- Precigen Inc's PGEN subsidiary Precigen ActoBio announced topline results from the Phase 1b/2a study evaluating AG019 ActoBiotics to treat recent-onset type 1 diabetes (T1D).
- Results were presented at the Federation of Clinical Immunology Societies 2021.
- Phase 1b AG019 monotherapy and the Phase 2a AG019 combination therapy met their primary endpoint.
- Following a single 8-week treatment cycle of oral AG019 as monotherapy, 56% of adult patients showed stabilization or higher C-peptide levels during the first six months post-treatment initiation.
- Results indicated the potential of oral AG019 monotherapy to preserve insulin production in recent-onset T1D through its capacity to reduce autoreactive T cells and increase the frequency of memory Tregs to induce antigen-specific immune modulation.
- Following treatment with the combination of AG019 and Provention Bio Inc's PRVB teplizumab, 70% of adult patients and 100% of adolescent patients showed stabilization or increase of C-peptide levels at six months post-treatment initiation, with overall stabilization of 79%.
- AG019 was well tolerated and safe when administered to adults and adolescents either as monotherapy or in combination with teplizumab.
- No serious adverse events were reported, and no AG019 treatment discontinuation occurred due to the adverse events.
- Price Action: PGEN shares are up 38.3% at $9.67 during the premarket session on the last check Friday.
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