Arno Therapeutics Is Shuttering Its Doors
Arno Therapeutics is calling it quits. It sold off all its assets, with the final asset being the rights to Onapristone, which it sold to Context Biopharma.
Onapristone is a type 1 anti-progestin hormone blocker for the treatment of breast, endometrial and other solid tumors in post-menopausal women and advanced castration-resistant prostate cancer in men. In late March, the company announced plans to deregister its common stock. On Jan. 4, 2017, the board of directors announced they were evaluating all potential development and strategic opportunities involving its product candidates to conserve its cash and other resources. The deregistration eliminated legal, accounting and other administrative expenses.
Arno had licensed Onapristone from Invivis Pharmaceuticals in 2012. It had originally been developed by Schering AG, currently a unit of Bayer. Schering abandoned the drug after Phase II trials in breast cancer had liver toxicity issues. It was being developed as a possible contraceptive. Arno licensed it under the plan that it could be formulated as an extended release version and partnered with Leica Biosystems to develop a companion diagnostic for APR+ patients.
In a Phase I trial in 2014, the drug failed to show much efficacy, although its safety, which was the primary purpose of the trial, was reasonable. Seeking Alpha reported in January 2016, “People clearly thought the results were disappointing as the stock dropped significantly to new lows. However, the main purpose of the study was to evaluate toxicity. No liver toxicity related to the drug were noted, but three patients experienced grade 3 liver function abnormalities, which were deemed by independent safety review committee as not drug related. In terms of anti-tumor activity, these results do not really say much without knowing the cohort makeup of gynecological and breast cancer.”
In January 2017, the company announced it wasn’t going to enroll three remaining patients in its Phase II trial. The company’s stock, already battered, fell another 22 percent. The trial was of onapristone in combination with abiraterone acetate in men with advanced castration-resistant prostate cancer (CRPC) who had unsuccessfully been treated with abiraterone acetate alone.
ThePharmaLetter wrote, “There were hopes that the combination of onapristone and abiraterone acetate, which is sold under the brand name Zytiga by subsidiaries of the U.S. health care giant Johnson & Johnson would provide a potential new treatment for men with prostate cancer and a significant opportunity for Arno.”
But the data wasn’t convincing anyone that the drug was all that effective and the company was losing money by the minute. The company didn’t think the data on the first 12 patients warranted adding three more patients.
In today’s announcement, the company stated, “The sale of Onapristone assets was part of a plan of liquidation and dissolution approved by both the board of directors of Arno and by the holders of approximately 67 percent of Arno’s outstanding common stock pursuant to a written consent. Prior to the end of 2017, Arno intends to file a certificate of dissolution with the Delaware Secretary of State and to satisfy or otherwise resolve its remaining liabilities from the proceeds from the sale of the Onapristone assets and its remaining cash reserves. The company intends to maintain a small cash reserve to fund wind-down expenses.”
The company is withholding about $200,000 to cover any wind-down expenses. If there’s any left, which the company thinks is unlikely, it will be given to the company’s former chief executive officer, who had agreed to cut his original obligation by 20 percent.