NEW YORK - Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company, has reported progress in the development of its novel treatment for stress-related neuropsychiatric disorders.
The company announced the successful completion of three out of five cohorts in a Phase 1 clinical trial for PT00114, a synthetic stress-regulating peptide.
The trial, which involves healthy volunteers, is designed to evaluate the safety and tolerability of PT00114. To date, the compound has been well-tolerated with no adverse safety findings, as per the company's latest update.
The third cohort received a medium dose of 500 micrograms subcutaneously, and like the previous lower doses of 125 and 250 micrograms, it showed no adverse reactions or tolerability issues.
PT00114, a synthetic version of the naturally occurring brain peptide TCAP, has shown promise in preclinical studies for conditions such as anxiety, depression, PTSD, and addiction. The compound is expected to be administered once weekly via subcutaneous injection based on its preclinical pharmacology.
The ongoing Phase 1/2a trial, under the leadership of Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, also includes patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The trial incorporates biomarker assessments, including circulating cortisol levels, to gauge initial treatment response.
Enrollment for the final two cohorts in the single-dose portion of the Phase 1 trial is expected to commence within the next month. Axiom Real-Time Metrics, a CRO/Data Analytics firm, is managing the clinical program.
This update is based on a press release statement from Protagenic Therapeutics. The company cautions investors about forward-looking statements, which are subject to various risks and uncertainties. The next clinical progress update for PT00114 is anticipated in April 2024.
InvestingPro Insights
As Protagenic Therapeutics, Inc. (NASDAQ:PTIX) continues to make strides in the development of PT00114, its financial health and market performance provide a broader context for potential investors. According to the latest InvestingPro Data, PTIX holds a market capitalization of approximately $7.76 million USD.
Despite the challenges faced by many biopharmaceutical companies in advancing clinical trials, PTIX has demonstrated significant price returns, with a 29.63% increase over the last week and an impressive 98.86% surge over the past month.
The company's performance metrics also reveal that it has not been profitable over the last twelve months, with a return on assets standing at a steep -57.36%. The InvestingPro Fair Value estimate for PTIX stands at $1.69 USD, slightly below its previous close price of $1.74 USD, suggesting that the stock may be trading at a fair valuation based on current metrics.
It is worth noting that PTIX does not pay a dividend to shareholders, which is common for companies focused on growth and reinvestment in research and development.
Investors considering PTIX should be aware of two key InvestingPro Tips: the company holds more cash than debt on its balance sheet, indicating a degree of financial stability, yet it is quickly burning through cash, which is a critical factor to monitor in the context of its ongoing clinical trials.
Moreover, the stock's recent performance suggests it is in overbought territory according to the Relative Strength Index (RSI). For a more comprehensive analysis and additional insights, there are 11 more InvestingPro Tips available, which can be accessed through the InvestingPro platform.
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