EDISON, N.J. - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company, announced today the cessation of its ASCEND-NASH trial, a study aimed at treating non-alcoholic steatohepatitis (NASH), due to financial constraints. The trial's discontinuation comes despite no safety concerns being observed with the investigational drug rencofilstat.
The ASCEND-NASH trial, a Phase 2b study that began screening its first patient in August 2022, was designed to assess the safety and efficacy of rencofilstat over a 12-month period. Enrollment was halted in April 2023 after 151 of the targeted 336 subjects had been randomized. Out of these, approximately 80 subjects have completed their Day 365 visits and can be evaluated for safety and efficacy, with an additional 40 expected to provide substantial safety data.
Executive Chairman John Brancaccio expressed disappointment over the need to wind down the trial, attributing the decision solely to the company's limited resources. He assured that the transition out of the trial for patients would be managed safely and in compliance with regulations.
Hepion had previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for rencofilstat in November 2021 and Orphan Drug designation for the treatment of hepatocellular carcinoma (HCC) in June 2022. Rencofilstat is known as a potent inhibitor of cyclophilins, which play a role in various disease processes, and has demonstrated the ability to reduce liver fibrosis and HCC tumor burden in experimental models.
The company has also developed a proprietary Artificial Intelligence deep machine learning (AI/ML) platform to enhance the understanding of disease processes and identify potential responders to rencofilstat. This technology was expected to expedite development timelines and increase the differentiation between placebo and treatment groups.
Despite the setback, Hepion remains committed to exploring strategic alternatives, as it had previously announced in December 2023. The information regarding the wind-down of the ASCEND-NASH trial is based on a press release statement from Hepion Pharmaceuticals.
InvestingPro Insights
Following the announcement of the ASCEND-NASH trial cessation by Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), an in-depth look at the company's financial health and stock performance metrics is critical for investors. According to InvestingPro data, Hepion holds a market capitalization of $9.11 million USD, reflecting its small-cap status in the biopharmaceutical sector. The company's Price to Earnings (P/E) ratio stands at -0.17, indicating that investors are currently not expecting earnings from the company in the near term. This is further underscored by the adjusted P/E ratio for the last twelve months as of Q4 2023, which is -0.2.
InvestingPro Tips suggest that Hepion is quickly burning through its cash reserves and suffers from weak gross profit margins. Moreover, analysts do not anticipate the company will be profitable this year, aligning with a Return on Assets of -124.91% for the same period. These metrics are crucial for investors considering the implications of the halted ASCEND-NASH trial on the company's future prospects. Furthermore, the stock's price performance has seen a significant decline, with a 6-month total return of -53.59% and a 1-year total return of -86.49%, which may raise concerns about the company's ability to recover from the recent setbacks.
Despite these challenges, Hepion's liquid assets exceed its short-term obligations, which may provide some financial buffer in the near term. This is an important consideration for investors monitoring the company's ability to navigate through its current difficulties. For those seeking to delve deeper into Hepion's financial and stock performance, additional InvestingPro Tips are available, providing a more comprehensive analysis. Interested readers can find these tips at InvestingPro and can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enhancing their investment research capabilities.
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