Sobi orphan drugs are used for chemotherapy-induced plate plateboard reduction phase III clinical failure.

Swiss orphan drugmaker Swedish Orphan Biovitrum (Sobi) recently published the main results of a phase III clinical study of the oral platelet-producing agent Doptelet® (avatrombopag) for chemotherapy-induced platelet reduction (CIT) in solid tumor patients.
Although avatrombopag increased plateplate counts compared to placebos, the study did not reach the primary compound endpoint of avoiding plate plate plate infusion, reducing chemotherapy dose by 15% or more, and delaying chemotherapy dose by 4 days or more.
company's share price plunged 17 per cent on the day of the failed research.
The randomized, double-blind, placebo-controlled Phase 3 clinical study was designed to assess the efficacy and safety of avatrombopag for ovatrombopag for ovarian, lung (small and non-small cell carcinoma) and CIT after chemotherapy in patients with bladder cancer.
study included 122 patients who developed 3/4 LEVEL CIT after the last A-level chemotherapy cycle, and the trial randomly divided the subjects into avatrombopag or placebo.
the ultimate goal of preventing plate plate infusion, the initial dose of plate plate plate infusion needs to be evaluated.
the main endpoint of the compound is the effect of avatrombopag increasing plateplate counting, thus preventing CIT patients from needing plate plate plate infusion or chemotherapy dose reduction or delay.
secondary endpoint is security.
results showed that 69.5 per cent and 72.5 per cent of the participants who received avatrombopag and placebo were considered to be the primary endpoint respondents (p-0.72) in the intended treatment population (full analysis data set).
in the pre-programmed population, 85.0 per cent and 84.4 per cent of the participants who received avatrombopag and placebo were considered to be the primary endpoint respondents ( p -0.96), respectively.
the study showed an "accidental" placebo response.
sobi noted that, surprisingly, the rate of dose delay and dose reduction was so low in placebo subjects.
is currently conducting additional data analysis to understand this observation.
secondary endpoint, in cancer patients receiving bone marrow-inhibiting chemotherapy, the adverse event data for avatrombopag were comparable to that of placebo, highlighting its safety.
is a potentially serious complication of chemotherapy that can lead to low plate plate plate levels and can lead to reduced doses of chemotherapy, delayed doses of chemotherapy, or changes in chemotherapy programmes.
currently in the United States or the European Union, there is no approved CIT treatment.
Doptelet is an oral TPO-subjected agitant that is not dietaryly restricted.
Doptelet has received FDA and European EMA approval to treat CIT (low platelet count) patients with chronic liver disease (CLD) who undergo surgery under the program.
June 2019, the FDA approved Doptelet for the treatment of platelet reduction in adult patients with chronic immunodeficiability (ITP) who have not responded to previous treatments.
chronic ITP is a rare autoimmune hemorrhagic disease characterized by a small number of plate plates, and avatrombopag has been designated as an orphan drug for chemotherapy-induced CIT in the United States.
Sobi's acquisition of Dova Pharmaceuticals in 2019 in a $915 million deal and its ambitious inclusion of Doptelet in its portfolio.
analysts at Jefferies said at the end of September that the release of the data would be a "key event" for Sobi, and experts believe the third phase is likely to be a success, but the reality is unexpected.
source: 1. Sobi announces topline phase 3 data of avatrombopag for the treatment of the treatment of Technology-Induced Thrombocytopenia 2.Sobi's Dopteletes miss key goal of the processy-induced thrombocytopenia trial.