Clene has initiated multiple concurrent Phase 2 clinical trials in neurodegenerative diseases with its lead asset, CNM-Au8. These studies are designed to find solutions to the progressive neurologic impairment seen in people suffering from multiple sclerosis, Parkinson’s disease, and ALS. The foundational role of CNM-Au8—as the first therapeutic nanocatalyst— to treat impaired bioenergetics within diseased or damaged cells may also have broad applications in other disease areas.
CNM-Au8 is a concentrated, aqueous suspension of clean surfaced faceted nanocrystalline gold (Au) that acts catalytically to support various intracellular biological reactions. CNM-Au8 consists solely of gold atoms organized into faceted, geometrical crystals held in suspension in sodium bicarbonate buffered, pharmaceutical grade water. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and both remyelination and neuroprotection effects in multiple preclinical studies.
Preclinical studies of CNM-Au8 demonstrated that the drug protects motor neurons from death through a novel nanocatalytic mechanism, increasing the body’s ability to resist several stressors associated with this disease. CNM-Au8 has received regulatory approval to proceed to clinical studies for the treatment of multiple sclerosis remyelination failure and neuroprotection of amyotrophic lateral sclerosis (ALS) and Parkinson’s disease.
CNM-AgZn17 & CNM-PtAu7
CNM-AgZn17, a topical gel polymer suspension of silver and zinc ions, is being developed for treatment of infectious diseases and to accelerate wound healing. CNM-AgZn17 is advancing through IND enabling preclinical toxicology studies and is anticipated to enter human trials in 2020.
CNM-PtAu7 is gold-platinum CSN™ therapeutic. Initial in vitro research has demonstrated broad-spectrum efficacy across a variety of tumor cell lines.