Chemomab Therapeutics Releases Encouraging Results from OLE Phase 2 Spring Trial for Nebokitug in Primary Sclerosing Cholangitis
On Thursday, Chemomab Therapeutics Ltd. (CMMB) announced the outcomes from the Open Label Extension (OLE) phase of the Phase 2 Spring trial for its investigational drug nebokitug in treating primary sclerosing cholangitis (PSC). This trial extension aimed to evaluate the long-term safety, tolerability, and efficacy of nebokitug in patients who had previously completed the initial 12-week treatment period.
Background on Primary Sclerosing Cholangitis and Current Treatment Landscape
Primary sclerosing cholangitis (PSC) is a chronic, progressive, and often debilitating liver disease that affects approximately 1 in 1,000 people. The condition is characterized by inflammation and fibrosis in the bile ducts, leading to bile buildup and damage to the liver. Currently, there are no approved therapies for the underlying disease, and treatment focuses on managing symptoms and preventing complications such as liver failure, cirrhosis, and liver transplantation.
Results from the OLE Phase 2 Spring Trial
In the OLE portion of the Phase 2 Spring trial, 25 patients received nebokitug at a dose of 1 mg/kg weekly for up to 52 weeks. The primary endpoint was the percentage of patients with a composite endpoint of worsening cholestatic liver injury, defined as an increase in alkaline phosphatase (ALP) levels by ≥30% and a total bilirubin ≥3 mg/dL. The trial showed that no patient met the composite endpoint during the OLE period.
Additionally, the trial demonstrated that nebokitug was generally well-tolerated, with no new safety concerns identified. The most common adverse events were fatigue, pruritus, and nausea, which were mild to moderate in severity.
Impact on Individuals with PSC
For individuals with PSC, these results offer hope for a potential new treatment option. Nebokitug’s ability to prevent worsening cholestatic liver injury in the OLE phase of the trial is a significant finding, as it could potentially slow down the progression of the disease and improve quality of life for patients.
Global Implications
If approved, nebokitug could represent a major breakthrough in the treatment of primary sclerosing cholangitis. Given the lack of approved therapies for the underlying disease, a new treatment option could significantly impact the lives of the estimated 100,000 people living with PSC worldwide. Additionally, the development of nebokitug could incentivize further research into the underlying mechanisms of PSC and potentially lead to the discovery of additional treatment options.
Conclusion
The encouraging results from the OLE phase of the Phase 2 Spring trial for nebokitug in treating primary sclerosing cholangitis offer a glimmer of hope for patients and their families. While more research is needed before nebokitug can be approved as a treatment, these findings represent an important step forward in the quest to develop effective therapies for this debilitating condition. If ultimately approved, nebokitug could significantly impact the lives of the approximately 100,000 people living with PSC worldwide, and potentially pave the way for further advancements in the understanding and treatment of this disease.
- Chemomab Therapeutics Ltd. (CMMB) announced results from the OLE phase of the Phase 2 Spring trial for nebokitug in PSC.
- No patient met the composite endpoint of worsening cholestatic liver injury during the OLE period.
- Nebokitug was generally well-tolerated, with mild to moderate adverse events.
- Individuals with PSC may benefit from a potential new treatment option.
- Global implications include the potential to significantly impact the lives of the estimated 100,000 people living with PSC worldwide and incentivize further research into the underlying mechanisms of the disease.
