$LBPS was originally $LOAC which was a SPAC that merged on March 17th, 2021 it merged with 4D Pharma: Leaders in Live Biotherapeutic Products (LBPs) to Revolutionize Treatments for Numerous Medical Conditions. Now the trick with this SPAC is not play the merger and get out early. This SPAC is all about the PRODUCT HITTING THE MARKET and gaining traction in the treatments of Inflammatory Bowel Disease, Irritable Bowel Syndrome – constipation, diarrhea, or mixed (Also known as IBS-C, IBS-D, or IBS-M for short), along with central nervous system diseases like multiple sclerosis, Alzheimer’s and Parkinson’s disease, epilepsy and stroke. Also any gastrointestinal disease that tract from mouth to the anus. Finally, the money maker being there ONCOLOGY partnership with Merck and Keytruda! Let us do a deep dive into recent RNS, Events, and Presentations.
UPDATE – 1/27/2022
4D has release an RNS filing on their Phase 2a Asthma data. The data looks great and are highly encouraging. This trail enrolled 34 patients which only showed 2 possible adverse effects and no serious adverse effects. The Asthma Control Questionnaire baseline was destroyed by 4D. Most importantly at the end of treatment, 50% of patients experienced reductions in the use of their inhalers! Snippet of RNS below.
4D is currently in process of enrolling up to 90 patients for Phase 2b which is expecting to release data in late 2022. This trial will test its efficacy on a larger group of participants. This is knocking on the door of a $1-2B market sector. 4D market cap is around $150M!
UPDATE – 3/23/2022
4D has release an RNS filing on their Keytruda + MRX0518 treatment combination! It has passed its Phase 2b primary efficacy endpoint of “3 out of 30 patients showing clinical benefit.” The treatment is safe for its users as well! Call at 10am EST today to further discuss the data and the future of the partnership with Merck and Ketruda. This is knocking on the door of a multi billion dollar market sector and US stock LBPS is up over 50% premarket. You can view the RNS here. Snippet of RNS below.
A few highlights is that this company provides their form of treatment in pills that are manufacture in-house. This is an important fact, pills are easily consumed by people of all ages. 4D Pharma has also manufactured a single strain LBP known as Blautia Hydrogenotrophica with a patent coverage out to 2036. There are four patent families including granted patents in the US, Europe, and Japan. 4D is also a sector-leading patent portfolio with over 65 patent families and over 1000 granted patents in the LBP space.
How is 4D different from their competitors and what have they changed? Well issues in the development of novel drugs are as follows:
- High failure rate due to safety & tolerability
- Complexity of Manufacturing
Well their new MicroRx platform and clinical programmes allows for faster development, safe & tolerability treatment for its users, and a simple and reliable way to manufacture these pills. Their MicroRx platform is the idea of using the bacteria found in your large intestines to aid in treatments. Their scientists have done extensive research on the bacteria found in these areas like Blautia Hydrogenotrophica or Blautix for short. MicroRx has generated clinical candidates in oncology, respiratory and gastrointestinal disease.
The four key highlights for 4D is their pioneering of a new therapeutic class, validated unique discovery platform – MicroRx, harnessing bacterial functionality in high-impact disease areas, and a strong corporate position as a leading innovator in LBP space. They are in the perfect position to expand their horizon and start to attack other health conditions by using LBPs. Additional capital will be raised for 4D when the merger occurs on 3/14/2020
Along with the treatment of IBS, 4D has tested and noticed anti-tumor activity in multiple syngeneic mouse models with their partner Keytruda, a company that works with your immune system to help fight cancer cells. MicroRx also has the potential to unpick the Gut-Brain Axis. 4D will continue to use their new form of LBP treatment to target multiple sclerosis, which has observed initial positive signs already, followed by attacking depression, autism, and anxiety (along with other CNS conditions).
Important Company Infrastructure
Lets not forget that 4D also has the power and infrastructure already to continue testing and manufacturing all new treatments in house.
4D Pharma has goals of tapping into the sectors of respiratory conditions, neurodegenerative diseases, irritable bowel syndrome (IBS), and immuno-oncology. 4D is the leader in LBPs and the applications for this new form of treatment is limitless. As an athlete and personal health nut I always like to let the human body do its work. We aren’t the most complex species on this planet for no reason. The human body is an amazing organism and the idea of using its bacteria in higher doses to target health conditions could turn out to be the next step in medical treatment.
Oncology & Collaboration with Merck
As you can see from the image below the treatment for IBS is just a small part of what 4D is working on. We need to concentrate on 4D’s development in LBPs with Merck. Merck is one of the largest pharmaceutical company’s having a product list with names starting with every letter of the alphabet. They where founded in 1891 and some of their most notable medical treatments is Keytruda which is used to treat certain types of breast cancer, skin cancer, colorectal cancer, and a few other forms of cancer. Another treatment they have developed is Januvia which is used to treat Type 2 Diabetes and generated $5.52B in revenues in 2019. Merck is not some small start up pharmaceutical firm. They are a welly know established company who have recognized the significance of 4D’s new treatments using LBPs.
Specifically 4D and Merck will be using LBPs to treat conditions in the department of oncology. Through the MicroRx program they have developed a immuno-oncology therapeutic titled MRx0518. This is a TLR5 agonist, that as both a monotherapy and in combination with an immune checkpoint inhibitor, is a safe and well tolerated modulator of the tumor microenvironment. In combination with the Keytruda study there is clinical proof-of-concept in difficult to treat, highly refractory patients. There is a 42% clinical benefit, exceeding predefined threshold of 10% and no increase in immune-related adverse events.
In the neoadjuvant monotherapy study with MRx0518 has demonstrated potent immuno-modulatory activity, significant impact on tumor microenvironment and no treatment related adverse effects. MRx0518 has also been shown to increase immune cell populations associated with anti-tumor response. Below you can see a few test results from the treatment of MRx0518.
Yes, the previous data about Blautix in treating IBS looks very promising. That is just a stepping stone for 4D and its stock price. The partnership between 4D, Merck, and the use of MRx0518 is what is going to drive this stock price. Merck has seen and recognized the ability 4D has shown in their new forms of LBPs. Together they will be a force to reckoned with and bring new treatments in the area of oncology.
Blautix and Testing
4D Pharma’s main target at the moment is using Blautix to aid in the treatment of IBS-C, IBS-D, and IBS-M (Irritable Bowel Syndrome – constipation, diarrhea, or mixed). They conducted an 8 week research test which administered 2 capsules twice a day with patients having both IBS-C and IBS-D. There where 353 patients randomized. 158 have IBS-C and 195 have IBS-D. About 60% of all IBS patients worldwide are female so in this study about 75% of the 353 patients where female.
Here we will look at their data from their 8-week tests. The main target was to aid in reducing constipation in IBS-C patients and reduce the amount of diarrhea in IBS-D patients. Also, another important test result is the reduction of pain in the test subjects. All data is compared to Placebo. Which is basically a control group that had a substance with no therapeutic effect of IBS-C or IBS-D. This acts as the baseline of patients with IBS-C or IBS-D but given no treatment.
The graph you see above is the total testing results. Here IBS-C and IBS-D are grouped together. In the test there was an overall response rate of 6.6%. Improvement in bowel habit of 13.1% and an improvement in less abdominal pain of 6.5%. Something worth noting is that this one pill has worked for both IBS-C and IBS-D. I have previously mentioned the condition of IBS-M where an individual has a fluctuation between constipation and diarrhea. There is currently no medical treatment for this condition and right here 4D has provided successful data from one pill that can treat IBS-M!
Now we can just look at the improvement here in IBS-C. This group had 158 test subjects with 76 patients receiving Blautix. Their was an overall response rate of 7.9% with a 14.1% improvement in bowel habit and a 7.2% improvement in less abdominal pain.
Lastly, the graph above shows the results for IBS-D patients. Here 195 patients where tested and only 94 where given the Blautix treatment. An overall response rate of 5.6% with a 12.2% improvement in bowel habit and a 6.0% improvement in less abdominal pain.
So is it safe?
With all medication, there can be side effects and potential adverse events (AEs). Here 4D Pharma reported no difference in AEs compared to the placebo treatment. In fact placebo registered a 33% chance of AEs and Blautix registered a 32.8% chance of AEs. So their is no additional harm to the patients taking the treatment.
What does the market look like for this treatment?
Well in 2019 their where about 1.7 million cases of IBS-C treated. At the time the leading blockbuster IBS-C therapeutic was Linacoltide. Unfortunately, many patients would stop the use of their treatment do to a significant increase in AEs like diarrhea and pain with the use of their medication.
Also in 2019 an estimated 1.4 million cases of IBS-D where treated. The leading medication at the time was from a company called Rifaximin. The treatment was a form of antibiotic to attempt to stop the diarrhea and pain. Unfortunately, the patients would slowly develop a resistance to the antibiotic and the treatment would render useless.
IBS-C, IBS-D, and IBS-M each make up about 1/3 of the total market. Currently only 2/3 of that market has existing therapeutics while individuals who suffer from IBS-M don’t receive any medications.
What the current data shows is that in 2019 about 3.1 million cases where treated but about 10-15% of US citizens suffer from this condition. The market of IBS-M is untapped. A large portion of patients are refusing to use existing medications because of AEs. The estimated US market value for IBS-M is $2.4B in 202.
The therapeutics 4D has manufactured for IBS is a new player in the sector of LBPs (Live Biotherapeutic Products). They are the first therapy to show signals of efficacy in both IBS-C and IBS-D and Blautix has the potential to be the first ever therapy of IBS-M patients.
Two quotes from doctors working with patients who have IBS
Currently $LBPS is trading at a huge discount with the potential to give large returns. It is widely known that the biotech sector of the market can produce absurd returns. This is because of patents and the development of a new treatment making it a high priority and highly valued. What is special about this company is that it has unlocked a new door with their LBPS.
Their new partnership with Merck will aid in their growth and success. 4D will be successful in IBS, their test results have proved that. But what else will it work for? Asthma? Alzheimer’s? Multiple forms of Cancer? The more health conditions 4D can provide successful treatments for the more valuable their company will be. 4D’s market cap is around $150M. The product of IBS is knocking on the door of easily a $1B market sector. It is not unheard of for a biotech to increase at this absurd rate with a potential 5x return.
For our take on what makes a biotech company worth investing into, check our post here!