Oscotec reports positive results from cevidoplenib phase 2 trial in ITP

Oscotec has reported positive results from the phase 2 clinical trial of its SYK inhibitor cevidoplenib in patients with immune thrombocytopenia (ITP) who did not respond or relapsed after prior therapy.

As per the South Korean-based clinical-stage pharma company, cevidoplenib has been studied in a randomized, placebo-controlled trial that featured 61 participants.

The mid-stage clinical trial evaluated the SYK inhibitor’s safety, efficacy, tolerability, pharmacokinetics (PK) as well as pharmacodynamics (PD) in select dosages of 200mg twice-daily and 400mg twice-daily in immune thrombocytopenia patients who have a platelet count of less than 30,000/uL.

Its duration was 20 weeks for each subject. This included up to four weeks of screening as well as 12 weeks of the treatment period, and four weeks of follow-up.

The primary endpoint in the immune thrombocytopenia clinical trial is the response rate of platelets, defined as the number of platelets (PLTs) at or above 30,000/uL and more than double the baseline.

The response rate for patients treated with cevidoplenib at the greater dosage of 400mg was 63.6 percent, as compared to 33.3 percent on placebo, with a p-value of 0.151.

Oscotec said in the secondary endpoints, 50 percent of patients taking the higher dose of 400mg had two or more consecutive PLTs of more than or equal to 30,000/uL, in comparison to 8.3 percent for placebo and 40.9 percent of them achieved PLTs greater than or equal to 50,000/uL, in comparison to 8.3 percent for the placebo arm.

It has to be noted that the secondary outcomes were comparable to ones that were the primary endpoints in the clinical studies conducted by competitors, said Oscotec.

Dr. Taeyoung Yoon — Oscotec CEO/CSO 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. With the proven, exceptional safety profile and the convenience of oral dosing, we believe that cevidoplenib could one day become a genuinely competitive drug of choice for patients with ITP.

“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.”