Pasithea Therapeutics (KTTA) Stock: Why It Increased Over 20% Today

By Amit Chowdhry ● Aug 11, 2022
  • The stock price of Pasithea Therapeutics (KTTA) increased by over 20% pre-market today. This is why.

The stock price of Pasithea Therapeutics (KTTA) – a biotechnology company focused on the discovery, research, and development of new and effective treatments for psychiatric and neurological disorders – increased by over 20% pre-market today. Investors are responding positively to Pasithea Therapeutics announcing positive results from a preclinical proof of concept study of PAS002, its tolerizing vaccine program in multiple sclerosis (MS).

Earlier this year, a study in Nature showed that a molecule called GlialCAM found in the brain’s white matter is attacked in MS. GlialCAM shares a component of its protein structure that mimics an identical component of the Epstein Barr Virus (“EBV”) Nuclear Antigen-1 – which plays a critical role in triggering MS.

In this proof of concept study, relapsing paralysis was established in a mouse model of relapsing-remitting experimental autoimmune encephalomyelitis (EAE), the standard animal model of MS. And in 3 groups, a proprietary DNA cassette was engineered to encode GlialCAM and injected to potentially block acute disease and its relapse. 

These DNA molecules were designed to protect against paralytic disease by tolerizing the immune system so it would not attack myelin in the brain and spinal cord. And the engineered DNA molecule creates tolerance, working like an ‘inverse vaccine’, and was administered intra-muscularly on days 0, 3, 7, 10, and 14. The study had a standard duration of 32 days.

The data showed that the engineered DNA plasmids provide a high level of efficacy in reducing disease severity and incidence of relapse when administered prophylactically in the EAE model, a widely used relapsing-remitting model of MS.

The key findings from the study include:

1.) Treatment with a DNA tolerizing ‘inverse vaccine’ delayed the onset of paralysis when compared to vehicle (p<0.001);

2.) A statistically significant reduction in disease severity, when compared to vehicle (p=0.002);

3.) A statistically significant reduction in relapse severity, when compared to vehicle (p<0.001);

4.) Treatment with a DNA vaccine prevented disease in approximately 50% of the mice, when compared to vehicle (p=0.004).

The study was conducted at Hooke Laboratories, an independent full-service Contract Research Organization with deep experience in the EAE animal model of MS.

The company plans to present data from this study, including histology data and plasma inflammatory markers, in future major international conferences, and also to submit full data for peer-review publication.

KEY QUOTES:

“The results of this study show that this technology has the potential to tolerize to GlialCAM, a myelin molecule that has molecular similarity to the Epstein Barr Virus that triggers MS. Remarkably, the piece of GlialCAM protein shared between EBV and white matter in the brain is also found in the pox viruses, including monkeypox. Monkeypox is rarely associated with brain inflammation, and this new technology may prove useful as a treatment for brain inflammation caused in certain viral infections.”

— Pasithea’s Chairman / National Academy of Sciences Professor Lawrence Steinman, a leading authority in MS. Prof. Steinman’s research led to the development of the drug Tysabri, which is approved to treat patients with MS and Crohn’s disease

“We’re thrilled with the strong preclinical efficacy data shown in this study. Although early stage, we believe these results demonstrate the promise and validity of our tolerizing approach, which is built on recent data on the biological mechanism linking infection with EBV with the development of MS. We have filed a provisional patent application and we will continue to rapidly pursue the PAS002 drug development program.”

— Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea