A study evaluating Curis drug for leukemia is now underway Partial FDA Clinical Suspension The complication was a known dose-limiting toxic effect of the experimental treatment emavusertib after the death of a patient who experienced the complication.
This toxic effect is rhabdomyolysis, in which muscle tissue dies and muscle fibers and other substances are released into the bloodstream, causing damage to the heart and kidneys. This organ damage can be fatal. Curis did not release further details about the deaths of patients in the Phase 1/2a trial, but the Lexington, Massachusetts-based biotech said the FDA requested information about the drug’s safety and efficacy, including information about the drug’s safety and efficacy. Data on Rhabdomyolysis. The agency also asked how the company determined the recommended dose of emavusertib in the second phase of the study.
Emavusertib is a small molecule designed to block interleukin 1 receptor-associated kinase 4 (IRAK4), a protein involved in signaling pathways involved in certain types of cancer and inflammatory diseases. The open-label Phase 1/2 clinical trial of Curis’ drug is a dose-escalation study enrolling patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study was designed to evaluate three doses of emavusertib given to patients as monotherapy or in combination with venetoclax (a standard of care for AML) or azacytidine (a standard of care for MDS).
Partially old means that no new patients can participate in the study. However, patients currently benefiting from treatment in the study may continue to receive the drug at doses of 300 mg twice daily or lower — 300 mg being the median of the three doses evaluated in the study.
Another Phase 1/2 study is evaluating emavusertib in patients with lymphoma. At the end of 2020, Curris Preliminary data reported This showed tumor reductions in six of the seven non-Hodgkin’s lymphoma patients treated with the 300 mg dose. These patients had previously received a median of fourth-line cancer therapy. At the time, Curis recommended that the Phase 2 portion of the clinical trial test a dose of 300 mg twice a day. The company said the dose balances durable anticancer activity with prolonged tolerability.
While the lymphoma clinical trial is not affected by the partial leukemia drug hold, Curis said the company has decided to suspend the registration until the leukemia research partial hold is resolved.
“We are committed to ensuring patient safety in our studies and working with the FDA to develop therapies that can meaningfully improve and prolong patients’ lives,” Curis Chief Executive James Dentzer said in a prepared statement. “Given the clinical profile of emavusertib observed to date, we hope to resume the study as soon as possible after appropriate review. We continue to be confident that emavusertib addresses the high unmet needs of patients with AML or MDS.”
Curis is one of several companies developing cancer drugs that target IRAK4. Competitors include Emmaus Life Sciences, Kurome Therapeutics, Kymera Therapeutics and Rigel Pharmaceuticals. Curis has an FDA-approved drug, the chemotherapy Erivedge. The product is marketed by Roche subsidiary Genentech under a licensing agreement that pays Curis royalties on drug sales.
Shares of Curis fell more than 33 percent on Monday to close at $1.62.
Photos by Flickr users K-State Research and Promotion through Creative Commons license
