NEW YORK – Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company, 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 study, involving 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, according to the company’s latest update.
The third cohort received an average dose of 500 micrograms subcutaneously and, like the previous lower doses of 125 and 250 micrograms, showed no adverse reactions or tolerability issues.
PT00114, a synthetic version of the natural brain peptide TCAP, has shown promise in preclinical studies for conditions such as anxiety, depression, post-traumatic stress disorder and addiction. The compound is expected to be administered once weekly via subcutaneous injection based on its preclinical pharmacology.
The ongoing Phase 1/2a study, led by Dr. Maurizio Fava, psychiatrist-in-chief at Massachusetts General Hospital, also includes patients diagnosed with treatment-resistant depression, post-traumatic stress disorder or generalized anxiety disorder. The study incorporates biomarker assessments, including circulating cortisol levels, to assess initial response to treatment.
Enrollment for the final two cohorts in the single-dose portion of the Phase 1 study is expected to begin within the next month. Axiom Real-Time Metrics, a CRO/Data Analytics company, manages the clinical program.
This update is based on a press release from Protagenic Therapeutics. The Company cautions investors against forward-looking statements, which are subject to various risks and uncertainties. The next clinical progress update for PT00114 is expected in April 2024.
Insights on InvestingPro
As Protagenic Therapeutics, Inc. (NASDAQ:PTIX) continues to make strides in the development of PT00114, its financial health and market performance provide greater context for potential investors. According to the latest InvestingPro data, PTIX holds a market capitalization of approximately $7.76 million.
Despite the challenges faced by many biopharmaceutical companies in advancing clinical trials, PTIX has demonstrated significant price returns, up 29.63% in the past week and an impressive 98.86% increase in the past month.
The company’s performance metrics also reveal that it has been unprofitable over the past twelve months, with return on assets standing at a steep -57.36%. InvestingPro’s fair value estimate for PTIX stands at $1.69 USD, slightly below the previous closing price of $1.74 USD, suggesting the stock may be trading at a fair valuation based on current metrics.
It’s worth noting that PTIX doesn’t pay dividends 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 recommendations from InvestingPro: The company holds more cash than debt on its balance sheet, indicating some degree of financial stability, but it is rapidly burning through cash, which is a critical factor to monitor in the context of its ongoing clinical trials.
Additionally, the stock’s recent performance suggests it is in overbought territory according to the Relative Strength Index (RSI). For more complete analysis and additional insights, there are 11 additional InvestingPro Tips, which can be accessed via the InvestingPro platform.
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