In April, 2019, EIP Pharma announced that they had funded a program to explore the use of neflamapimod as a treatment for DLB. Phase 2 clinical studies are expected to start this year. Ongoing Phase 2 studies trials with early Alzheimer's are expected to provide results in early fall. The drug inhibits an enzyme involved in a process that appears to increase nerve inflammation and turn a natural protein, alpha-synuclein, into toxic Lewy bodies.
Even if this new drug shows promise, it is still a long way from being available for use. Phase 2 trials can last up to two years and only about a third of experimental drugs pass these tests. In addition, drugs may undergo more than one Phase 2 trial. So far, neflamapimod has had four. Each phase of a clinical trial takes about 2 years, but as with the trials of neflamapimod for Alzheimer's, there can be more than one in each phase which may or may not run concurrently.
Netflamapimod has been in Phase 2 clinical trials for use with Alzheimer's since 2015. The four Phase 2 trials brought about enough positive reports to instigate Phase 2 trials for other diseases, including DLB, to start in 2019. If everything goes perfectly, it may be ready for FDA approval in five years--in about 2024. (2 more years for the new Phase 2 tests and 3 years for Phase 3).
FDA approval can be a long drawn out process taking 2-3 years. The FDA has been fast tracking drugs to treat serious conditions like dementia. The skipped steps do decrease the assurance of a drugs effectiveness but it can shorten the approval process by many months. Our experience is that most people living with LBD and their families would be willing to accept that danger so as to be able to try the drug sooner.
However, once the drug is on the market, it still won't be easy to get. Doctors may also hesitate to prescribe them until Phase 4 clinical trials, which occur after a drug is on the market, are complete. These Phase 4 trials test new drugs that are in public use for any problems that might have been missed in the previous trials. Even if your doctor is willing to prescribe it, insurance companies provide limited coverage for new drugs that are usually a lot more expensive than existing drugs to start with.
For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff
Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.
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