Cerevance adds $47M in funding, will start CVN424 Phase 3 trial
Oral therapy aims to treat early-stage Parkinson's with fewer side effects
After adding $47 million in new funding, Cerevance is planning to launch a Phase 3 clinical trial to test its oral molecule CVN424, designed to treat people with early-stage Parkinson’s disease without the side effects seen with other therapies, the company announced in a press release.
That trial is expected to start in the second half of the year, and will evaluate CVN424 as a single therapy or levodopa add-on.
The new funding adds to the $51 million previously raised, bringing the total Series B-1 financing to $98 million, according to Cerevance. The financing will support the upcoming CVN424 trial, as well as the clinical development of therapeutic candidates for other neurological conditions.
“This upcoming year marks a crucial phase as we embark on the Phase 3 clinical trial for our flagship therapy, CVN424, and continue in discovering innovative, precision [central nervous system] treatments that will enrich our extensive pipeline,” said Craig Thompson, Cerevance’s CEO.
Findings from ongoing CVN424 study will support design of Phase 3 trial
Parkinson’s is caused by the progressive dysfunction and death of dopamine-producing neurons in a brain region called the substantia nigra, which leads to a deficit of dopamine in the striatum, another brain region involved in motor control.  Dopamine is a major brain signaling molecule.
Levodopa and its derivatives are the main medications used for easing Parkinson’s motor symptoms, the hallmarks of which are tremor, rigidity, and slowness of movements. These therapies work by increasing the levels of dopamine in the brain.
However, long-term use of such dopamine-based therapies is linked to several adverse events, or side effects, such as dyskinesia — uncontrolled, involuntary movements — and off time, or periods when symptoms return before the next medication dose.
CVN424 instead does not act on dopaminergic signaling. It is a small molecule that can penetrate the brain and block GPR6, a protein receptor produced by specific neurons in the striatum. These nerve cells, called D2 medium spiny neurons, are involved in the regulation and control of movements.
By reducing GPR6’s activity, the treatment is expected to normalize the activity of these neurons, leading to clinical effects similar to those seen with standard therapies. But it’s also expected that the use of CVN424 may avoid the side effects seen over the long term with levodopa-type treatments.
CVN424 was developed through Cerevance’s proprietary NETSseq platform, which allows the identification of new target proteins specifically involved in the biological pathways affected by a disease, using human brain tissue samples.
A previous Phase 2 clinical trial (NCT04191577) testing CVN424 as an add-on therapy in adults with Parkinson’s treated with levodopa showed the medication significantly reduced off time, by 1.5 hours per day, compared with a placebo. It also increased levodopa’s effects without dyskinesia and reduced daytime sleepiness.
The company now is conducting another Phase 2 trial (NCT060062479) in early Parkinson’s disease in the U.S. Called ASCEND, it’s testing the safety and efficacy of CVN424 as a single therapy, or monotherapy, compared with a placebo, in people with newly diagnosed Parkinson’s who have not yet started on levodopa treatment.
ASCEND is still recruiting patients at sites in several states; top-line data is expected this year.
Findings from this trial will support the design of the Phase 3 trial, which will assess the efficacy of CVN424 in delaying disease progression, and the need for levodopa, in people with early-stage Parkinson’s disease.
Funding partners say CVN424 ‘holds promise’ for treating Parkinson’s
The financing round was led by Agent Capital, Bioluminescence Ventures, and Double Point Ventures, with the participation of the existing investors Gates Frontier, GV (Google Ventures), and Lightstone Ventures. New investors participating are MQB Partners and LifeRock Ventures.
As part of the financing, Campbell Murray, MD, partner at Agent Capital, and Kouki Harasaki, PhD, founder and managing partner at Bioluminescence Ventures, were added to Cerevance’s board of directors.
“We are confident that Cerevance’s lead program, CVN424, holds promise in delivering significant benefits to individuals,” Murray said, noting the “clear need for groundbreaking, innovative therapies for Parkinson’s disease.”
We strongly believe that Cerevance is at the forefront of revolutionizing the research and treatment of [central nervous system] disorders [like Parkinson’s].
Harasaki noted the company’s work in treating diseases of the central nervous system, or CNS, which is comprised of the brain and spinal cord.
“We strongly believe that Cerevance is at the forefront of revolutionizing the research and treatment of CNS disorders,” Harasaki said.
“The remarkable NETSseq platform is accelerating innovation and tangible clinical benefits are emerging from Cerevance’s precision approach to CNS therapies,” Harasaki added.
Cerevance’s pipeline also includes CVN293, a therapy meant to target neuroinflammation in amyotrophic lateral sclerosis, Alzheimer’s disease, and frontotemporal dementia. Topline safety and tolerability data from an ongoing Phase 1 clinical trial are expected this year.
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