Precigen Reports Addl. Positive Data From Study Of AG019 ActoBiotics For Type 1 Diabetes Treatment

(RTTNews) - Precigen ActoBio, a wholly-owned subsidiary of Precigen Inc. (PGEN), announced additional positive interim data from the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics for the treatment of recent-onset type 1 diabetes or T1D.

The company noted that AG019 showed stabilization of the long-term glycemic control markers, HbA1c and IDAA1c, for the majority of patients treated with the AG019 monotherapy and AG019 combination therapy.

Antigen-specific immune modulation, which is the keystone for the mechanism of action of AG019 as demonstrated in preclinical studies, is now translated into the immunological clinical data in the Phase 1b/2a clinical study.

The company state that the new data presented at EASD strengthens previously reported findings on C-peptide and antigen-specific immune modulation, and the exciting data for the AG019 monotherapy reinforces its belief that AG019 is promising as a standalone therapy.

The company looks forward to further investigating the potential of AG019 in type 1 diabetes.

The Phase 1b open-label portion of the study evaluates the safety and tolerability of AG019 as a monotherapy in adult (age 18-42) and adolescent (age 12-17) patients. The Phase 2a double-blind portion of the study investigates the safety and tolerability of AG019 in combination with an investigational anti-CD3 monoclonal antibody, teplizumab (PRV-031).

Previously reported Phase 1b/2a data showed the potential of oral AG019 treatment to preserve insulin production in recent-onset T1D through its capacity to induce antigen-specific immune modulation.

New AG019 monotherapy data show that glycated hemoglobin (HbA1c) was below the 7% target for 100% of adult patients (9 of 9) and 92% of the patients aged 17 years and above (11 of 12) up to 12 months after dosing initiation.