AC Immune SA, of Lausanne, Switzerland, said its small molecule- and antibody-based therapeutic programs targeting the NOD-like receptor protein 3 (NLRP3) inflammasome demonstrated highly potent in vivo anti-inflammatory activity for novel small-molecule NLRP3 inhibitors. The company said it expects to initiate in vivo proof-of-concept studies for a CNS-optimized lead compound for development in Alzheimer’s disease (AD) and other neurodegenerative diseases by year-end, as well as evaluate the potential of a second lead molecule in a clinically relevant non-CNS disease model. The inflammasome is a target implicated in a range of neurodegenerative disorders, including AD, CNS indications such as autoimmune and infectious diseases, as well as certain cancers.
In a new evidence report assessing the comparative clinical effectiveness and value of San Francisco-based Fibrogen Inc.’s roxadustat for treating anemia in chronic kidney disease, the Institute for Clinical and Economic Review (ICER) said that roxadustat represents an oral alternative that may be particularly valuable for those not receiving hemodialysis. However, ICER continued, the pill burden is also a problem for many of those patients and, other than avoiding the need for I.V. iron, there is significant uncertainty about whether roxadustat is safer or more effective than erythropoiesis-stimulating agents (ESAs). “Given prior concerns around cardiovascular risks when ESAs are used to correct anemia, as well as the high baseline risk of such events in people with CKD, this is an important issue to fully evaluate in larger clinical trials,” the report concluded. The report will be reviewed at a virtual public meeting of the California Technology Assessment Forum on Feb. 11.
Moleculin Biotech Inc., of Houston, said it filed to effect a 1-for-6 reverse stock split of its common stock, to take effect Jan. 29. Shares will open for trading on Nasdaq on Feb. 1. Moleculin is developing oncology drugs for treating highly resistant tumors and viruses.
Recordati SpA, of Milan, Italy, said it closed a license and supply agreement with Tolmar International Ltd., of Dublin, to commercialize Eligard (leuprorelin acetate) in Europe, Turkey, Russia and other countries. Eligard is marketed for the treatment of hormone-dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. The product has been commercialized by Astellas Pharma Inc., of Tokyo, in the territories licensed to Recordati, with annual sales in the region of about €100 million (US$121.3 million). Tolmar will manufacture the product for Recordati, while Astellas will provide to Recordati certain transitional services for an agreed period of time. Recordati will make an up-front payment of €35 million to Tolmar, which will also be eligible to receive additional milestone payments up to a total of €105 million as well as royalties on sales.
Rigel Pharmaceuticals Inc., of South San Francisco, said it was awarded $16.5 million by the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support Rigel's ongoing phase III trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients. The company said data from that trial, as well as findings from the NIH-sponsored phase II trial expected to read out in April 2021, could potentially facilitate an emergency use authorization filing in the U.S. Fostamatinib is marketed in the U.S. as Tavalisse (fostamatinib disodium hexahydrate) tablets, and it is approved in the U.S., Europe and Canada as a treatment for adult chronic immune thrombocytopenia.