30/12/2023
Dear all,
this is my first post ever. We will share it with all of you on the usual multimedia channels and our webpage
It has a personal component as well as background of the company I founded back in 2014 in California: HFM - Hybrid Fusion Medicals which has also developed two products against Chronic Covid - PTX111 and SB1 coming to the market now.
The personal issues first: I had two very severe accidents in May 23 and another one in October 23. I was in hospitals and had to undergo surgery. In addition, my brain was injured as well and I had to stop working altogether and undergoing also for some period rehabilitation. That’s why we have been delayed to bring out the products earlier. Fortunately, the teams of HFM have continued to work on efficiently their own and we are now finally launching both products against Chronic Covid.
Now to the facts and news for you:
All of our products are very different from what exists. Our target is always that our products are best and first in class. Unless we have solid reason to believe that we will be able to achieve this, we even don’t start with a development program.
Both of our anti-Covid drugs are very unique and are based on what we call Humanized Fusion Molecules. This means that those substances contained in our products have been used in the human evolution in different forms for thousands of years in various traditional medical systems primarily in periods of high civilization in different continents. This means a very large body of data based on medical history as well as more than thousand publications on the different aspects of the drugs- pre-clinically as well as clinically in a broad range of indications. This goes far beyond Covid, both acute and chronic.
Production is ongoing and in fact geared up as fast as we can because we expect very substantial demand and ordering. Please refer to the specific guidelines how to order and all related issues on our website: hybridfusionmedicals.com - How to order: Hybrid Fusion Medicals
We also do have other late-stage clinical drugs in the field of Chronic Hepatitis B, Lymphedema (swelling of the arm after surgery and radiation in cancer) primarily in breast cancer as well as products against diseases of the Central Nervous System like Parkinson's and Alzheimer's.
We could finalize also the submission with health authorities in the US (FDA) and Europe (EMA) for market authorizations in most of our key markets including Switzerland and India.
This is a major milestone for us being a small company, but now with a global reach out.
We are excited that we now can serve patients with Chronic Covid, adults as well as children and adolescent- which is very important to us. We expect the drug PTX to have also efficacy comparable to vaccines. This is why we call them also VLPs (Vaccine Like Pharmaceuticals). However, this remains to be validated in clinical trials.
We are confident that our products will also be helpful in new pandemics to come up as expected by most experts.
We now have a silent pandemic of 250 million people globally, according to latest estimates, who are suffering from a chronic and long-lasting form of Covid-19. Leading experts believe that not only Chronic Covid will be with us for decades.
We will use different distribution and marketing channels in parallel. First of all, our own web shop. In addition, established channels to pharmacies and the medical community.
With regard to pricing, we will first choose a moderate approach for the non-prescription version of our drugs. The prescription versions need authorization by FDA, EMA, BfArm and Swissmedic as well as a specialized ministry in India. We have been in intense discussion with some of them for a prolonged period of time.
In any case the non-prescription version will be on the markets now.
We have applied for global patent coverage for the treatment of acute and chronic Covid. This will give us some level of protection against competitors having not spent blood, sweat and tears and enormous amounts of money to get us where we are.
We are in the final stage of planning very large clinical trials comparable to phase IV in the normal drug development sequence.
This is the best way to address Chronic Covid with its many sub-groups which we try to categorize by phenotyping (classifying patients according to their symptoms) and also with molecular markers differentiating the different sub-groups. We are in final discussions at present with leaders in Chronic Covid which parameters they recommend to be integrated into our trial programs. We will publish the final selection on our website and multimedia. Of course also specifically the medical community.
These clinical trial programs shall have thousands of patients. This is of course a huge task but we have professional partners who can manage such huge clinical trials in a way that we can serve patients best according to their requirements. It is almost like in cancer: Every patient is different and has different pharmacological and molecular requirements.
We try to address this also by our second-generation products against Covid in the making. The target is to provide certain sub-groups with different molecules and modify their quantities depending on molecular and clinical characteristics. This is beyond the medical state of the art as of now.
All of this of course needs large amounts of development expenses and so we plan to go for an IPO on NASDAQ in Q2 2024. In the meantime, we hope for large scale sales to enable us to address those huge tasks ahead.
We know it is visionary but based upon a very practical medical experience of all of us for the last decades. What we are doing is ground breaking, but doable especially when we are able to attract the best talent from around the globe into our teams. This is why you will find also on various multimedia channels our search for highly skilled experts.
Finally, we are at present addressing issues of reimbursement by health insurance companies and are interacting with the Social Supreme Court in Germany. The Court has issued groundbreaking rules in favor of patients with diseases with only limited or no treatment options at all. We will communicate the results of the ongoing interactions with the Court to all of you asap.
We do not want that patients who are anyway suffering from a very difficult to treat disease are also burdened financially.
That’s all for today. We will keep you informed by further posts and podcasts on our website and the usual multimedia channels on further news and facts. We therefore suggest you visit our webpage frequently and our social media channels. We wish you all the best and hope for your collaboration.
It was not our intention to share this post during the festive season. However, we wish all of you a Merry Christmas. To those of you with chronic Covid, we wish you that you improve in 2024 and hope to contribute with our medicines SB1 and PTX111.
Best
Chris
Christoph von Keudell, M.D. Ph.D.
CEO and Chairman
Hybrid Fusion Medicals GmbH
CH- 4410 Basel - Liestal
info@hybridfusionmedicals.com
www.hybridfusionmedicals.com
"ln the beginning l looked around but could not find the car l dreamt about; this is why l decided to build it for myself." Prof.lng, h.c. Ferdinand Porsche
