In June the FDA asked for additional clinical trials to prove safety and mechanism of action.
French firm NicOx is closing its U.S. headquarters effective August 31. The decision follows a review of the company’s structure and requirements after the FDA said it could not approve its lead candidate, naproxcinod. This CINOD (cyclooxygenase-inhibiting nitric oxide-donating) anti-inflammatory was developed for the relief of the signs and symptoms of osteoarthritis.
NicOx shares slid 20%, reaching a 52-week low, on July 23, the day after it received FDA’s feedback. The agency asked that NicOx carry out additional long-term studies to evaluate naproxcinod’s cardiovascular and gastrointestinal risks. The company is also required to conduct trials to demonstrate that the therapeutic benefits of the drug are due to its nitric oxide-donating capabilities.
NicOx plans to discuss possible next steps as early as possible with the FDA. The firm says that it will push on with the European regulatory process and is seeking partnerships for naproxcinod in Europe and the rest of the world. It is also looking to partner other products in its pipeline while pursuing in-licensing and M&A opportunities.
The company reports that cash and cash equivalents as of June 30 were €128.4 million, and there is no long-term debt. NicOx is applying its nitric oxide-donating R&D platform to develop products for the potential treatment of inflammatory, cardio-metabolic, and ophthalmological diseases.
The firm has a collaboration with Bausch & Lomb for the development and commercialization of NCX 116, a nitric oxide-donating prostaglandin F2-alpha analog. The firm has evaluated the compound as a treatment for primary open angle glaucoma or ocular hypertension. NicOx is also working with Merck & Co. to develop nitric oxide-donating antihypertensives and with Grupo Ferrer to develop nitric oxide-donationg anti-inflammatories for the treatment of skin disorders.
