRNA treatment that works by sending a message that tells the cells to produce functional CFTR protein. This trial aims to find out the safety of this investigative inhaled therapy and see if it may work as a potential new treatment option for people with CF who are not eligible for CFTR modulator therapy. RCT2100 works by telling the cells to create a CFTR protein that functions normally and may improve lung function in people with CF.
ReCode is now enrolling patients into Part 3 of RCT2100 in a combination study with ivacaftor. By participating in this trial, community members not only access potential new therapies but also play a vital role in shaping the future of CF treatment—helping researchers uncover what works, and for whom, to accelerate progress for everyone facing the disease. This trial is being conducted in strict accordance with ethical and regulatory guidelines, ensuring participant safety and well‑being. Typically, participation includes a screening visit (around 2–4 hours) to determine eligibility, followed by a treatment phase lasting 6 weeks, and a follow‑up period of up to 24 weeks which is a total of 30 weeks. Participants will undergo a series of tests and procedures throughout the study—this includes physical exams, vital signs, ECG, chest X‑ray, pulse oximetry, spirometry, and blood and urine tests. Eligibility for this trial is centered on individuals with CF who do not take CFTR modulators—either due to ineligibility, intolerance, or
lack of access—and who are therefore those most in need of innovative therapeutic approaches. Participants are reimbursed for travel and may receive additional stipends, and all required tests and procedures are covered at no cost to them.
For more information, please visit below websites or contact ReCode team at
clinicaltrials@recodetx.com
– https://clinicaltrials.gov/study/NCT06237335
– https://cf-clinical-studies.com/
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