Oscotec has reported topline data from a Phase II trial of cevidoplenib (SYK inhibitor) in immune thrombocytopenia (ITP) patients who did not respond or relapsed after previous therapy.
The placebo-controlled, randomised Phase II trial was designed to evaluate the pharmacokinetics (PK), safety, pharmacodynamics (PD), tolerability, and efficacy of select cevidoplenib (200mg BID and 400mg BID) doses in ITP patients with <30,000/µL platelet count.
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It was conducted in 61 participants, with a study duration of 20 weeks for each participant.
The trial includes a screening period of up to four weeks, a 12-week treatment period, and a follow-up period of four weeks.
The platelet response rate defined as ≥30,000/µL platelet counts (PLTs) and doubling the baseline is the study’s primary endpoint.
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According to the findings, participants who received treatment with the higher dose (400mg) of cevidoplenib had a 63.6% response rate, compared to 33.3% with the placebo with a 0.151 p-value.
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By GlobalDataThe company stated that 50% of the participants who received the higher dose (400mg) of cevidoplenib achieved two or more consecutive ≥30,000/µL PLTs, compared to 8.3% with the placebo. In addition, 40.9% achieved PLT ≥50,000/µL compared to 8.3% with the placebo in the study’s secondary endpoints.
Oscotec CEO/chief strategy officer Dr Taeyoung Yoon said: “We are elated to see the data that confirms the potential of cevidoplenib becoming a safe and effective medicine for ITP patients who are not responding to the current standard therapies.
“Not only that, the data indicate that our SYK inhibitor will be at least as efficacious as the competitors in late stage development.
“We will explore every available option, including partnership, to deliver our drug as quickly as we can to those who suffers from the potentially crippling disease.”
Furthermore, the company intends to present detailed results from the trial at teh European Hematology Association in June.
