The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.
On the basis of these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgAN by itself in the United States and through collaborations in other regions.
The results indicate that Nefecon was generally well-tolerated and were consistent with the known safety profile of Budesonide. The number of withdrawals in the trial was significantly less than what was seen in the Phase 2b NEFIGAN trial.
Meiling Ming, Hongjun Long, Zhicheng Ye, Changtian Pan, Jiali Chen, Rong Tian, Congrui Sun, Yongsong Xue, Yingxiao Zhang, Jiaming Li, Yiping Qi, Jun Wu, Highly efficient CRISPR systems for loss-of-function and gain-of-function research in pear calli, Horticulture Research, Volume 9, 2022, uhac148,
The cotyledons of tomato (Lycopersicon esculentum L., cv. Jia Fen-10) seedlings were induced to produce calli and regenerate plants via organogenesis. Utilizing this system, the composition and content of stage-specific proteins associated with organogenesis were analyzed. Moreover, a comparison of the protein composition and content between embryogenic and nonembryogenic calli was conducted. The SDS-PAGE results and laser densitometric scanning maps showed that there were different specific proteins expressed at different stages. Among them, six proteins (61, 54, 38, 37, 35, and 23 kD) were associated with the morphogenesis of organs, and two proteins (39 and 24 kD) were related to the morphogenesis of calli. Although no distinctive difference in protein components of embryogenic calli was noted, there were different trends of changes, both for the content of the proteins 39 and 24 kD, and for the content of the total proteins, at different developmental stages of embryogenic calli. The results obtained from the embryogenic and nonembryogenic calli indicated that these two materials were distinct in the protein components as well as in its content; for example, the protein 54 kD was detected in nonembryogenic but not in embryogenic calli. The total protein content in nonembryogenic calli was lower than that in the embryogenic calli. 781b155fdc