Positive feedback
This was a great week. Positive feedback on several parts of the development program.
First, our collaborators in Australia sent back comments on the most recent clinical trial protocol – one updated to allow for an initial data readout to come sooner and thereby tell us and the world whether the value of RB-190 would soar (or that the drug development program would fail). When I opened the file with feedback from three clinical trial experts and saw the extent of questions, comments and recommendations, it felt overwhelming. But when I read each point, I realized that this group of experts was adding incredible value to the protocol and the data it would yield. And it showed a deep level of interest and commitment to this program.
Next, we reviewed 6-month stability data on the preliminary batch of RB-190 – which was very positive. The data show that the RB-190 pills are formulated to the highest standards, critical to know before administering them to people.
And then, I got a response to a draft manuscript I shared with a Parkinson’s expert. The manuscript attempts to explain why more dopamine (levodopa, dopamine agonists etc.) can help people while our dopamine reducing therapy (RB-190) can also help people. That sounds like a contradiction, and for most readers it will be. The short version of our hypothesis: while the brain tissue has less dopamine when Parkinson’s develops, the brain cells that control movement contain too much dopamine that becomes toxic to the very cells that make it — in which case lowering it carefully could protect those cells rather than starve them and possibly restore function.
The first comment in the response, “this is excellent.”
Operational update
We targeted the end of September to submit our request to conduct the clinical trial in Australia. That will be a tough deadline to meet but we are moving towards it. And with the feedback this week, we have even more energy to get this application in tip-top shape. A September (or even early October) submission would make us optimistic that first dosing would be in early 2027 with first data read out later in the year. We'll report our progress here.
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About Jonathan Sackner-Bernstein, MD
Dr. Sackner-Bernstein shares his pursuit of conquering Parkinson's, using expertise developed as Columbia University faculty, FDA senior official, DARPA insider and witness to the toll of PD.
Dr. S-B’s Linkedin page
RightBrainBio, Inc. was incorporated in 2022 to develop tranformative therapies for people with Parkinson's.