Kailo Pharma Raises $2.1M for Novel PTSD Drug Development

Post-traumatic stress disorder (PTSD) affects an estimated 300 million people worldwide, and current treatments often focus on managing symptoms rather than addressing the root neurological mechanisms. Now, an Israeli startup, Kailo Pharma, is aiming to change that, having secured $2.1 million in funding to advance research into a novel approach to PTSD treatment. The perform, stemming from discoveries at the University of Haifa, centers on a previously unidentified brain process linked to the amplification of fear memories.

Understanding the Amplification of Traumatic Memory

Researchers Dr. Iris Reuveni and Prof. Edi Barkai at the University of Haifa have pinpointed a specific brain mechanism responsible for what they describe as the pathological “amplification” of fear memories. Unlike typical memories, traumatic memories don’t simply record an event; they appear to intensify the neural signal associated with it. Dr. Reuveni explains that this amplification effectively doubles the strength of the memory signal, altering synaptic connections across all neurons involved, not just a portion as seen in normal memory formation. This process is believed to be a key driver of debilitating PTSD symptoms like flashbacks and nightmares, and contributes to the enduring nature of traumatic recall.

Importantly, this amplification mechanism appears to be selective, operating only within neurons associated with traumatic memories. This specificity offers a potential advantage: a treatment could target this process to reduce the intensity of trauma without erasing the memory itself. The goal isn’t to eliminate the recollection of the event, but to lessen its overwhelming emotional and physiological impact, potentially allowing individuals to process the experience more effectively.

A Peptide-Based Nasal Spray: How it Works

The research team, in collaboration with Prof. Chaim Gillon of the Hebrew University, is developing a peptide – a short chain of amino acids, the building blocks of proteins – designed to neutralize this amplification mechanism. The proposed treatment would be administered as a nasal spray, allowing the peptide to reach the central nervous system directly. This delivery method bypasses some of the challenges associated with getting drugs to the brain, potentially increasing efficacy and reducing side effects.

This approach differs from some existing experimental PTSD treatments that focus on erasing memories altogether. According to Dr. Reuveni, attempts to erase memories carry inherent risks, including unintended damage to non-traumatic memories or the creation of fragmented, unreliable recollections. These memory-erasing approaches typically require intervention shortly after the traumatic event, whereas targeting the amplification mechanism could potentially be effective even long after the trauma occurred.

From Lab to Clinic: The Road Ahead

Kailo Pharma, owned by the University of Haifa’s technology transfer company, Carmel, and the venture capital fund NGT Healthcare II, plans to conduct further trials in mice to refine dosage and strengthen the statistical validation of their findings. The funding round, led by NGT with support from the Israel Innovation Authority, will support this preclinical work.

Human clinical trials are anticipated to initiate within approximately three years, with potential commercialization following within five to ten years – contingent upon successful trial results. This timeline reflects the rigorous process of drug development, which includes multiple phases of testing to ensure both safety and efficacy. The Food and Drug Administration (FDA) outlines a detailed process for drug approval, emphasizing the need for robust evidence before a new treatment can be made available to the public.

Beyond Symptom Management: A New Paradigm?

Currently, PTSD treatment primarily involves psychiatric medications to manage symptoms like anxiety and depression, alongside various forms of psychotherapy, such as cognitive behavioral therapy (CBT) and eye movement desensitization and reprocessing (EMDR). Whereas these treatments can be effective for many, they don’t address the underlying neurological changes associated with the disorder. Kailo Pharma CEO Dr. Osnat On highlights the advantage of their approach: “developing a specific peptide that can be administered as a spray is a significant advantage over competitors who offer treatment for symptoms only.”

Tamir Frank, CEO of Carmel, emphasizes the broader impact of this research, stating the goal is “to translate the breakthrough into a solution that will change the lives of millions of sufferers around the world.” University of Haifa President Prof. Gur Alroey adds that the company exemplifies the institution’s commitment to translating academic research into practical applications.

What to Expect in the Coming Years

The next phase of research will be crucial in determining whether the findings from mouse models translate to humans. Clinical trials will need to carefully assess not only the efficacy of the peptide in reducing PTSD symptoms, but as well its safety profile and potential side effects. Researchers will also need to investigate whether the treatment is effective across different types of trauma and in individuals with varying levels of symptom severity. The Department of Veterans Affairs National Center for PTSD provides extensive information on ongoing PTSD research and treatment options.

If clinical trials are successful, this novel approach could represent a significant step forward in the treatment of PTSD, offering a potential pathway to address the underlying neurological mechanisms of the disorder and improve the lives of millions affected by trauma. Although, it’s important to remember that this research is still in its early stages, and much work remains to be done before a new treatment becomes widely available.