Aptinyx Eyes $80 Million IPO to Advance its NMDA Drug Programs
On Thursday the company filed its S-1 form with the U.S. Securities and Exchange Commission announcing its intention to list its company on the Nasdaq under the ticker symbol APTX. The company, which launched in 2015 as a spinout from Naurex Inc., is looking to raise funds to support its NMDA programs to treat neurological disorders, including depression.
Aptinyx has its lead product, NYX-2925, in two Phase II studies in chronic pain. One study is testing the therapeutic in patients with painful diabetic peripheral neuropathy and the second is for the treatment of fibromyalgia. Aptinyx anticipates topline data from these two studies in the first half of 2019.
In addition to NYX-2925, Aptinyx is studying a second candidate, NYX-783, for the treatment of post-traumatic stress disorder. The company intends to initiate a Phase II trial for this indication later this year. A third product, NYX-458, is a preclinical product, but the company has submitted an Investigational New Drug Application for the U.S. Food and Drug Administration earlier this month. Aptinyx intends to study NYX-458 for the treatment of cognitive impairment associated with Parkinson’s disease.
As of the end of March, Aptinyx had $82.4 million in available funds. The company said those funds are not sufficient enough to take NYX-2925 through Phase III studies. In its note to the SEC Aptinyx pointed to some of the risks for taking a drug into late-stage trials.
“In particular, conducting a Phase III clinical study is a complex process that differs from clinical studies conducted in earlier phases. While some of our employees have conducted Phase III clinical studies in the past while employed at different companies, we, as a company, have not conducted Phase III clinical studies before, and as a result, may require more time and incur greater costs than we anticipated,” the company said in its S-1 filing.
Aptinyx also pointed to its relationship with Allergan as a strength for the young company. Earlier this week Allergan exercised an option to acquire an oral small molecule compound from the company. Allergan secured the small molecule for the low price of $1 million, Aptinyx revealed in its filing. Allergan intends to advance the compound, AGN-241751, for the treatment of major depressive disorder. Allergan has plans for AGN-241751 to become a complementary treatment for another product it gained in the acquisition of Naurex – rapastinel, an intravenously administered NMDA receptor modulating tetrapeptide. Rapastinel is currently in a Phase III trial for major depressive disorder with results expected next year. One year after Allergan acquired Naurex rapastinel received Breakthrough Therapy Designation from the FDA for the treatment of major depressive disorder.