An unglamorous update...

When I was a practicing cardiologist, launching a clinical trial always seemed to be a huge undertaking. Getting the trial protocol right required understanding all sorts of stuff - the laboratory studies, early clinical testing, the disease being targeted and more, with teams working in parallel at the company, in academic centers and typically within a Contract Research Organization. (As a reminder, a CRO is the operational team that companies big and small use to manage and oversee part or all of the activities in a trial.)

But all of those experiences started after several major tasks were already completed. For example, as a cardiologist I engaged with the FDA as an expert consultant when the company was asking for commercial approval. I did not participate in the early discussions where the FDA was asked for permission to conduct the first trials. Similarly, I got involved after the drug was made and packaged as a capsule or tablet. (After leaving “academic medicine” I had many experiences early in the development process.)

The work for Right Brain Bio is different from my career as a cardiologist. I'm starting from the very beginning - the scientific discoveries. Identifying the drug was an huge step - but then I needed to identify a source from where I could get manufactured drug to use in clinical trials. I thought that using a repurposed drug would mean we could work out a partnership with one of the commercial manufacturers, but of them were willing to work with us. It was clear that to have a reliable supply of drug, we needed to make our own. I've written about that in the past - including the first step of manufacturing the drug substance and determining the recipe to make it into tablets.

This week we took the next step and signed an agreement to manufacture the tablets of RB-190 and matching placebos. Over the next several months, our partner will be making these tablets and then we'll perform tests on the drug product - the tablets - to prove that it is the right chemical and does not have any chemicals we don't want. With confirmation of purity, potency, stability etc., we'll get packages of drug and placebo.

Recently I asked you whether I should consider saving some money and manufacturing only 2 dose strengths, which would require participants in the study to take 4 tablets twice a day. My attempt to provide a questionnaire failed technically, but several of you emailed me to tell me that it would be a mistake to ask people to take 4 tablets twice a day. So we went ahead and committed to manufacture 3 dose strengths so the maximum number of pills would be 2, twice a day.

So now manufacturing is approaching completion, packaging is approaching completion and we're starting to write the IND application (to get FDA permission for the clinical trials).

I know that this is not the most exciting part of this process. I don't get emails asking me about manufacturing; I get emails asking when the trial will start and how people can participate.

When we have FDA permission to start the trial, I'll share information here. When we are getting ready to start, we'll provide a list of investigative sites where the study will be conducted and the characteristics required to participate. Stay tuned.