Failed Studies Shut Down COVID-19 Programs
The decision was made following an interim review of Phase I/II data by an Independent Data Monitoring Committee. The IDMC found Apellis’ APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19, and standard-of-care therapy did not provide a meaningful reduction in the overall mortality rate of patients. The study has been halted and Apellis will not pursue additional development of APL-9, the company said.
Lukas Scheibler, chief innovation officer of Apellis, said the company undertook the investigation because it believed that complement dysregulation might play a key role in disease mortality. APL-9, which uses the same mechanism of action as Apellis’ lead compound, pegcetacoplan (APL-2), was thought to be able to treat COVID-19 and other diseases caused by excessive or uncontrolled activation of complement immune system.
No additional endpoints were analyzed as part of the interim review by the DMC. Enrollment is complete, and the study reached the last patient visit, the company said. Apellis plans to provide full results in a scientific forum following completion of the full data analysis.
“We felt a responsibility to learn if controlling complement could help save lives during this devastating pandemic,” Scheibler said in a statement. “While the mortality results from this study were not what we had hoped, we extend our heartfelt thanks to the patients and their families, healthcare providers, and investigators who joined us in working to address an urgent public health need. We remain confident in the potential of targeting C3 for complement-driven diseases and are committed to bringing transformative treatments to patients.”
Shares of Apellis are down slightly in premarket trading.
In a brief statement, MediciNova said it conducted a careful review of its program and the available resources the company had. Considering the stage of development for its vaccine asset and the expected costs of entering the clinic, as well as the number of vaccines that have already received Emergency Use Authorization and are in late-stage development, the company opted to discontinue its own program. The financial resources and manpower that would have been devoted to the development of a vaccine will now be aimed at the company’s other development programs, which is said “have indications with larger unmet medical needs and market opportunities.”
North Carolina’s Brii Biosciences also announced this week that two antibody programs aimed at COVID-19 generated disappointing clinical results. The company said its antibodies BRII-196 and BRII-198, which were being assessed with hospitalized patients, failed to meet pre-specified efficacy criteria that would allow them to move into the Phase III component of ACTIV-3.
The decision was made following a review from a Data & Safety Monitoring Board. The DSMB determined that pre-specified efficacy criteria in this hospitalized population have not been met, and thus the study will not be expanded to enroll additional patients.
While that study did not generate the hoped-for results, Brii said it was continuing to assess the two antibodies in ambulatory COVID-19 patients through the ongoing ACTIV-2 trial.
“We continue to feel confident in this therapy and its antiviral activity against the newly emerging variants,” Brii Chief Executive Officer Zhi Hong said in a statement.