A biopharma that uses gold to develop treatments for neurodegenerative diseases just got a little bit richer.
Clene Nanomedicine pulled in $42.5 million in a Series D financing round Wednesday, money which will go toward advancing its lead program through a Phase III platform trial in ALS and support Phase II trials in MS, Parkinsons disease and ALS. CEO Rob Etherington said that by the end of 2021, Clene will know whether or not the candidate, called CNM-Au8, will prove effective.
It will take us to the end of all these clinical endpoints, Etherington told Endpoints News. The exciting thing for us is that one asset could potentially be indicated to improve neurological function in MS, as well as ALS, and [though] Parkinsons is the slower program, this money is going to help us launch more completely that program.
CNM-Au8 is a liquid suspension of gold nanocrystals that catalyze intracellular biological reactions. Such catalyzation can lead to improvement in nerve cell survival, function, and communication. Chemically, the clean surfaces of the nanocrystals help normalize ATP production in cells, which is lacking in serious neurological diseases like ALS, CMO Robert Glanzman said.
Were providing bioenergy support to cells, Glanzman said. Theres a reason why we tend to get neurodegenerative diseases as we get older, and that is because as we age, theres a linear loss of bioenergetic capacity within neurons and what were doing is actually providing these neurons and other cells with free energy, essentially.
In terms of visible symptoms, Glanzman added that patients taking CNM-Au8 will see better strength, muscle mass and be able to speak, breathe and swallow more easily over a longer period of time.
Clenes Phase III study comes as it was selected to participate in the first-ever platform trial for ALS, which enrolled its first patients earlier this month. The trial compares three separate treatments for the disease, with UCBs zilucoplan and Biohavens verdiperstat joining CNM-Au8 at Harvard-backed Massachusetts General Hospital in testing 480 total patients.
Though delayed from a March start due to the Covid-19 pandemic, the platform trial aims to expedite the development of therapies for a disease that advances rapidly and that has few effective treatment options. Only riluzole, also known as Rilutek and OKed in 1995, shows any measurable effect on ALS patients, Etherington said.
Riluzole, which functionally is really the only drug that most people with ALS use, was originally approved to delay the need for tracheostomies to encourage breathing for an extra couple months, Etherington said. But it has a very modest effect generally. It is the standard of care, however, because its the only really markedly relevant drug thats been approved for ALS in this country. Theres a few others but most of them do very little.
Clene has two other programs in the pipeline, though neither have reached the clinic just yet. The first is a topical gel containing silver and zinc ions, with researchers looking at burn treatment, accelerated wound-healing and as an anti-infective. Theres also a gold-platinum therapeutic being studied for use in oncology, which is still in the initial in vitro stage.
The bottom line for Clene though is that finding a treatment option for the extremely difficult ALS indication becomes closer to reality, with a potentially huge impact on the field.
The way you and I move and can grasp things and can talk, all this fine motor movement we take for granted, Etherington said. An ALS patient loses these and this is exactly what we are studying.
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