Biotechnology company 180 Life Sciences has identified a CBD analogue that will move forward in clinical development for inflammation and pain.
Born out of a merger of three companies, 180 Life Sciences is focused on the development of novel drugs that fulfil unmet needs in inflammatory diseases, fibrosis and pain.
A continuing collaboration since 1998 between the “father of cannabis” Professor Raphi Mechoulam, Hebrew University, Jerusalem, co-founder Sir Marc Feldmann’s Laboratory in Oxford, and 180 Life Sciences’ scientists, has led to the identification of a CBD analogue – HUM-217 – which was selected based on a screen of derivatives of CBD and CBG made by Mechoulam and which will be will be advanced to clinical development for chronic pain and early arthritis.
According to the company, the analogue has a novel composition of matter which would enable patent protection, robust preclinical efficacy in several established mouse models for treating pain and inflammation in vivo, and ease of scalability for GMP manufacturing.
Industry veteran and 180 Life Sciences CEO, Dr Jim Woody, commented: “180 Life Sciences is the merger of three companies – one in Israel with Dr Mechoulam, who was working on cannabinoids, one in Oxford, UK, that was working on anti-inflammatory agents, primarily anti-TNF, and one here in the US that works on a nicotinic acid receptor agonist.
“A long time ago, Dr Feldmann and I were working together and we were the first ones to ever invent an antibody against TNF. We showed it worked in rheumatoid arthritis and Crohn’s disease, psoriasis and ulcerative colitis, and it is now one of the standards of care called Remicade. There are probably 40 million people treated with anti-TNF so there are now no patients with rheumatoid arthritis in wheelchairs because of that drug and the follow on drugs.
“However, there are problems with anti-TNF’s because the drug is saving the joints but the pain doesn’t totally go away. So, what we are focusing on is making synthetic cannabinoids that will have the ability to be anti-inflammatory and anti-pain.
“We have now been able to do that – we selected our lead compound to move ahead and go through IND-Enabling studies. We have already tested our compound in inflammation models – there are animal models of inflammation that can give a good readout on whether this works or not – and we know that the compound is effective in those models. With the way it is constructed, it won’t be psychogenic and it is easily absorbed, so we can actually take enough of it or make it into a pill so, people could use it as opposed to regular cannabis that is made up of maybe 100 or more compounds.
“We will treat patients who have arthritis and receive anti-TNF, but it doesn’t quite make their pain go away, as you do not want your patients to have to use opioids, which is not very satisfactory. Steroids are another problem because of their side effects – a lot of them cause kidney problems, for example. This pill will be non-addictive, and also quite favourable for the pain.
“It turns out that there are two TNF-receptors, and one of them is inflammatory and the other one is anti-inflammatory so, down the road, we are going to make specific drugs against each of those to try to get away from the infectious disease complications. So, it is a whole new novel area but Dr Feldmann and I and others are very familiar with the TNF field.”
Dr Woody says that the anlaogue would be added to the regimen of doctors prescribing anti-TNFs as a large clinical trial, possibly all over Europe. Additionally, he says 180 Life Sciences are licensing more compounds from Oxford that have unique abilities to help tissue regrow after is damaged.
“In the cannabinoid area, I think this class of drugs probably has a lot of uses. Certainly, it’s being used in paediatric seizures and things like post-traumatic stress disorder, but these are not clean compounds, they are very complicated.
“So, I think for the field to move ahead, we need to do what we are doing – making very specific medicines and molecules, so we know what they are, we know how they work, and then we can address many of these other problems because there is a whole range of therapeutics there that will be quite helpful that I think will be tailored for different diseases.”
The company recently raised $15m through private placement, which will fund general corporate purposes, working capital, and the research and development of its programmes which are not funded by grants.
“We raised the funds to accelerate these programmes moving forward. It will almost all go into the projects themselves. We don’t have an office because we’re scattered between Israel and Oxford and Palo Alto and so, we plan to put almost all the money into the programmes and get them to move more quickly.”
Irish rugby athletes invest in CBD skincare and drinks
Irish rugby player Rob Kearney has signed a two-year partnership deal with a CBD brand.
Irish rugby player Rob Kearney has signed a two-year partnership and investment deal with a CBD brand, where he will also act as an ambassador.
Kearney is one of Ireland’s most accomplished rugby players, with a career that includes two tours with the British Lions and four Six Nations titles. He has also become a successful entrepreneur investing in different industries including the CBD market.
Poko is an Irish unisex skincare brand that offers a range of vegan products including muscle recovery balms, moisturisers and eye creams. It was created by Justine O’ Hanlon to help with problematic skin caused by polycystic ovary syndrome.
The collaboration with Kearney is one of the first partnerships that the brand have planned as they look to move into the European and UK market. Kearney is said to be a fan of the product line and plans to promote the partnership across TV, radio, print and social media.
He is hoping the brand will appeal to the growing male beauty market.
This partnership is the first of many high-profile brand collaborations with influencers across the U.K. and Europe the brand has planned. He believes that CBD is a powerful and versatile substance that should appeal to everyone looking for strength in their skincare.
He said: “I chose to work with Poko as they share many of the same values I do. Their passion and drive to bring skincare solutions to everyone is something I really felt I could stand behind. The stigma around male skincare is an area I really feel needs to be highlighted and education needs to improve. We all need to look after our skin and that starts with accessibility to products that are suitable for everyone.”
Poko co-founder Justine O’Hanlon said: “I’m very inspired by Rob’s career and to see the enthusiasm he has shown for our brand. We’ve always had a focus on providing skincare for everyone, and creating a brand like Poko allows us to reach male and female audiences. Having Rob onside to promote skin health is so important for us and we can’t wait to see what the next two years will hold for us.”
Kearney isn’t the only athlete investing in skincare. At the start of 2021, footballer David Beckham invested in the CBD and CBG brand, Cellular Goods who have launched its first products ahead of Christmas. The products are thought to be the first CBG skincare range in the UK.
Irish rugby and CBD
Earlier this year, former rugby player, Alan Quinlan, mixed martial arts athlete Cian Crowley, Cork GAA players, Diarmuid O’ Sullivan and Brian Hurley invested in Mynd. Mynd is a plant-based, CBD drink that has just entered Irish supermarkets. The athletes invested a combined EU2 million.
The fruit drinks are formulated to be low sugar with 25 mg of CBD.
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What can CBD do for rugby players?
It’s not just rugby players that could benefit from CBD, but any athlete that suffers from inflammation.
Acute inflammation is the immediate response to something it perceives as a threat such as a virus, increased workout strain or an irritant. Although inflammation can be part of the healing process, it can be very painful especially for athletes who have a strict training schedule. Chronic inflammation builds up over time and can lead to conditions such as arthritis.
A pre-clinical study on inflammation related to arthritis revealed that the levels were reduced when treated with a localised CBD treatment. The researchers stated that ‘CBD may be a safe, useful therapeutic for treating OA joint neuropathic pain.’
Concerns over ‘ethically unacceptable’ CBD testing proposed by FSA
A new report has highlighted that the UK industry is struggling under ‘scientifically unjustified, and ethically unacceptable’ toxicity testing for CBD products.
The report by DevelRx LTD and The Canna Consultants has raised concerns about the testing that businesses must take part in under the FSA guidelines.
DevelRx and The Canna Consultants have stated in the report that they believe the testing is ‘unethically acceptable’ and ‘scientifically unjust’ while drawing attention to the replicated animal testing for CBD products.
The Food Standards Agency (FSA) determined that all CBD products were to be classed as Novel Food in the UK and EU. They developed testing guidelines with guidance provided by the Committee on Toxicology (COT) in 2020 and declared that all businesses must submit scientific proof that their products were safe if they were to remain on sale. COT developed the guidance for their guidelines using data from GW Pharmaceuticals.
The report also draws attention to the ‘cherry picking’ of data given that the guidance is based on just one of 15 trials by GW Pharma for Epidiolex. The report stated that this is ‘superficial, scientifically flawed and has placed reliance in part on a biased data source that was part of a pharmaceutical company’s lobbying campaign to the US government to restrict the non-medical use of CBD by the US public.’
The authors developed a list of issues that they found within the data and testing which has formed the basis of the report.
Speaking with Cannabis Wealth, Steve Oliver, one of the co-founders of Canna Consultants raised his concerns about the testing CBD companies are forced to undertake.
“When the COT made their assessment, it was based on a document that GW Pharma supplied. That document is clearly a lobbying document. They highlighted adverse effects which didn’t stand up scientifically and contradicted their own efficacy and evidence of the safety of CBD at the levels we mention. So we have concerns and we have been raising this with regulators for 18 months and it’s been falling on deaf ears.”
He explained: “We got to access all of the clinical data then we asked them to conduct their own assessment and have it peer-reviewed. We found ten points where we demonstrate there are several statements in the COT document that contradicted the data they presented.
“They essentially cherry-picked some adverse events which were not representative of the much larger study they conducted. Those adverse events can be attributed to the other drugs that people were taking. We are very concerned that COT swallowed this and didn’t have the scientific experience, or was not prepared to drill down and test that. So they accepted the commercial organisation’s data.”
Some of the data from the Phase I GW trial raised concerns about the effect of CBD on the liver and potential reactions with other drugs. This led to the FSA suggestion that consumers keep within the recommended 70 mg per day despite the data showing no cause for concern on doses much higher than this.
The result of the new guidelines and increased testing has caused chaos for brands, in particular small to medium companies who may struggle to afford to test. This has led to every manufacturing company planning on making an application for their products having to conduct an extended 96-day, repeat dosing, rat toxicity study for each individual item. The effect for some brands has been devastating. Not only that, it has raised serious issues for brands that label their products as vegan or cruelty-free.
Animals are often forced to take CBD in these trials which are required for each ingredient. In May 2021, it had been reported that there were already over 800 applications to meet the deadline of 31 March. A high percentage of brands were forced to withdraw their applications due to costs or were rejected due to not being able to meet the high standards set.
Steve highlighted that there are a huge amount of companies who have tried but are unable to afford the fees causing them to ‘go to the wall’ as a result. He stressed that small companies are trying to do everything they can while the pharmaceutical companies already have their applications validated.
Steve said: “It forced people to go down the consortium route because some people who are selling wellness products brand them as vegan and cruelty-free. They are being corralled into sponsoring or contributing to animal testing which they don’t want to do. They have been told that if they don’t do that then they won’t have a business. Ethically, that is outrageous and morally it’s wrong.”
He added: “We are not against animal testing as required and needed for certain drugs but there is a requirement for that. Why would you go and retest on rodents when you already have the data for humans?”
The testing on animals raises serious ethical concerns for an industry that often carries products with cruelty-free or vegan labels. While some companies do publically make the choice, the report draws attention to the fact that many consumers may not know what is involved with this testing.
“It is important that people understand what is being tested. They are not sitting there cuddling these animals. They are being killed at the end of the trial and a necropsy takes place. Animals don’t naturally like to eat CBD oil or isolate so they are force-fed. It’s fundamentally wrong and we think it’s probably unlawful if it was put to the test.”
The effect for the industry if it were to gain a reputation for animal testing could be devastating. It raises further questions about how much retailers who supply a variety of brands know about what exactly is involved in the testing.
Steve said: “I’m not sure that some of these retailers know. If you have high-end retailers such as supermarkets or chemists selling a product that they thought was tested on animals then it would be removed. It’s very strange and damaging for our industry. So many people have gone down this route without challenging it.”
As the industry has moved to accept the regulations, guidelines and increased testing, is it now so far gone that it cannot change? If the guidelines were to change, how does this affect the companies that have already paid for extensive reports? The expense of testing for companies could mean companies would take issue with changes.
“We’ve got to realise that a lot of this testing isn’t taking place in the UK under good laboratory practices. The vast majority is taking place in America where you can go to places and as long as you have a chequebook, they will test it on whatever species you want. We hope someone will take notice because it’s wrong but the problem is, they have encouraged people to do this testing and now they have submitted it.”
He concluded: “They are tied up in knots now because if you are a company that spent a million pounds doing all of this testing, submitted your dossier then probably, quite rightly, you are going to have an issue with the regulator if they were to have a policy change. That can’t stop you trying to do the right thing and this is not the right thing on so many levels.”
Cannabis Wealth has reached out to the FSA and COT for comment.
Lamborghini Lifestyle Company moves into CBD industry with new beverage
The product line will contain CBD and CBG.
The Flora Growth Corp has signed a licensing agreement with Tonino Lamborghini to produce and distribute CBD beverages in North America and Columbia.
Tonino Lamborghini and Flora Growth Corporation stated that the product line will contain CBD and also cannabigerol (CBG) as part of the licensing deal. There has been an increase in interest surrounding CBG in products from oils to skincare as it is thought to offer many benefits alongside CBD including regulating appetite and sleep.
The products will be produced in Florida initially with a focus on e-commerce and retail channels and will launch in the first quarter of 2022.
The Lamborghini brand is best known for luxury cars and Formula One but they also offer menswear, sunglasses and suitcases as part of their lifestyle brand. The brand is also involved in real estate projects.
Luis Merchan, CEO of Flora said: “We are excited to partner with such a well-known luxury brand as Tonino Lamborghini, which already boasts a very successful line of beverages and aligns with Flora’s brand portfolio of high-end products.”
“This partnership is yet another step in the execution of Flora’s strategic plan to build a world-class house of brands and is also a major component of our sales and distribution strategy in the lucrative US market,” he added.
The CBD industry is thought to develop into a US$20bn dollar market by 2024 with a large percentage of growth from the edible and beverage sectors.
The company will be using Applied DNA Sciences. Inc molecular tagging and authentication technology to ensure product verification. The new technology will allow Flora to reduce the concerns of any illicit market or counterfeit products.
Molecular tagging, which is similar to small DNA particulars acts as a type of molecular barcode. It can be used to advance tracking and tracing in the cannabis industry. The molecular tags can be added to plants, oils, lotions, edibles, and packaging. It is invisible to the eye and safe to ingest according to the Food and Drug Administration (FDA).
Ferruccio Lamborghini, CEO and VP of the Italian company said: “Together with Flora, we aim at creating new and innovative products and experiences for the modern consumer’s wellbeing. Our branded beverages are studied to help people to achieve a sense of calm and coolness in both stressful times and ordinary daily routine.
“I am especially enthusiastic about the molecular tagging and authentication technology Flora will use to track with full transparency the top-notch ingredients origin.”