Long-term Effects with Repeated ProTrans Treatment After 6 Years

NextCell Pharma AB reports new results from the ProTrans-Repeat study, where type 1 diabetes patients have been followed for 5 years after receiving two doses of the stromal cell product ProTrans, in total 6 years after the first infusion. The results show that two out of three patients in the high-dose group increased their insulin production by 23% and 34% respectively.

Long-term Effectiveness and Safety
ProTrans-1, a dose-escalation study completed in 2019, demonstrated that ProTrans treatment is safe and that higher doses of the drug product provides therapeutic efficacy. Patients who received the highest dose of 200 million cells, demonstrated a significant preservation of their insulin production one year after treatment compared to those who received lower doses.

In the follow-up study, ProTrans-Repeat, patients from ProTrans-1 were treated with an additional dose of ProTrans 1–1.5 years after the initial infusion. Earlier interim analyses showed that the high-dose group retained, on average, 81% of their insulin production 3.5–4 years after the first dose, compared to 41% and 45% in the low- and medium-dose groups.

Results After 6 Years
We now demonstrate that 6 years after the first infusion, the high-dose group (n=3) retained, on average, 91% of their insulin production. Two patients increased their production by 23% and 34%, while the third experienced a decline. In the low- and medium-dose groups, retained insulin production after 6 years averaged 26% and 47%, respectively.

"The results from the ProTrans-Repeat study are highly encouraging, showing that repeated treatment can preserve and even improve insulin production over 6 years. This strengthens ProTrans’ potential as a safe and effective therapy for modifying the progression of type 1 diabetes", says Mathias Svahn, CEO.

A summary of insulin production as a percentage of baseline is provided below:

The control patients were included when the ProTrans-Repeat trial began, 1–1.5 years after other patients. Their type 1 diabetes diagnoses varied between 2 months and more than 2 years prior to inclusion.

Connection to Previous Findings

These data reinforce earlier findings on ProTrans’ long-term effectiveness. In October 2023, NextCell reported that a single treatment with ProTrans could slow disease progression for over 5 years. These new results suggest that repeated treatment can further enhance long-term outcomes, particularly with higher doses. While later timepoints lack statistical significance due to the small group sizes, a clear trend is evident and in line with our previous datasets showing that ProTrans modifies the disease progression of type 1 diabetes, long-term.

In September 2023, we reported that ProTrans is immunologically safe when used for repeated treatments. The combination of long-term efficacy and safety highlights ProTrans’ potential as a groundbreaking treatment for autoimmune diseases such as type 1 diabetes.

This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-12-2024 12:50 CET.