Today, March 27, 2025, Chemomab Therapeutics issued a press release announcing results from the Open Label Extension (OLE) section of the SPRING trial, which offered SPRING participants the opportunity to receive nebokitug (CM-101) for an additional 33 weeks (up to 48 weeks of exposure to nebokitug).
PSC Partners is encouraged by the positive nebokitug OLE data shared in the press release.
Key takeaways from the press release that are important to patients:
More than 90% of the eligible study patients elected to join the OLE.
The OLE data offers a very favorable safety and tolerability profile of nebokitug in PSC.
The OLE data provides evidence of stabilization of liver function tests and fibroscan and the reduction of serum bile acid levels.
Reductions in markers of liver fibrosis (ELF and PRO-C3 tests) are a positive signal that nebokitug may have an impact on clinical outcomes, particularly for those with more advanced disease (fibrosis stages 2 and 3). The design of the previously announced Phase 3 study includes time to first clinical outcome as a primary endpoint* and will enhance for those with advanced disease.
Overall, between these favorable OLE results and the previously announced enrollment criteria for the planned Phase 3 Study (see notice here) a wider range of patients will be included in this study, and patients with more advanced disease will be a key priority. The full press release is available on the Chemomab website.
PSC drug development has been challenging. PSC Partners encourages patients to remain engaged and respond to requests to make our voices heard and our priorities known.
To ensure that new therapies complete their full course of clinical development, please engage in the numerous opportunities PSC Partners offers for you to share your experience and perspective. We will continue to open new doors to bring patient perspectives to the foreground. With your help, we will support enrollment into these studies to prevent delays in completing research that can lead to the approval of effective drugs.
To stay directly informed about study opportunities and to advance PSC research, please join the Patient Registry.
*Primary endpoint: The single most important outcome that researchers measure to determine whether a new treatment is effective.
A Phase 3 trial is the final phase of clinical trials before the Food and Drug Administration (FDA) conducts a review to determine whether to approve the drug for market. An overview of the phases of clinical trials can be found here (source FDA).
PSC Partners will continue to update the community as more information becomes available regarding this study. Please check back for updates, including on the Registry’s Ongoing Clinical Trials page.
For more information regarding CM-101:
Previous news article: Phase 3 Trial Announcement from Chemomab for Nebokitug (CM-101) in PSC
Previous news article: Chemomab Announces CM-101 Phase 2 SPRING Trial Results
More results from the open-label extension of the SPRING trial are expected in the first quarter of 2025.
Two scientific publications related to CM-101 are available in the Related Publications page of the Registry’s Clinical Trials section.