Inflamed Pharma, University Collaborate on ProcCluster

Partnership will target cellular models of the ALS investigational therapy

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by Mary Chapman |

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Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, is partnering with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS).

The collaboration, led by Jan C. Koch, MD, a principal investigator at the university’s Department of Neurology, will be focused particularly on  investigating ProcCluster in cellular models of ALS.

“We are looking forward to working with Jan Koch and his team,” Frank Ploger, Xlife Sciences chief scientific officer, said in a press release. “Together, we hope to lay the scientifically sound, preclinical foundation for a potential drug therapy for the treatment of ALS.”

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ALS is a neurodegenerative disease characterized by the degeneration and death of motor neurons, which are the nerve cells that control voluntary muscle movements. Its exact causes are not fully understood, but nerve cell overactivation is believed to be one of the mechanisms leading to nerve cell death.

ProcCluster is based on the local anesthetic agent procaine, which is able to block voltage-dependent sodium channels that contribute to the overstimulation of nerve cells. By blocking these channels, the compound is believed to reduce nerve cell activation and neuronal damage, slowing the progression of symptoms.

Notably, former procaine formulations could be administered only via injection or infusion. But the new formulation also can be given to patients orally or applied to the skin, both of which are more convenient and preferred methods of administration.

In January 2022, Inflamed Pharma was granted a U.S. patent protecting the novel formulation, which it relies on a “clustering” process in which the active ingredient is incorporated into a protective shell. This technology also may be applied to modify other active ingredients.

Because ProcCluster can block nerve cell overactivation, its properties are similar to riluzole, the first ALS treatment approved in the U.S., now available as a tablet formulation called Rilutek, and oral suspension called Tiglutik, and an oral film formulation sold as Exservan.

However, riluzole is degraded mainly by a liver enzyme, and has been linked to liver damage, particularly when taken alongside other hepatotoxic drugs.

Procaine is broken down not by the liver, but by the enzyme pseudocholinesterase that is produced across cells. So, it has no significant side effects and no interactions with other medicines, according to Xlife.

“ALS is an inexorably progressing and yet incurable disease that can cause great suffering,” said Koch. “Together with inflamed pharma and Xlife Sciences, we are striving to be able to improve the lives of ALS patients and their relatives in the future.”