TEL AVIV - Chemomab Therapeutics Ltd. (NASDAQ:CMMB), a biotechnology firm, reported positive results from a Phase 2 trial of its drug CM-101 for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease. The study met its primary endpoint of safety and tolerability and showed significant improvements in liver stiffness, a marker of disease progression, after 15 weeks of treatment.
CM-101, a monoclonal antibody, demonstrated anti-fibrotic, anti-inflammatory, and anti-cholestatic effects in the trial. The drug also led to improvements in pruritis (itchiness) and total bilirubin levels, which are indicators of liver health. These results suggest that CM-101 has the potential to modify the course of PSC, a disease with no approved treatments that can lead to liver failure and death.
The trial, named SPRING, was a double-blind, placebo-controlled study involving 76 patients across the U.S., Europe, and Israel. Participants received CM-101 or a placebo every three weeks over 15 weeks. The study's results were particularly significant in patients with moderate to advanced disease, who showed greater improvements in several disease-related biomarkers.
Chemomab plans to engage with the U.S. Food and Drug Administration (FDA) for an end-of-Phase 2 meeting and discuss the design of a Phase 3 trial, aiming for accelerated approval. The company expects to complete discussions by the end of the year and initiate the Phase 3 trial in 2025.
An Open-Label Extension (OLE) of the SPRING trial is ongoing, allowing patients to receive CM-101 for an additional 33 weeks. Topline results from the OLE are anticipated in the first quarter of 2025.
The information in this article is based on a press release.
In other recent news, Chemomab Therapeutics Ltd. has released findings that strengthen the link between the protein CCL24 and the severity of primary sclerosing cholangitis (PSC), a rare liver disease. The study, which utilized machine learning to analyze proteomic profiles from PSC patient samples, suggests that higher levels of CCL24 correlate with disease severity and cirrhosis.
Furthermore, Chemomab has recently completed patient enrollment for a Phase 2 trial in primary sclerosing cholangitis, with results expected by mid-2024.
In other developments, Chemomab has been granted an extension by Nasdaq to meet the exchange's minimum bid price requirement by November 4, 2024. The company has also secured a new patent from the European Patent Office for its monoclonal antibody CM-101, further strengthening its intellectual property portfolio.
These are among the recent developments at Chemomab Therapeutics Ltd.
InvestingPro Insights
Chemomab Therapeutics Ltd. (NASDAQ:CMMB) has recently delivered promising news regarding its CM-101 drug trial, which is a beacon of hope for patients with primary sclerosing cholangitis (PSC). As investors digest this information, it's important to consider the financial health and performance metrics of the company, which can be found on InvestingPro's platform.
InvestingPro Data shows a market capitalization of $20.19 million USD, indicating the size of the company in the biotechnology market. Despite the potential of CM-101, the company's P/E Ratio stands at -0.91, reflecting its current lack of profitability. Furthermore, the Price / Book ratio as of the last twelve months is 1.51, which can offer insights into how the market values the company's net assets.
Among the InvestingPro Tips, two stand out for their relevance to the current article:
1. Chemomab holds more cash than debt on its balance sheet, which is a positive sign for investors looking at the company's financial stability as it continues to develop CM-101.
2. The company is quickly burning through cash, a critical factor for investors to monitor, considering the costs associated with advancing clinical trials and seeking FDA approval.
For investors interested in a deeper dive into Chemomab Therapeutics' financials and performance metrics, there are additional InvestingPro Tips available. Readers can explore these insights by visiting https://www.investing.com/pro/CMMB and can benefit from up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription using the coupon code PRONEWS24. Currently, there are 12 more InvestingPro Tips available, which could provide valuable context to Chemomab's financial health and stock performance.
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