Nicox’s Partner Fera Pharmaceuticals to Investigate Naproxcinod as Potential COVID-19 Adjuvant Treatment

Nicox and Fera Pharmaceuticals announced that Fera will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection. Subject to successful completion of the ongoing manufacturing of naproxcinod test material, Fera plans to initiate preclinical proof-of-concept studies in models of COVID-19 infection in early 2021.

Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO and naproxen, originally discovered and developed by Nicox.  Nicox and Fera entered into an agreement in December 2015 that granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market.  Nicox and Fera are amending their existing agreement to include COVID-19 as an indication, and Nicox will grant to Fera warrants¹ to acquire 10,000 Nicox shares.

“There is a strongscientific rationale for using naproxcinod in the treatment of the inflammatory symptoms of COVID-19 infections, and potentially against the virus itself,” Michele Garufi, Chief Executive Officer and Chairman of Nicox, said in a company news release. “In collaboration with Fera we will be testing this scientific rationale in relevant preclinical models and whilst this research is at an early stage, any potential future human trial would benefit from the extensive naproxcinod clinical data previously generated by Nicox for the treatment of signs and symptoms of osteoarthritis.”

Rationale for naproxcinod in COVID-19 treatment

Most outcomes of COVID-19 are associated with high levels of inflammation and dysfunction of the vascular system leading to thrombotic events.² Naproxcinod, a Cox-Inhibiting Nitric Oxide Donor (CINOD), would potentially treat multiple aspects of COVID-19 infection including fever, pain, inflammation and platelet aggregation, thus decreasing the risk of thrombus formation. In addition, NO donation might increase vasodilation and restore normal vascular functions. Moreover, NO has specifically been demonstrated to inhibit replication of the COVID-19 virus by two distinct mechanisms.³ As an oral capsule formulation, naproxcinod could be easily administered to patients at the first signs of infection.

Once Fera has received the newly manufactured naproxcinod, they plan to initiate proof-of-concept preclinical tests in models of COVID-19 infection. Should the results of these studies prove positive, Fera plans to meet with the FDA)to identify the clinical trials that would be required to submit a new drug application (NDA) for naproxcinod in the treatment of COVID-19 infection. 

Under the terms of the naproxcinod agreement with Nicox, Fera is responsible for all clinical development, manufacturing, regulatory and commercialization activities in the U.S. Nicox retains all rights to naproxcinod outside the U.S., subject to the payment of royalties to Fera, if intellectual property developed under the agreement is used outside the U.S.

Fera continues to review non-COVID-19 development options for naproxcinod, including addressing the FDA refusal letter concerning Fera’s application for Orphan Drug Designation (ODD) of naproxcinod in sickle-cell disease.