The Phase Ib trial will assess APL-1401 to treat ulcerative colitis. Credit: KGH / commons.wikimedia.org.

The US Food and Drug Administration (FDA) has granted clearance for Asieris Pharmaceuticals’ Investigational New Drug (IND) application to begin a Phase Ib clinical trial of its oral drug, APL-1401, to treat moderately-to-severely active ulcerative colitis (UC).

Asieris intends to subsequently commence subject enrolment in the trial in the country.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The randomised, double-blind trial will assess the safety, tolerability, pharmacokinetics, and initial efficacy of APL-1401 in such patients.

Asieris Pharmaceuticals chief operation officer Dr John Zhuang said: “As the world’s first oral drug that modulates neurotransmitters to suppress inflammation independently developed by Asieris, APL-1401 will hopefully provide a new treatment for UC patients.

“APL-1401 was born from Asieris’s technology platform for immune regulation. 

“We expect to get safety data and preliminary efficacy signal in this clinical study as soon as possible to support the subsequent clinical development of the product and clinical studies for other indications. 

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

The company also plans to file a CTA application with the National Medical Products Administration (NMPA) of China for the drug soon.

A chronic idiopathic inflammatory bowel disease (IBD) of the colon, UC leads to superficial mucosal inflammation from the rectum to the more proximal colon. 

At present, there exists no treatment for UC.

In June 2019, the company concluded subject enrolment in its Phase Ib clinical trial to assess the safety, tolerability, and PK characteristics of APL-1202 in the US.

APL-1202 is an oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor.

The trial analysed APL-1202 along with intravesical BCG in NMIBC patients.

Clinical Trials Arena Excellence Awards - Nominations Closed

Nominations are now closed for the Clinical Trials Arena Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Science 37 has won the Research and Development Award in the Site Innovation category for its FDA inspected Direct-to-Patient Site model, delivering nationwide access, faster enrollment and higher retention. Explore how its virtual-first, in home approach is reshaping trial operations and accelerating time to data-driven decisions..

Discover the Impact