Hutchmed meets all endpoints in platelet disorder treatment trial

21st Aug 2023 08:24

(Sharecast News) - Hutchmed China reported a breakthrough from its recent phase three trial in sovleplenib on Monday, reporting that it met its primary endpoint and all secondary endpoints for treating adult patients with primary immune thrombocytopenia - a platelet disorder - (ITP) in China.

The AIM-traded firm said the trial was a randomised, double-blind, placebo-controlled study that involved 188 adult patients diagnosed with primary ITP, who had previously undergone at least one standard line of treatment.

It said the trial aimed to evaluate the effectiveness of sovleplenib against a placebo, and successfully concluded in December last year.

The results demonstrated a clinically significant increase in the durable response rate for patients treated with sovleplenib in comparison to those who received the placebo.

In addition, the trial also confirmed meeting secondary endpoints such as response rate and safety.

The company said the comprehensive results from the trial would soon be presented at an upcoming scientific conference.

Further bolstering the potential of sovleplenib, the National Medical Products Administration of China (NMPA) granted the drug a 'breakthrough therapy' designation (BTD) in January last year.

The designation was based on the drug's potential to address serious conditions for which there were limited effective treatments.

Hutchmed said the BTD also recognised sovleplenib's potential advantages over existing therapies.

As a result, Hutchmed said its new drug application (NDA) for sovleplenib could receive priority review, aiming to expedite its approval for ITP treatment.

The company was planning to submit the NDA by the end of the year.

"Sovleplenib offers a potential new treatment for patients with chronic adult primary ITP who have received at least one prior therapy, a heterogeneous disease that can persist for years and where there remains a significant need for new treatments," said the company's chief medical officer, Dr Michael Shi.

"We are very pleased to see the positive outcomes of the ESLIM-01 study and would like to thank the patients, their families, and the healthcare professionals who participated in this study and helped reach this achievement."

At 0823 BST, shares in Hutchmed China were up 1.53% at 213.73p.

Reporting by Josh White for Sharecast.com.