Clene Awaits US Patent Covering Gold Nanocrystals’ Use in Treating MS

Clene Nanomedicine has been notified it will be given a U.S. patent, as requested, covering an invention using the company’s already patented gold nanocrystals for the treatment of multiple sclerosis (MS).

A Notice of Allowance was received by the company. These notices are issued by the U.S. Patent and Trademark Office (USPTO) to indicate an examiner has determined an application merits the requested patent being issued.

According to Clene, its gold nanocrystals are free from organic impurities on their surfaces, which makes them “clean” relative to surfaces of gold nanoparticles made via other processes. The USPTO allowance discloses that these gold nanocrystals can be suspended in water and can be taken by mouth by, for instance, an MS patient.

“As the leading developer of clean surfaced nanocrystal therapeutics for humans, we continue to expand our patent estate and are pleased to receive this latest Notice of Allowance from the USPTO,” Rob Etherington, president and CEO of Clene, said in a press release.

Clene is currently developing CNM-Au8 as a potential gold nanocrystal-based therapy for MS, as well as for people with Parkinson’s disease and amyotrophic lateral sclerosis (ALS).

The therapy is designed to promote chemical reactions that cells use to generate energy, while helping to remove the destructive byproducts of cellular metabolism. This is expected to help protect neurons, as well as aid in the generation of myelin — the fatty sheath around neuronal axons that is targeted by the immune system in MS. Preclinical work was reported to show “robust” myelin generation in animal and cell models of MS.

The mechanism of action of CNM-Au8 is distinct from current MS treatments, immunomodulators that alter the activity of the immune system.

“While the only approved treatments for MS today are immunomodulators, we see an opportunity to treat MS through a completely different mechanism of action utilizing the therapeutic bioenergetic effects of catalytic gold nanocrystals, such as CNM-Au8,” Etherington said.

“This Notice of Allowance comes as we are conducting two Phase 2 studies of our lead drug candidate CNM-Au8 in the treatment of MS,” Etherington added.

Clene is sponsoring two ongoing Phase 2 clinical trials evaluating CNM-Au8 in people with relapsing MS, which includes relapsing-remitting and secondary progressive disease: REPAIR-MS (NCT03993171) and VISIONARY-MS (NCT03536559).

REPAIR-MS is evaluating how the investigational therapy moves through and is processed by the body — its pharmacokinetics and pharmacodynamics — as well as its safety and tolerability. The trial may still be recruiting up to 30 adults at its Dallas, Texas, site; contact information is available here.

Additional data from REPAIR-MS are expected later this year, according to Clene.

VISIONARY-MS is evaluating CNM-Au8 in people with MS lesions that affect vision, a common MS symptom.

Early trial results, presented last year, were positive, indicating improvements in vision, as well as better gait, limb function, and cognitive ability. The trial, which is expected to complete enrollment this year, is recruiting at several locations in the U.S., Canada, and Australia. Additional information is available here.