Partnership to advance Infudopa SubC drug-device combination
Neuraxpharm, Dizlin team up on wearable device for advanced Parkinson’s
Neuraxpharm is partnering with Dizlin Pharmaceuticals on Dizlin’s Infudopa SubC drug-device combination therapy, which allows for continuous levodopa-carbidopa delivery in people with advanced Parkinson’s disease.
Infudopa SubC is a wearable device being developed for patients who experience fluctuations in their Parkinson’s motor symptoms despite treatment.
“Our partnership with Dizlin is a powerful step [toward] reshaping the future of Parkinson’s care,” Jörg-Thomas Dierks, MD, CEO of Neuraxpharm, said in a company press release. “This collaboration reflects our unwavering mission to bring forward differentiated, breakthrough solutions for people living with [central nervous system] disorders.”
In a Phase 1 clinical trial (NCT03419806), the drug-device combination demonstrated similar efficacy to an approved but more invasive therapy. Infudopa SubC was developed by Dizlin to deliver a combination of levodopa and carbidopa — a mainstay treatment for Parkinson’s — throughout the day rather than in discrete doses. The aim is to even out the fluctuations in motor symptoms experienced by some patients.
A progressive disease, Parkinson’s is caused by the death of nerve cells that produce the chemical signaling molecule dopamine. Dopamine is important for voluntary movement, so the loss of these neurons can trigger tremor, difficulty moving, and other motor symptoms. Nonmotor symptoms, including depression and anxiety, are also common.
Drug-device combination allows continuous levodopa-carbidopa delivery
Levodopa aims to increase dopamine in the brain by providing a precursor molecule that cells can use to make dopamine. It is generally considered the gold standard of Parkinson’s therapy.
Some medications combine levodopa with another medication known as carbidopa. This prevents cells outside the brain from using levodopa, ultimately resulting in more of it being available to brain cells.
Over time, however, levodopa and related medications can lose their efficacy. This increases so-called off time, during which symptom management is not optimal and motor function may worsen.
To address these motor fluctuations, pumps have been developed that deliver medications continuously via under-the-skin (subcutaneous) injections. In 2024, the U.S. Food and Drug Administration approved Vyalev (foscarbidopa and foslevodopa), which subcutaneously delivers precursors of carbidopa and levodopa.
With Infudopa SubC, Dizlin and Neuraxpharm aim to create a similar drug-device combination, but with levodopa plus carbidopa rather than precursors.
“Infudopa SubC is more than a therapy — it’s a life-changing solution, effectively and practically delivering treatment to PD [Parkinson’s disease] patients,” Dierks said.
We are committed to bringing our products to market quickly — and confident of being successful in this regard — so that more patients in the advanced stage of Parkinson’s disease can gain access to this possibility of enhancing their life quality and functioning.
Dizlin also developed Infudopa IntraV, a liquid form of levodopa and carbidopa given intravenously, or through a vein. It’s meant for hospital patients who can’t take levodopa by mouth or through a feeding tube, such as before or after surgery.
The Phase 1 trial compared both Infudopa SubC and Infudopa IntraV to Duopa (sold as Duodopa outside the U.S.), a levodopa plus carbidopa formulation injected surgically into the small intestine. A total of 18 participants received all three treatments at different times, allowing for direct comparisons. The researchers examined the effects on motor symptoms and the treatment’s pharmacokinetics, or how the drugs move through the body.
After an hour and a half of infusion, each therapy had significantly reduced motor symptoms, such as slowed movement, known as bradykinesia, and involuntary movement, called dyskinesia. But a pharmacokinetic analysis showed that both Infudopa therapies resulted in higher levels of carbidopa in the blood compared with Duopa, indicating better uptake. The three therapies resulted in similar levodopa levels in the blood, and Infudopa SubC matched the speed of Duopa in delivering levodopa.
Infudopa SubC designed to be easier to use than other devices
While the results were largely similar between Infudopa SubC and Duopa, the subcutaneous injection option is less invasive and does not require hospitalization. According to Neuraxpharm, this may offer people with advanced Parkinson’s greater flexibility and independence.
Further, Infudopa SubC can be stored in a refrigerator for as long as three years, or at room temperature for at least three months. This may make it easier for patients to manage, especially when traveling, the release noted.
Björn Velin, Dizlin’s CEO, said the company is “very pleased” to have partnered with Neuraxpharm to advance its drug-device combination treatment.
“We are committed to bringing our products to market quickly — and confident of being successful in this regard — so that more patients in the advanced stage of Parkinson’s disease can gain access to this possibility of enhancing their life quality and functioning,” Velin said.
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