S-Alpha Therapeutics, Inc. Presents SAT-014 Clinical Trial Results at the Korean Academy of Anxiety and Mood Fall Meeting

Date : 2024-11-20

“Digital Therapeutics for PTSD and Adjustment Disorder Symptom Improvement”
|SAT-014, an investigational software being developed in form of SaMD(Software as a medicaldevice) for treatment , targetting Post Traumatic Stress Disorder(PTSD) and adjustment disorder(AD), has been evaluated with proof-of-concept clinical trials in collaboration with Samsung Medical Center as part of a national research project.
|Results showed that index for measuring of severity of PTSD/AD has been evaluated with significantly better-improvement in SAT-014 group than in Control group (P<0.05).  
|S-Alpha Therapeutics, Inc. is perparing to start pivotal clinical trials in Soth Korea, late of 2024, aiming to offer an effective and safe treatment option to more patients.

 

 

Digital health company S-Alpha Therapeutics, Inc. announced today that it presented the proof-of-concept clinical trial results of its digital therapeutic (DTx) pipeline, SAT-014, at the 2024 Fall Meeting of the Korean Academy of Anxiety and Mood. 

 

S-Alpha Therapeutics is developing SAT-014 as a software medical device (SaMD) to alleviate symptoms of PTSD (post-traumatic stress disorder) and AD(adjustment disorder). Recognizing the need for R&D in non-invasive, low side-effect treatments for stress-related disorders, SAT-014 was selected as a government-backed national research project, and the proof-of-concept clinical trial began since 2023.

 

SAT-014 interventional activities are designed, based on evidence from Mindfulness-Based Cognitive Therapy (MBCT) and Eye Movement Desensitization and Reprocessing (EMDR) through a mobile application. 
Patients follow the app's guidelines to complete activities at designated intervals. The intervention of SAT-014 is composed of 10 mins more or less digital program per day, for 6 weeks.

 

The proof-of-concept clinical trial for SAT-014 was conducted at Samsung Medical Center with 19 patients diagnosed with PTSD and adjustment disorder. The treatment group used SAT-014 for six weeks, while the control group continued TAU(Treatment As Usual). Results showed significant reductions in scores for PTSD severity (PCL-5), depression (PHQ-9), and anxiety (BAI) in the treatment group compared to the control group. No device-related adverse events were reported.

 

The proof-of-concept clinical trial for digital therapeutics is an exploratory process to assess the efficacy and safety of the pipeline. Based on these results, the next step is pivotal clinical trials with a larger patient population, followed by commercialization. S-Alpha Therapeutics plans to begin domestic pivotal clinical trials for SAT-014 in 2024. 

 

In addition to SAT-014, S-Alpha Therapeutics is developing a range of digital health solutions targeting unmet medical needs in areas with limited or no standard treatments, including SAT-001 (myopia) and SAT-003 (cancer cachexia). SAT-001 is being co-developed in collaboration with Japanese pharmaceutical company Rohto Pharmaceutical, which holds a significant share in the global eye drop market. 

 

A spokesperson for S-Alpha Therapeutics stated, “The greatest strength of digital therapeutics is the ability to provide an effective and safe treatment option. We hope the successful use of SAT-014 will improve the quality of life and treatment environments for patients with PTSD and adjustment disorders.”
 

 

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