Shares of Precigen (PGEN) - Get Report jumped Friday after the company said that in a Phase 1b/2a study, its AG019 ActoBiotics, a therapy designed to address the underlying cause of type 1 diabetes, met its primary endpoint.
At last check Precigen shares were 10% higher at $7.70. The shares have traded on Friday up as much as 25% at $8.72.
The Germantown, Md., company's treatment candidate was studied in Phase 1b as a monotherapy for adults ages 18 to 42 and adolescents ages 12 to 17; and in Phase 2a as a combination therapy with teplizumab.
"We are encouraged by the Phase 1b/2a primary analysis results and the implications for the potential of AG019 as an easy-to-take oral monotherapy or combination therapy with teplizumab," Pieter Rottiers, chief executive of Precigen's ActoBio division, said in a statement.
The results "suggest the ability of AG019 to modulate a patient's immune system in a precise, antigen-specific manner to address the underlying cause of T1D."
All data from patients who received at least 75% of the scheduled doses of AG019 and at least one dose of teplizumab showed no major issues in their treatment.
With Type 1 diabetes, the immune system destroys insulin-producing beta cells in the pancreas, resulting in a blood-glucose imbalance.
As of 2019, more than 463 million adults are diagnosed with diabetes. Type 1 diabetes accounts for between 5% and 10% of those cases.
"The primary analysis shows that AG019 can be administered safely, either as a monotherapy or in combination with teplizumab and provides an opportunity for chronic treatment of T1D," said Kevan Herold, professor of immunobiology and medicine at Yale University. He is principal investigator for the AG019 Phase 1b/2a clinical study.