A group comprised of Boehringer Ingelheim, IP Group, the UK Respiratory Gene Therapy Consortium, and CDMO OXB, has announced the initiation of the Phase 1/2 Lenticlair 1 study of BI 3720931, an inhaled lentiviral vector-based gene therapy in adult cystic fibrosis patients who cannot be treated with CFTR modulators. The trial is expected to be completed in 2027.
Boehringer Ingelheim and the other organizations announced in 2018 that they had partnered to develop an inhaled gene therapy to insert a functional copy of the CFTR gene into airway cells. The therapy is intended to benefit CF patients, no matter which mutation causes their disease.
Gene Therapy Consortium coordinator Professor Eric Alton of Imperial College London commented, “The GTC is very excited to have reached this milestone after 24 years of focused effort and in close collaboration with our partners and people with CF. While the immediate target are those adult patients who are not eligible for CFTR modulators, this novel therapy has the potential to achieve long-lasting CFTR function improvement and disease modification for people with CF irrespective of mutation type and has the potential for re-dosing if needed. We are very grateful to our wonderful team, our partners and funders and those with CF who have and continue to support us in many ways, including taking part in the multiple trials.”
Boehringer Ingelheim board member Paola Casarosa said, “We are very excited about the start of the Lenticlair 1 First-In-Human trial and how BI 3720931 could potentially improve the lives of people living with CF, and who are unable to benefit from current CFTR modulators. This is a crucial moment in the development of BI 3720931, which we have progressed together with our partners since 2018. The partnership with the GTC and OXB provides an excellent example of the progress that can be made when diverse organizations and people come together with a long-term, shared goal to create a new paradigm of care.”
Read the Boehringer Ingelheim press release
