A – Thomas Meyer: The first question is about our betahistine program. Who are the competitors? Why do you think AM-125 is going to be a success in the U.S. market? The competitive landscape is different between the U.S. and the rest of the world, when it comes to the dizziness treatments. In the U.S., dizziness or vertigo today is treated primarily with vestibular depressants like meclizine or benzodiazepines, which are generic drugs. They typically sedate patients to deal with immediate symptoms like nausea or vomiting. However, they should not be taken for more than three days since they tend to suppress vestibular compensation and healing. These drugs are also known in the rest of the world, but one important difference that is there oral betahistine is available as another treatment option.
Actually, this is considered the standard of care in most of these markets. Annual sales of oral betahistine are currently about $450 million. Unlike the vestibular suppressants, betahistine does not sedate patients. It actually increases alertness and enhances vestibular compensation. There are two major players today in the oral betahistine market, which are a Viatris in Europe, Canada and Australia and Abbott (ph) in probably more than 100 countries around the world. With AM-125, we have a formulation for intranasal application, which has a much higher bioavailability than oral betahistine as mentioned. Based on this, we expect AM-125 to help grow the market and to take share from oral betahistine in the rest of the world. Now for the U.S., we see the lack of oral betahistine as a great opportunity since doctors, neurologists, ENT physicians and others, they clearly see the need for non-sedating vertigo treatments that support vestibular compensation rather than suppress it.
It’s very unusual that a drug that is so frequently used worldwide is not on the market in the U.S. We expect the AM-125 to fill this important gap in the U.S. market. The next questions are about RNA activities, and they will be answered by Dr. Paneda. The first one is, if your platforms are truly exceptional, how come that you still need to make a lot of efforts to make it known? Cova, please.
Covadonga Paneda: The field of RNA therapeutics in constant evolution and drug and biotech companies are continuously assessing different technologies to ascertain the best option to deliver their RNA-based drugs. Up to now, the field has been extremely focused on lipid nanoparticles or as they are known, LNP and for good reason, the progress achieved with LNP has been spectacular. The technology is very powerful. However, this technology has also limitations, especially when it comes to delivering RNA to target tissues beyond the liver and regarding the release of the RNA cargo within target cells. Given the good performance for liver delivery, a lot of efforts have been made to modify LNPs in a way that they reach also elusive non-hepatic tissue.
Success has been rather limited so far. And in addition, there are quite a few intellectual property issues that come with this technology. Therefore, pharma and biotech companies have started to explore alternatives. I think that we’ve made great efforts and progress within a relative short period of time to increase the visibility of our technology with them, and especially also beyond scientific circles. We are very pleased that we have been invited to more and more industry symposia conferences to present our technology. The most recent example is our participation in the RNA therapeutics and delivery conference in Berlin, where we are moderating a panel on the future of RNA therapeutics outside the liver and sharing a session on RNA formulation strategy.
In parallel to increasing our visibility, we have been engaging in a growing number of business development discussions with biotech and pharma company. So these discussions, we can draw on and show potential partners a large and growing amount of data. The Heqet collaboration has been just the start. Based on our growing pipeline of leads, we expect to enter into more collaboration as we move forward.
