Novartis is stop After looking at the data of kidney transplant patients early, a mid-term clinical trial of a drug to prevent organ rejection showed that the experimental treatment was less effective than standard care treatment.
The Swiss pharmaceutical giant did not disclose specific details about the results of the mid-term study of the drug iscalimab. Novartis said on Friday that it is still reviewing the data, and after the review is complete, it will share the results with the wider scientific community.
Iscalimab is a monoclonal antibody designed to target and block the receptor CD40, which is part of the pathway activated in organ rejection. Novartis once described iscalimab as offering the prospect of “a lifetime transplant.” The company stated in a 2019 report that according to currently available therapies, kidney transplant surgery can last about 10 years, after which patients must be re-treated with dialysis. Investor introductionThe quality of life of these patients is poor, and more than half of them die within five years. Another option is another kidney transplant, which will deplete the donor organ bank. Novartis stated in his speech that Iscalimab can make the transplant operation last for 20 years. The company said that by preventing patients from undergoing a second transplant, the drug will reserve a donor organ bank for new patients.
Novartis released encouraging transplant drug results in 2019, albeit from a small patient sample.according to data Research published at the American Transplant Congress showed that patients treated with iscalimab had better outcomes than patients treated with tacrolimus, an anti-rejection drug used as the standard of care. Of the 5 patients treated with Novartis, 3 showed normal kidney tissue under a microscope, while none of the 7 patients taking tacrolimus found any kidney tissue.
Based on encouraging clinical data, Novartis conducted a phase 2 study enrolling 418 patients. As in previous studies, patients were randomly assigned to receive iscalimab or tacrolimus. In both groups, these therapies were used in combination with other steroids and other immunosuppressive treatments. The main goal is a comprehensive measure of the proportion of patients who reject organs, lose organ function, or die.
Novartis has long believed that iscalimab’s method has potential applications in a variety of immunological indications. Clinical trials for liver transplantation, Sjogren’s syndrome, and hidradenitis suppurativa are ongoing.
Forte Bio’s live biotherapeutics failed to beat placebo in atopic dermatitis
Drugs that can be used to treat itchy and red skin caused by atopic dermatitis include drugs that circulate in the body and suppress the immune system, which may cause a series of side effects in the process. Forte Biosciences aims to avoid these problems with a topical product composed of three strains of Gram-negative bacteria. The company chose this product to solve inflammatory skin diseases. The experimental treatment method FB-401 aims to promote tissue repair and inhibit inflammation. The company also hopes that the drug can inhibit harmful bacteria.
exist preliminary result In the Phase 2 study, Forte stated that, based on a scale that measures the severity of atopic dermatitis, the drug failed to prove statistically significant compared to the main goal of showing at least a 50% improvement. The results showed that 58% of patients taking Forte drugs met this goal, exceeding the 50% mark required to reach the goal. But in the placebo group, 60% of the participants achieved the main goal of the study.
Forte CEO Paul Wagner said in a statement that the company will continue to analyze FB-401 data, but the company will not further advance the development of the drug. He said that updates to the company’s future plans will be released “in the next few months.”
Takeda’s anticancer drug failed to show statistical significance in stage 3
Pevonedistat is a drug of Takeda Pharmaceutical, which is being developed as a first-line treatment for certain blood cancers. Failure Phase 3 clinical trial. This small-molecule drug is designed to block the NEDD8 activating enzyme. This method is designed to trigger cell death by disrupting protein homeostasis in cancer cells.
The Japanese pharmaceutical giant is testing Pevonedistat in combination with the chemotherapy drug azacitidine for the treatment of high-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low-blast acute myeloid leukemia. Compare this combination with azacitidine alone. The main goal is to show an improvement in event-free survival-the amount of time patients remain event-free or complication-free after the end of the main treatment. Takeda stated that the drug did not achieve the statistical significance of the target. The company added that the full results will be presented at a future medical conference.
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