NextCell Pharma

On 7th April 2025, NextCell Pharma released a press release announcing the topline data from its administrative analysis of the older age cohort from the ProTrans-Young paediatric clinical trial. The study is evaluating the safety and efficacy of the company’s cell therapy, ProTrans, in preserving insulin production in young individuals newly diagnosed with type 1 diabetes, compared with placebo. The current analysis is of the first 30 randomised patients, all included within six months of diagnosis – a favourable time point, as more insulin production is typically still present and can be preserved.

In her interview with Flemingsberg Science, Dr Davies discussed the data achieved and how the company is interpreting the findings. “We are strongly encouraged by the dataset. It is important to remember the aims of this trial in asking the questions of can we safely treat children with ProTrans and secondly can we target the disease earlier in its development than we have previously. We can absolutely say that the drug product is safe for children and early indications are that yes, we can target earlier in the disease than previously thought”. Lindsay cited the top line data that no severe adverse side effects had been reported within the Phase I arm of the study and that in the Phase II older age cohort the data already demonstrated strong trends that a clinical effect was evident in preserving insulin production in ProTrans treated individuals.

She added, “It is important to not directly compare the data to our earlier trial in adults at this point. We need to consider that this is a live cell therapy dependent on an immune modulating effect that is going to be impacted by the immune system and biochemistry of the treated individual. We are interestingly already seeing trends related to sex, with females demonstrating a 19% loss in insulin with ProTrans treatment compared to 25% loss in the placebo group and males averaging a loss of 22% insulin with ProTrans treatment compared to 28% in the placebo group. Earlier intervention means that it will take longer to see the clear impact of the treatment compared to placebo – this is why this study will run for 5 years to monitor the evolution of the disease. To already see differences and trends is fantastic!”

Lindsay’s interview with Natasha Bank, Cluster Manager at Fleminsgberg Science can be watched at the following link https://youtu.be/XxUGNZ8pCP4.