PolTREG plans to start a pivotal Phase II/III trial of PTG-007 for the treatment of type 1 diabetes and is pursuing partnership funding. Image Credit: Anatoliy Cherkas / Shutterstock.

PolTREG has presented positive long-term data for its cell therapy, PTG-007, showing that the therapy induced clinical remission for type 1 diabetes (T1D) for up to 12 years.

The follow-up data from 54 patients with early-onset T1D who took part in Phase I and II trials was presented at the European Association for the Study of Diabetes (EASD) taking place from 9 to 13 September in Spain. In light of the positive data, the Polish company will start a pivotal Phase II/III trial of PTG-007 for the treatment of T1D and is pursuing partnership funding.

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“Today’s results are extremely encouraging and show that some patients remain in clinical remission for up to 12 years after initial treatment,” said Professor Piotr Trzonkowski, PolTREG’s CEO.

“This makes us very eager to launch a pivotal study of PTG-007 as soon as we find a suitable partner.”

The 54 patients with early-onset T1D were followed for 7-12 years after receiving initial treatment as part of Phase I and Phase II trials. The study showed that a “proportion of patients” remained insulin-independent up to 18 to 24 months after treatment.

Additionally, some of the patients remained in clinical remission for 7-12 years after being treated with PTG-007. The trial defined clinical remission as having a low need for external insulin while retaining proper metabolic/glycaemia control.

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The study also found that the “best results” were seen in patients who received the combination therapy of Treg therapy and Roche and Biogen’s anti-CD20 treatment Rituxan (rituximab).

PolTREG plans to release detailed data and publish the results in a peer-reviewed scientific publication, as well as initiate a Phase II trial evaluating PTG-007 in patients with presymptomatic T1D. The company also plans to start first-in-human trials evaluating the Treg therapy as a treatment for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).

Cell therapies as a treatment for T1D are gaining popularity. Last year saw the US Food and Drug Administration (FDA) approving the first cell therapy, CellTrans’s Lantidra (donislecel) for the treatment of T1D.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.