PANGYO, South Korea, Feb. 24, 2023 /PRNewswire/ -- Oscotec Inc. announced topline results for Phase 2 trial evaluating the efficacy, safety and tolerability of cevidoplenib (SYK inhibitor) in immune thrombocytopenia (ITP) patients who have failed to respond or relapsed after prior therapy.
Cevidoplenib was evaluated in a 61-participant randomized, placebo-controlled trial to access its efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of select (200 mg BID and 400 mg BID) doses in ITP patients with a platelet count <30,000/µL. The study duration was 20 weeks per subject, which consists of up to 4 weeks of screening period, 12 weeks of treatment period, and 4 weeks of follow-up period.
Primary endpoint of this study is the platelet response rate defined as platelet counts (PLTs) ≥30,000/µL and doubling the baseline. The response rate for the participants who were treated with cevidoplenib at the higher dose (400 mg) was 63.6% compared to 33.3% on placebo with p-value of 0.151. In the secondary endpoints, 50.0% of the participants on the higher dose (400 mg) achieved 2 or more consecutive PLTs of ≥30,000/µL compared to 8.3% on placebo (p = 0.015) and 40.9% achieved PLT ≥50,000/µL vs. 8.3% on placebo (p = 0.055). It should be noted that these secondary endpoints were more comparable to the ones used as the primary endpoints in the clinical trials of the competitors.
Oscotec is planning to present detailed results at European Hematology Association in June.
"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." said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. "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."
About Immune Thrombocytopenia (ITP)
Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets. Formerly known as idiopathic thrombocytopenic purpura, ITP can cause purple bruises, as well as tiny reddish-purple dots that look like a rash. The prevalence (how many have ITP at any time) is 9.5 per 100,000. ITP patients experience chronic fatigue. The most concerning, but rare, form of bleeding due to ITP is an intracranial hemorrhage (bleeding in the brain). ITP treatment consists of the administration of corticosteroids, immunoglobulins, thrombopoietin receptor agonists, etc. However, sustained remission in the absence of treatment suggests the optimization of ITP management is necessary.
About Oscotec Inc.
Oscotec is a clinical stage drug discovery and development company and focus on discovering small molecules with a novel mechanism of action and validating the drug-target-disease hypothesis through rigorous science into clinical proof-of-concept. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also a originator of lazertinib, a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers.
Contacts
Jihyun Park, IR/PR
jhpark@oscotec.co.kr
June Hahn, BD
junehahn@oscotec.co.kr
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