U-NEURON initiates Phase I clinical trial enrollment for UA002, pioneering amniotic stem cell therapy for erectile dysfunctionApr 11, 2024

U-NEURON Biomedical Inc.  announced on the 10th that its amniotic stem cell therapy UA002 has officially begun Phase I clinical trials, targeting patients with erectile dysfunction caused by diabetes and prostatectomy. The first patient has already been enrolled. This trial is planned to continue recruiting participants at two hospitals in the northern region, with a total of 9 to 15 subjects. Upon completion of the trial, applications will be submitted for multinational Phase II clinical trials in Taiwan and the United States, followed by international licensing negotiations. 

U-NEURON is a regenerative medicine company that pioneered the isolation and cultivation of amniotic stem cells from human umbilical cords. Leveraging the properties of amniotic stem cells, the company has developed regenerative therapies for neurological, inflammatory, and degenerative diseases, as well as a series of new drugs and medical beauty products. UA002 marks the company's first product to enter clinical trials and is the only amniotic stem cell therapy aimed at promoting nerve regeneration and repair. If approved, it could benefit male patients worldwide. 

Shiaw-Min Hwang, General Manager of U-NEURON, stated that UA002 has demonstrated potential in treating erectile dysfunction in animal disease models conducted by the Fu Jen Catholic University team. With approval from the Taiwan Food and Drug Administration (TFDA), the enrollment of the first patient represents a significant milestone in the field of amniotic stem cell therapy. UA002 is not only the first product from U-NEURON to enter clinical trials but also the first amniotic stem cell product to undergo clinical trials in Taiwan. If its potential effects are confirmed, multinational multicenter clinical trials will continue in Taiwan and the United States, paving the way for international licensing negotiations. 

U-NEURON pointed out that erectile dysfunction (ED) is a common issue among middle-aged and older men. According to medical papers published in the Asia-Pacific region, the prevalence rate among men over 40 is over 25%. There is a significant unmet medical need. According to Market Research Future (MRFR), the global market for erectile dysfunction drugs is estimated to reach approximately $29 billion by 2025. 

Currently available treatments for erectile dysfunction only provide temporary relief and come with various limitations. Ideal therapies are lacking for patients who have undergone prostatectomy due to prostate cancer or those with diabetes-related erectile dysfunction who are unresponsive to vasodilator therapy. 

Compared to other sources of mesenchymal stem cells, amniotic stem cells have superior proliferative and differentiation abilities. If successfully marketed, they could offer a more ideal treatment option for patients with sexual dysfunction, significantly improving their quality of life. 

In addition to UA002, U-NEURON also has UB003, which uses amniotic stem cell exosomes as raw materials to treat severe dry eye syndrome. Shiaw-Min Hwang stated that since enrollment for dry eye syndrome is progressing rapidly, formulation development will be pursued before planning clinical trials, positioning U-NEURON as a leading regenerative medicine company in Asia. 

Resource (Mandarin): 

永立榮 UA002 展開臨床一期收案 創羊水幹細胞新藥首例