Clinical trial of potential diabetes and arthritis treatment delivers positive results

Immutep Ltd (ASX: IMM) has reported positive results from a clinical trial of a drug it is developing in a bid to treat autoimmune diseases in a novel fashion.

The biotechnology company said in a statement to the ASX on Monday morning that the "single-ascending dose escalation" portion of the phase one clinical trial of its compound, IMP761, had completed the 2.5 and 7mg per kg dosing levels, "with continued positive safety and efficacy data".

As the company said:

IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose-dependent immunosuppressive effects with IMP761 was observed with significant, long-last inhibition of the three T-cell mediated intradermal reactions to a strong foreign antigen at day 2, 9 and 23.

Key milestone for the company

Immutep's Chief Scientific Officer, Dr Frederic Triebel, said the results were encouraging.

He went on to say:

We are excited to see IMP761 having a long-term immunosuppressive effect after a single injection. A solid pharmacokinetic/pharmacodynamic relationship has now been established between 1 and 7mg per kg with eight participants per group to cover the variability of the responses. This novel immunotherapy's significant level of immune suppression combined with its favourable safety provide proof of concept data in its potential to silence the dysregulated T cells at the epicentre of many autoimmune diseases. Encouragingly our clinical progress with IMP761 has corresponded with increased external interest in the program.

Various ailments in focus

Immutep said the LAG-3 "immune checkpoint" has been identified as a promising therapeutic target for many autoimmune diseases, including rheumatoid arthritis, type 1 diabetes, and multiple sclerosis.

It went on to say:

IMP761 is the first LAG-3 agonist antibody developed to potentially treat these large, increasingly prevalent disorders, each of which represent multi-billion dollar markets. By enhancing the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells, IMP761 is designed to target the cause of autoimmune diseases and restore balance to the immune system. LAG-3 expression on activated T cells demonstrates high specificity for disease sites, especially in regions characterised by chronic inflammation. This distinct characteristic of the LAG-3 immune checkpoint suggests IMP761 may enable a more targeted therapeutic approach with fewer adverse effects compared to other treatments.

Immutep said the clinical trial would continue, with further updates expected in the first half of calendar 2026, including a potential presentation of the trial data at a major medical conference.

The company's shares were 0.7% lower at 39.3 cents on the news on Monday morning.

Immutep was valued at $582.1 million at the close of trade on Friday.

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