Nacutity's new antioxidant therapy has entered clinical trials
2020 05 21
The new anti-oxidation therapy of American anti blindness foundation enters into clinical trials
Nacpharmaceuticals, headquartered in Fort Worth, is conducting phase 1 / 2 clinical trials of npi-001 in Australia. NPI-001 is an oral drug designed to slow down vision loss in retinitis pigmentosa (RP) patients, and RP is related to Usher syndrome. The trial, called slop - RP (safety and efficacy of npi-001 versus placebo in the treatment of retinitis pigmentosa associated with Usher's syndrome), will include at least 48 patients with Usher's syndrome and follow them up for two years. If the outcome of slop-rp is favorable, nacutity plans to conduct npi-001 clinical trials for RP patients in the United States and Australia in 2021.
Through its Rd fund, the foundation has invested $7.5 million in the development of npi-001, a venture philanthropic fund for emerging therapies that are approaching or are undergoing early clinical trials. The foundation also provides scientific advice for the development of clinical trials and therapies. Dr. Benjamin Yerxa, chief executive officer of the foundation, is a member of nacutity's board of directors. Dr. rusty Kelley, vice president of investment of the foundation, is an observer on the board of nacutity.
Halden Conner, chief executive officer and President of nacutity, said: "we are pleased to receive the support and guidance of the foundation to promote our emerging therapies to human research and hope to extend them to patients with retinal diseases who need treatment." "With the foundation as a partner, we are very prepared to achieve the goal of obtaining npi-001 on the terminal line."
Npi-001 is a GMP grade N-acetylcysteine amide (NACA), which is an experimental antioxidant. The researchers believe that in many inherited retinal diseases, increased oxidative stress plays a major role in retinal degeneration and vision loss. The purpose of antioxidant therapy is to reduce oxidative stress.
NACA is related to N-acetylcysteine (NAC), which is an antioxidant therapy approved by FDA for hepatotoxicity caused by acetaminophen overdose. However, npi-001 manufactured by nacutity's patented process has better ability to penetrate and perspective omental cells than NAC.
In the Foundation funded Johns Hopkins University laboratory study, npi-001 reduced oxidative stress and maintained vision.
Nacutity's new therapies are based on very thoughtful and sound science. Since it is an oral tablet, the dosage can be easily adjusted. " Said Dr. Yerxa. "In addition, it was designed to be unrelated to the mutant gene that causes vision loss in patients. This means that npi-001 has the potential to help many people with multiple diseases and genetic characteristics. " |
