CogniCann, Potential Cannabinoid Therapy, Being Prepared for Europe

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by Lindsey Shapiro, PhD |

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Sciensus Rare, a Dutch healthcare group, was given rights to distribute CogniCann, MGC Pharmaceutical’s cannabinoid-based investigative treatment for people with dementia and Alzheimer’s disease in Europe, should it be approved for commercial use or use in select early access programs.

The agreement stipulates that Sciensus Rare will have four years of exclusive distribution rights for CogniCann in the U.K., Denmark, France, Italy, Spain, and Luxembourg. It also covers distribution rights for CannEpil, MGC Pharma’s potential treatment for drug-resistant epilepsy.

Both treatments are currently in Phase 2 trials. The CogniCann study, taking place at a single Australian site in up to 50 patients, expects to finish by the close of June.

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“We are extremely pleased to be working in partnership with MGC Pharmaceuticals within the exciting global medical cannabis market and look forward to supporting clinicians with access to both CannEpil and CogniCann,” Gareth Williams, president of Sciensus Rare, said in a press release.

Under the agreement’s terms, Sciensus will need to meet a purchase order minimum over the first year to maintain exclusive distribution rights.

MGC Pharma will handle requests for both treatments’ regulatory approval in those countries, while Sciensus Rare will work to make them available to select patients through early access or named patient programs.

“Sciensus Rare is an excellent pharmaceutical service company, with the experience and expertise necessary to increase clinical access for both CannEpil and CogniCann to those patients who are most in need,” said Roby Zomer, managing director and CEO of MGC Pharma.

This agreement, Zomer added, “puts in place a long term plan to build the distribution networks required in Western Europe.”

Alzheimer’s is the most common type of dementia, a group of disorders marked by cognitive symptoms, such as memory loss, confusion, and declining reasoning skills, that interfere with daily life.

Both potential therapies are phytocannabinoids, plant-based chemicals derived from cannabis. Due to their ability to cross the blood-brain barrier and influence the central nervous system (CNS, the brain and spinal cord), these compounds are being considered to treat several neurological disorders.

The blood-brain barrier, a semipermeable membrane that protects the CNS from viruses and other insults that can be carried in the bloodstream, can be a major barrier for the efficient delivery of treatments needing to reach the central nervous system.

Evidence from early studies suggest that phytocannabinoids may be able to ease the behavioral and psychological symptoms of dementia in Alzheimer’s patients, and possibly help to break down the abnormal clumps of the amyloid protein that are associated with disease progression.

Few large, well-controlled clinical trials, however, have evaluated the effects of cannabis or its components on dementia symptoms.

CogniCann is an oral spray that combines two of the most abundant phytocannabinoids in the cannabis plant — tetrahydrocannabinol (THC) and cannabidiol (CBD). The specific ratio of THC to CBD in the blend is designed to improve behavior and cognition in dementia patients, MGC Pharma reported.

The Phase 2 trial of CogniCann, taking place at the University of Notre Dame in Perth, is reported to be a randomized and placebo-controlled, crossover trial in up to 50 people with mild dementia, including that due to Alzheimer’s, ages 65 and over and living in residential care facilities. Its main goals are to evaluate changes in patients’ behavior, quality of life, and pain with treatment.

The COVID-19 pandemic affected this trial, which was reported to have officially opened in 2020 and was initially set to conclude by December 2021.