The new drug clinical study application of APL-1401 for the treatment of moderately to severely active ulcerative colitis was approved by the US FDA

Global innovative pharmaceutical company Yahong Pharmaceutical (stock code: 688176.
SH) announced on November 10 that its clinical application (IND) for its oral drug APL-1401 for the treatment of moderately to severely active ulcerative colitis has been approved
by the U.
S.
Food and Drug Administration (FDA).
The company will initiate clinical enrollment in the United States as soon as possible and submit a clinical study application
to the National Medical Products Administration (NMPA) of China in the near future.

The study is a phase Ib randomized, double-blind study
evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderately to severely active ulcerative colitis.

Ulcerative colitis (UC) is a chronic idiopathic inflammatory bowel disease (IBD) of the colon that extends continuously from the rectum to the proximal colon, causing varying degrees of superficial mucosal inflammation
.
The overall incidence and prevalence of UC were reported from 2000 to 2011 from 1.
2 to 20.
3 per 100,000 person-years and 7.
6 to 245 per 100,000 person-years
, respectively.
The annual incidence of UC ranges from 8.
8 to 23.
1 per 100,000 person-years in North America and 0.
6 to 24.
3 per 100,000 person-years in ^Europe1
.
The incidence of UC in China showed an increasing trend, about 1.
45-2.
0/100,000 ^{person-years2}
.

Inflammation in UC can lead to ongoing bowel damage, increasing the risk of
hospitalization, surgery, and colorectal cancer.
The main goals of treatment for UC are to improve quality of life, induce and maintain clinical remission, achieve steroid-free remission, and minimize cancer risk
.
There is currently no cure for UC, and the clinical needs of UC patients remain unmet
.

"We are pleased that APL-1401 has been approved
by the US FDA for the treatment of UC's IND.
APL-1401 is the world's first oral therapeutic drug independently developed by Asia Pharma to modulate neurotransmitters and thus inhibit inflammation, which is expected to provide new therapeutic methods
for UC patients.
Dr.
Zhuang Chengfeng, Chief Operating Officer of Yahong Pharma, said, "APL-1401 comes from Yahong's immunomodulatory technology platform
.
We look forward to obtaining an initial proof of concept as soon as possible in this clinical study to support subsequent clinical development of the product and clinical studies
for other indications.
" Ahong's efforts will continue to explore cutting-edge technologies for innovative treatment mechanisms to address urgent medical needs and provide patients with more treatment options
.
"

       1.
Gajendran M, Loganathan P, Jimenez G, et al.
A comprehensive review and updat on ulcerative colitis.
Disease-a-Month.
2019; 11: 53.

2.
Yan Pengguang, Li Jingnan.
Standardized diagnosis and treatment of ulcerative colitis[J].
Chinese Journal of Internal Medicine, 2021, 60(6):4.