SOM3355: An «old» drug showing positive effect on psychiatric and motor symptoms in HD patients

SOMBiotech is a company based in Europe that tests drugs for new purposes, so-called re-purposing. A medicine that has been used for another condition (mild hypertension) for several decades, now named SOM3355 has been tested in 129 Huntington patients. Recently SOMbiotech published very interesting news about the results and the dialogue they have had with both the European Medicines Agency (EMA) and the Federal Drug Administration (FDA). EMA and FDA are responsible for approving new therapies. They also guide and work with companies ahead of an approval about what kind of information to collect during a trial and also what kind of analyses that might be guiding the approval evaluation.  

Originally SOMBiotech expected SOM3355 to have a positive effect on motor symptoms (chorea) for HD patients. It looks like it does more than that. In depth analysis shows that there are also positive effects on psychiatric symptoms.  

In Europe there are few options available when it comes to treating involuntary movements. The most known is Tetrabenazine. This is a very old drug, and the effect can be limited in many patients. The biggest concern is that it can have serious negative side effects, like depression and suicidal thoughts.  

SOM3355 works differently. In the trial people with HD who took SOM3355:

  • Showed a significant reduction in involuntary movements.
  • Reported less anxiety and depression.
  • Did not experience common side effects like excessive sleepiness.

 

It is also very good news that there seems to be very little or no negative side effects. 

What’s Next

SOM Biotech plans to start the final Phase 3 clinical trial in late 2026.

  • The study will include people with mild to severe Huntington’s disease.
  • Participants will take either SOM3355 or a placebo (a pill with no active drug) for three months.
  • After that, they can choose to stay in the study for another nine months,(open label extension) receiving the actual treatment to check for long-term benefits.
 

If this final trial is successful, SOM3355 could become the first drug approved to address both movement and psychiatric symptoms of Huntington’s disease.

What the Company Says

“This is an exciting step toward giving patients a better, safer option (...) The FDA’s support means we can move forward quickly with the final stage of testing.”
Silvia Panigone
CEO of SOM Biotech
“The fact that SOM3355 may help with depression, anxiety, and movement problems—without causing sleepiness—is something we’ve never seen before."
Dr. Rossella Medori
Chief Medical Officer

Find More Information

● Read the full press release here.

● Learn more about SOM3355 here.

– Article written by Astri Arnesen and Dina de Sousa