PolTREG, a Polish biotech company developing Treg therapies, has unveiled results from a clinical study demonstrating the long-term safety and efficacy of PTG-007 in patients with early-onset type-1 diabetes for up to 12 years.
Type-1 diabetes (T1D) is an autoimmune disease where the immune system attacks the pancreas, eventually rendering it unable to produce insulin. There are currently no treatments that can target the underlying cause of the disease and regenerate the pancreas’ ability to produce insulin.
Treg therapy could hold promise in T1D by stopping the immune system from attacking the pancreas at the onset of the disease, before all insulin production is lost.
In PolTREG’s clinical trial, patients with T1D who received PTG-007 continued to secrete insulin, while untreated patients did not. Those who received the Treg therapy also showed a longer period of disease remission of up to 4 years. The therapy did not show any safety concerns.
Long-term safety of Treg therapy
“We believe that PTG-007 has the potential to prevent type-1 diabetes, freeing patients of the life-long burden of having to take frequent insulin injections, and the serious long-term complications of the disease. The results of this study are an important step in that direction,” said Piotr Trzonkowski, Chief Executive Officer of PolTREG.
The clinical study followed patients over a period of 7 to 12 years, making it the longest trial so far to test the long-term safety of Treg therapy in type-1 diabetes.
Following the positive trial results, PolTREG plans to launch a pivotal phase 2/3 study with PTG-007, which will be the final step required to apply for regulatory approval. The company is also planning to launch a phase 2 study testing the treatment in T1D patients who are not yet showing any symptoms of the disease.
PolTREG, a pioneer in Treg technology, was the first company in the world to study Treg therapies in humans and its cell therapy manufacturing facilities are one of Europe’s largest.
Later this year, PolTREG will launch a phase 2 trial with PTG-007 in patients with multiple sclerosis (MS). Next year, the company will start a first-in-human trial of CAR-Tregs to treat MS and amyotrophic lateral sclerosis.