Periodic Reporting for period 1 - TWO-BIRDS (A feasibility study for SYT-510, a first-in-class drug to treat neuropsychiatric disorders through restoring overall balance in brain chemistry)
Reporting period: 2019-08-01 to 2020-01-31
Post-traumatic stress disorder, known as PTSD, is high unmet needs in neuropsychiatric disorders. As victims of trauma, PTSD patients are coerced by their dysregulated brain chemistries to relive their traumatic experiences, where specific triggers provoke fearful symptoms such as flashbacks, intrusive thoughts, nightmares and severe anxiety. Unfortunately, current drugs for PTSD address only specific symptoms and are highly ineffective, with 70% of the over 15 million people suffering from PTSD that are not adequately cured, and instead are at risk of developing substance abuse disorders and committing suicide. The endocannabinoid system is a neural circuit that is highly dysfunctional in PTSD patients, and new drugs that modulate this circuit in a safe and sustainable manner have the potential to be the first effective treatment for PTSD.
Tourette Syndrome is another indication in which deviations in the endocannabinoid system appears to play an important role. The disease affects a lot less patients than PTSD (400,000 in the EU and US), but patients are similarly affected by a lack of effective treatments that reduce symptoms without severely affecting their quality of life.
In this feasibility study, the overall objective was to assess market, clinical and preclinical feasibility of first-in-class endocannabinoid modulators for PTSD and Tourette’s, and to update Synendos’ business plan with results of the study.
Tourette Syndrome is another indication in which deviations in the endocannabinoid system appears to play an important role. The disease affects a lot less patients than PTSD (400,000 in the EU and US), but patients are similarly affected by a lack of effective treatments that reduce symptoms without severely affecting their quality of life.
In this feasibility study, the overall objective was to assess market, clinical and preclinical feasibility of first-in-class endocannabinoid modulators for PTSD and Tourette’s, and to update Synendos’ business plan with results of the study.
Task 1: Define market and user needs
To understand user needs and the disease market, we interviewed KOL psychiatrists, neurologists and patient associations, to understand what they seek in a new drugs, which symptoms are most severe, which segment of patients has the highest needs etc. For market analysis, we performed desktop research, purchased and studied market reports and discussed the deal market with experts in the pharmaceutical industry to further understand their interests when considering new partnerships.
Task 2: Verify the preclinical development roadmap
To ensure the translatability of animal data to humans, we verified our preclinical development strategy by continuing consultations with experts in preclinical efficacy and toxicology models. For efficacy studies, we considered new models that have been validated, and for tox studies, we emphasised identifying a second species and defining for it experimental protocols for GLP tox.
Task 3: Outline clinical and regulatory development pathway
We interviewed clinicians with experience with clinical trails to assess the major hurdles in clinical development of our compound for PTSD and Tourette in order to assess the feasibility of our approach from a clinical and regulatory perspective. This outline serves as a foundation of developing a detailed clinical development plan in the future.
Task 4: Business plan consolidation
All results from the feasibility report were evaluated in an updated business plan.
To understand user needs and the disease market, we interviewed KOL psychiatrists, neurologists and patient associations, to understand what they seek in a new drugs, which symptoms are most severe, which segment of patients has the highest needs etc. For market analysis, we performed desktop research, purchased and studied market reports and discussed the deal market with experts in the pharmaceutical industry to further understand their interests when considering new partnerships.
Task 2: Verify the preclinical development roadmap
To ensure the translatability of animal data to humans, we verified our preclinical development strategy by continuing consultations with experts in preclinical efficacy and toxicology models. For efficacy studies, we considered new models that have been validated, and for tox studies, we emphasised identifying a second species and defining for it experimental protocols for GLP tox.
Task 3: Outline clinical and regulatory development pathway
We interviewed clinicians with experience with clinical trails to assess the major hurdles in clinical development of our compound for PTSD and Tourette in order to assess the feasibility of our approach from a clinical and regulatory perspective. This outline serves as a foundation of developing a detailed clinical development plan in the future.
Task 4: Business plan consolidation
All results from the feasibility report were evaluated in an updated business plan.
In this study we revealed further insight into the market and therefore the feasibility of our drug assets.
MAIN IMPACT: The main impact of the study will be an elaborate market study for PTSD an Tourette as well as a preclinical and (preliminary) clinical development plan. These assets allow Synendos to develop a de-risked strategy to bring it’s unique Selective Endocannabinioid Reuptake Inhibitors (SERIs) to the patient.
SOCIETAL IMPACT: Completing beforementioned tasks increases the chance of Synendos succeeding to bring its drug to the patient, improving the life of patients in PTSD and Tourette Syndrome in dire need for effective therapies.
MAIN IMPACT: The main impact of the study will be an elaborate market study for PTSD an Tourette as well as a preclinical and (preliminary) clinical development plan. These assets allow Synendos to develop a de-risked strategy to bring it’s unique Selective Endocannabinioid Reuptake Inhibitors (SERIs) to the patient.
SOCIETAL IMPACT: Completing beforementioned tasks increases the chance of Synendos succeeding to bring its drug to the patient, improving the life of patients in PTSD and Tourette Syndrome in dire need for effective therapies.