Protagenic Therapeutics' Stress-Regulating Peptide Shows Exceptional Safety in Phase I Trial

Protagenic Therapeutics, Inc. (NASDAQ:PTIX), an innovator in the biopharmaceutical sector, has disclosed the complete safety data from the single dose segment of its Phase 1 clinical trial for PT00114. PT00114 is a synthetic version of a natural brain peptide designed to regulate stress. This trial included 30 participants divided into five cohorts, each receiving different doses, with the maximum dose being 1,000 micrograms. The results were noteworthy as there were no clinically significant adverse events reported.

PT00114's primary objective is to mitigate stress, which is increasingly linked to several major psychiatric disorders such as PTSD, depression, anxiety, and addiction. Additionally, recent studies have indicated that stress might also contribute to obesity. By focusing on the chemical processes triggered by stress, PT00114 aims to provide an innovative treatment option for these conditions.

Dr. Robert B. Stein, the Chief Medical Officer, expressed enthusiasm about the trial's safety results, describing them as "highly encouraging." He emphasized the company’s eagerness to proceed with the multiple ascending dose portion of the trial later this year. According to Dr. Stein, PT00114 holds significant promise in transforming the treatment landscape for various stress-related disorders.

On May 22nd, at 10:00 am ET, Protagenic Therapeutics will host an interactive investor call to discuss the safety data and the potential implications of PT00114 for treating mental health issues and obesity. This call provides a platform to delve into how PT00114 could meet the unmet needs in these areas.

PT00114 is formulated to act as a therapeutic agent for severe neuropsychiatric conditions by mimicking the naturally occurring brain peptide TCAP. This mimicking action helps to counteract the hormonal effects induced by stress, targeting the root cause of numerous psychiatric and stress-related disorders.

The compelling safety profile observed in the initial phase of the trial sets a strong foundation for further research. Protagenic Therapeutics is poised to continue its investigations into PT00114, with the aim of uncovering its full therapeutic potential. The anticipation surrounding the multiple dose portion of the trial is palpable, as it will provide further insights into the efficacy and safety of PT00114.

In summary, Protagenic Therapeutics' recent announcement marks a significant milestone in the development of PT00114, a compound with the potential to revolutionize the treatment of stress-induced conditions. The absence of clinically relevant adverse events in the single dose trial phase is a promising indicator of the drug's safety profile. As the company moves forward with its research, the medical community and investors alike will be watching closely to see how PT00114 performs in subsequent trials and its potential impact on treating stress-related psychiatric disorders and obesity.