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Pre-clinical Trials

Background

The most recent and hopeful new approach in drug development currently focuses on those cells that cause inflammation in the brain, specifically microglia (See Economist, June 7, 2025).

A number of drugs have been developed to target a protein TREM2 on the surface of microglial cells in an effort to increase neuroinflammation. In June 2024 Sanofi invested an initial US$40 million to Vigil Neuroscience for the rights to their TREM2-derived drug.

However, Septa's disease model shown in Technology suggests that while increasing microglial inflammation may be effective initially, prolonged or excessive activation would likely increase neuroinflammation and neuronal damage . The model says that it isn't chronic viral infection that causes the most damage in the brain – it's the prolonged neuroinflammation that kills neurons.

Therefore, our approach is to deplete the number of microglia available at the source (Abeta) and decrease neuroinflammation.

Which approach is correct?

Sanofi/Vigil drug showed promise for the treatment of AD, Parkinson's Disease and Multiple Sclerosis in early trials, but failed phase 2 clinical trials. (April 2025). It appeared that after prolonged activation, the TREM2 agonist made disease symptom worse, as Septa's model predicts.

Work is continuing in various labs on a similar TREM1 receptor but no trial results are available.


Septa Therapeutics' Pre-clinical trials

Septa Therapeutics has devoted 2024 and 2025 to the development of a series of inflammation blockers. We have employed cellulose-bound peptide arrays to construct blockers which will pass through nasal membranes, bind to Amyloid-beta in the brain and which meet all new US patent office requirements for patentability (USPTO eligibility statute 35 USC section 101). These latter requirements have been connected to recent political changes occurring since our earlier filing in 2018.

Pre-clinical trials have been initiated with Charles River Discovery Research Services Finland, Ltd. We are now preparing to start Phase 1 trials Jan 2, 2026, using Tg2576 mice. STAY TUNED.