At the start of October, Swedish-based IRLAB announced that the FDA approved an investigational new drug application (IND) for their therapeutic candidate mesdopetam (IRL790). This therapy is designed to treat patients with Parkinson’s disease, particularly those struggling with levodopa-induced dyskinesias.
Currently, researchers are exploring Mesdopetam as a potential therapy for patients with Parkinson’s-associated dyskinesias. Levodopa is a drug designed to provide patients with dopamine, thus reducing tremors and other movement-related symptoms. However, many patients develop levodopa-induced dyskinesias. The Parkinson’s Foundation describes this as:
a side effect that causes involuntary rapid jerking and twisting, or slow and extended muscle spasms. The severity of these side effects can range from bothersome to incapacitating.
So IRLAB developed mesdopetam as a way to improve quality of life (QOL) and reduce dyskinesia symptoms. In prior clinical trials, mesdopetam, in conjunction with other Parkinson’s disease medications, reduced involuntary movements and improved motor function. Now, IRLAB submitted the now-accepted IND to continue moving forward with testing.
As described by the FDA:
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement, [and] the IND is the means through which the sponsor technically obtains this exemption.
Because the IND was accepted, IRLAB can now include American and European patients in the upcoming Phase IIb and Phase III clinical trials to test the safety, efficacy, and tolerability of mesdopetam.
Caused by dopaminergic neuron death, Parkinson’s disease is a progressive central nervous system (CNS) disorder which impedes movement. Dopamine helps transmit messages between the brain and muscles. So when dopaminergic neurons die or are damaged, motor function is decreased. Researchers are not sure exactly what causes this death, but it has been linked to toxin exposure and genetics.
Generally, Parkinson’s disease occurs in five stages. During the first two stages, symptoms progress from light tremors on one side of the body to tremors and muscle rigidity on both sides of the body. Balance is lost by stage three, and patients can no longer live independently by stage four. In the final stage, patients have difficulty walking and standing, and may experience hallucinations. Typically, Parkinson’s disease onset does not occur until after 50 years old. Symptoms include:
- Muscle stiffness and rigidity
- Tremors in the hands
- Amnesia or confusion
- Slowed movement
- Changes in posture or balance
- Slurring, stuttering, or other speech alterations
- Sleep disturbances
- Loss of smell
- Depression and anxiety
- Rhythmic muscle contractions
Learn more about Parkinson’s.