Creo que en ninguna ocasión, en ninguna … que haya comprado RDUS no las he tenido en rojo antes de verlas en verde ... RDUS 1h … que poca confianza me da cuando se restriegan tanto por una rayuela … >_< ..
NVAX dia esta … me parece que ya esta lista para meneico, eh? .. y viendo el IBB ... ese estocástico nos va a dar la lata pronto … :(
Catalyst Biosciences Receives a Boost with Positive Study Readout
Catalyst Biosciences (CBIO) reported that it has obtained positive results from a Phase 2b clinical trial of its Factor IX therapy. This open label study involved six patients suffering from severe hemophilia B. The daily subcutaneous administration of Dalcinonacog Alfa (DalcA) for 28 days showed more than 12 percent FIX levels with steady state levels up to 27 percent after 14 days. No bleeds were experienced during that time period.
The trial demonstrated effective prophylaxis as well as the potential for lower or less frequent dosing. The Phase 2b study endeavored to evaluate the ability of DalcA for maintaining steady state protective FIX levels above 12% in patients with severe hemophilia B. They were given a single intravenous dose, followed by daily SQ doses of DalcA for 28 days. Patients were thus monitored for pharmacokinetics, pharmacodynamics, safety and tolerability of daily SQ dosing and anti-drug antibody formation.
Nassim Usman, Ph.D., president and chief executive officer of Catalyst, said, “We are very encouraged by the data presented at EAHAD from three of our programs and see 2020 as a pivotal year for our entire hemophilia franchise.” He also added that the company’s SQ FVIIa marzeptacog alfa (activated) MarzAA candidate showed efficacy and safety in individuals with hemophilia A or B with inhibitors in a Phase 2 prophylaxis study.
The study did not detect any anti drug antibodies and there was no report of any serious adverse events. Three patients reported experiencing injection site reactions, the majority of which were resolved without any complications.
Catalyst Biosciences is a clinical stage company and focuses on developing treatments and therapies for rare diseases and systemic complement mediated disorders. Currently, it is working on managing hemophilia and developing subcutaneous systemic complement inhibitors. Its lead drug candidate is MarzAA, which has completed Phase 2 development. During this phase, the treatment met its primary endpoint which was the significant reduction of the annualized bleed rate (ABR) in patients suffering from hemophilia A or B with inhibitors.
Catalyst has achieved various milestones in the recent past, including the presentation of data from Phase 2 of its lead drug candidate MarzAA. The study met its primary endpoint which showed significant reduction of more than 90 percent in the annualized bleed rate in patients suffering from hemophilia A or B. The study also met all its secondary endpoints pertaining the safety, tolerability and absence of ADAs or inhibitor formation.
Catalyst is now continuing with the enrollment for a Phase 1 SQ pharmacokinetic and pharmacodynamic study of MarzAA in individuals with hemophilia A or B (with or without inhibitors). The study aims to provide guidance related to the dose selection for treating a bleed with SQ dosing.
The company's stock has performed steadily throughout the year and the latest news is expected to provide strong positive fillip to its price in the market. Catalyst has entered into a number of new collaborations to fortify its drug portfolio. The company had reported net loss for the third quarter at $12.7 million, up from $7.7 billion it had reported for the corresponding quarter of the previous year. On per share basis, the net loss jumped from $0.64 to $1.06. Its general and administrative expenses for the quarter were $3.3 million, up from $2.8 million, showing 18 percent increase on year-over-year basis.
