For over 100 chronic inflammatory and autoimmune diseases, steroids remain the first-line treatment – could STERO Biotechs bring the next CBD-based alternative?
Following one of the first multi-million exits by a cannabis-based drug research company, the founders of Talent Biotechs take on the steroid challenge at their new start-up: STERO Biotechs, does this mean a new CBD-based alternative is on the horizon?
Though effective in the majority of cases, millions of patients on high doses and/or prolonged use of steroids, find their lives disrupted by side effects. From minor discomfort to devastating and even life-threatening conditions.
Many patients are refractory, and do not respond to steroid treatment at all. Biotech treatment options offer better results for multiple conditions, but their high costs make them less attractive, and they still may have some negative side effects. Now, at last, STERO Biotech CBD offers a viable, safer, and more affordable alternative.
“It’s no coincidence that we at STERO Biotechs have discovered that besides other positive effects, administering CBD allows us to reduce patients’ steroid doses and in some cases, eliminate their use or increase their effectiveness,” says Dr. Sari Prutchi Sagiv, CSO of STERO Biotechs.
In the right place, at the right time
While its use in Israel is still limited to a small number of specific medical conditions, the country is a world leader in advanced research of Cannabis. As early as 1964, Cannabis research pioneers, Professor Raphael Mechoulam of the Hebrew University of Jerusalem’s Centre for Research on Pain and Professor Yechiel Gaoni of the Weizmann Institute, were the first to isolate a cannabinoid—Tetrahydrocannabinol (THC), the psychoactive chemical component in marijuana. Since then, progress has come in giant strides.
The Israel Ministry of Health is hard at work on formulating regulation in all relevant areas: exports have been approved and are soon to begin, Cannabis is being studied in almost every scientific, and academic institution through multiple approaches. Currently, there are at least 22 clinical trials in phases 0-2 (GlobalData), eight major growing companies and countless startups, investigating applications across industry sectors such as agriculture, medical devices, cosmetics, and pharmaceuticals.
Why STERO Biotechs?
“Within this thriving environment, our company can provide the answer to an unmet need in over 100 diseases by synergistically harnessing three key success factors – valuable granted IP, a strategic partnership with a major HMO, and world-class research talent with a proven track record,” Dr. Prutchi Sagiv explains.
STERO Biotechs Ltd., founded in 2017 and headquartered in Israel, is a clinical stage company committed to the research and development of novel and improved Cannabidiol (CBD)-based drugs for steroid–sparing therapy in a great number of medical indications that could potentially benefit millions of patients, focusing mainly on inflammatory and autoimmune diseases. The company aims to develop products that will not only reduce side effects but also the need for steroid therapy, whilst also increasing the effectiveness of steroid treatment in non-responsive (refractory) patients.
The founders of STERO Biotechs, David Bassa, Dr Moshe Yeshurun, and Dr Sari Prutchi Sagiv, are the former leaders of Talent Biotechs, one of the few companies in the world conducting FDA oriented Cannabis-based drug development clinical trials since 2011. STERO Biotechs’s knowledge and preliminary results are based on findings in their groundbreaking CBD-based study in GvHD (while still at Talent).
GVHD remains a major cause of morbidity and mortality after Bone Marrow Transplantation. Only 60% of patients respond to first-line therapy with high-dose steroids. The mortality rate among patients with steroid refractory severe acute GVHD (grades 3-4) is over 80%. In a Phase 2 study conducted by Talent Biotechs, ten patients with severe acute GVHD and refractory to standard treatments with high-dose steroids were administered daily doses of CBD for up to three months. Nine out of ten responded to treatment, most of them achieving complete response, and the rest near complete response.
This preliminary study showed CBD administration either enhanced the therapeutic effect of steroids or reduced steroid dosage while maintaining or improving the steroid’s therapeutic effect. In all patients treated, the steroid dose administered with CBD was gradually decreased over time. Even more surprisingly, patients refractory to steroid treatment also presented significant improvement under the CBD treatment.
In the dramatic case of an Acute Grade IV patient with a GvHD condition treated with the prolonged use of steroids whose side effects were affecting his liver, gastrointestinal function, and skin, all symptoms had disappeared following a two-month treatment with CBD. After reviewing these results, the FDA recommended applying for the Breakthrough Therapy and Fast Track Designations, to accelerate the approval process.
This unprecedented success led the same team to found STERO Biotechs, in order to begin research in a new, previously untapped direction. The company was granted an exceptional patent in the US (August 2018) and pending in other geographies, covering over 100 autoimmune and chronic inflammation diseases, using CBD from any source (botanic or synthetic), in any combination (with other ingredients added), in any dosage, and through any delivery system, which paves the way for what could be tremendous progress in future research, while enhancing the company’s ability to raise capital.
Why Inflammatory and Autoimmune Diseases?
Steroids, naturally produced by our bodies in small amounts to help control various functions, are also manufactured artificially as drugs targeting a range of chronic inflammatory autoimmune diseases and cancer. While Steroids can influence immune responses, they often produce side effects with varying degrees of gravity, depending on the dose, type, and length of treatment (long-term treatment is above THREE months).
Some of these are: increased risk of infections, diabetes mellitus, sleep disorders, mood swings, psychosis, acne, edema, neuropathy, hypertension, osteoporosis, aseptic necrosis of the bone, myopathy, adrenal cortex suppression, lymphocytopenia, cataract, narrow-angle glaucoma, and growth retardation.
About 23m people suffer from autoimmune diseases in the US alone, at total treatment costs of approximately €13.25 bn ($15 bn). The global potential is huge, especially if we add the savings from improvements in health, quality of life, and productivity of patients.
STERO Biotech’s CBD-based therapy has the potential to deliver
Equipped with this combination of IP, partners and an excellent team of scientists, STERO Biotech has begun Phase IIa clinical trials for various indications:
The first trial in autoimmune hepatitis started officially in February 2019. Autoimmune hepatitis is a disease in which the body’s own immune system attacks the liver and causes it to become inflamed, a serious condition that may worsen over time if left untreated, and lead to cirrhosis and liver failure.
The study titled ‘A Phase 2a open label, single arm study to evaluate the safety and efficacy of Cannabidiol (CBD) only as maintenance therapy and steroid sparing in patients with stable autoimmune hepatitis’, is being led by Dr Assaf Issachar, a senior physician in the Liver Institute at the Rabin Medical Centre, will include 15 patients and its duration will be about 12 months.
“AIH is a rare cause of long-term hepatitis in which the immune system attacks the liver. Eventually, the damage can be so serious that the liver begins to fail, and, in some cases, flare ups can even be fatal. It is crucial to prevent these flare ups, meaning many patients require on-going life-long treatment with steroids. I am very excited about this clinical trial, as CBD treatment could potentially prove to be a safe and effective steroid-sparing option for such patients,” says Dr Assaf Issachar.
Steroid-Dependent Crohn’s Disease
The second clinical trial, approved by the Helsinki committee in April 2019 and planned to start in the following months, will be on Steroid-dependent Crohn’s disease, an inflammatory bowel disease (IBD). The inflammation it causes in the digestive tract, can lead to excruciating abdominal pain, severe diarrhoea, fatigue, weight loss and malnutrition. Inflammation caused by Crohn’s disease can involve different areas of the digestive tract in different people.
The study is titled ‘A Phase 2a, randomized, double-blind, placebo-controlled, multicentre study to evaluate the safety, tolerability and efficacy of Cannabidiol (CBD) as a steroid-sparing therapy in steroid-dependent Crohn’s disease patients’, and will be conducted by Dr Timna Naftali, of the Institute of Gastroenterology and Hepatology at the Meir Hospital. It will include 28 patients and its duration is also estimated at 12 months.
There might be light at the end of the digestive tract. More clinical trials are in the pipeline with an additional one planned to commence in 2019. Stay tuned for more news.
Please note, this article will appear in issue 10 of Health Europa Quarterly, which will be available to read in July 2019.