The microbiome and migraines: ADM Biopolis and Protexin spotlight probiotic potential during CPhI Worldwide 2019

07 Nov 2019 --- ADM Probiotics, within ADM Health and Wellness, was showcasing the synergies between sister companies Protexin and Biopolis at the ongoing CPhI show in Frankfurt, Germany, this week. Taking precedence at the stand was the recent launch of Bio-Kult Migraé, a 14-strain live culture supplement that has been proven in clinical trials to lessen the severity and occurrence of severe migraines, launched by Protexin. Speaking to NutritionInsight on the show floor, experts at the stand also highlighted the regulatory boundaries in the probiotic arena, as well as spaces to watch for 2020.

“Biopolis has the facilities to help with the preclinical side of research. When you come up with the idea of a product for which there is a niche, you need to test that in a model, design a clinical trial and run the trial. This is where the companies work well together. Biopolis helps with the preclinical side of it and preconception with testing models. ADM Protexin has experience in the clinical side and in human studies. Once the product is successful, it can be launched on the market,” Dr. Malwina Naghibi, Senior Medical Scientific Liaison at Protexin, tells NutritionInsight.

Daniel R. Calvo (left) and Dr. Malwina Naghibi (right) at CPhI Worldwide.Protexin examined the “niche” link between microbiome bacteria and migraine symptoms in its launch of a supplement coined Migraé, which was released on the market earlier this year. Migraine headaches affect 14 percent of the UK population, meaning approximately six million people are impacted by the symptoms. On top of this, more than half of the patients are unhappy with their current treatment. In this way, the company saw a market opportunity for tackling the chronic issue with probiotics.

“In theory, people might not think that there is any connection between the microbiome and migraines, but there are several pathways potentially explaining that link. We don’t exactly know the mechanism behind it, but actually, if you speak to neurologists and experts in the migraine space, they will tell you that they don’t understand migraines themselves. If you do not understand the mechanism behind the disease, it comes as no surprise that you cannot pin down the exact pathway through which you could improve the disease,” she adds. 

Building on the knowledge the company holds in the gut-brain axis sphere, they will soon be launching a supplement targeting cognition, coined Mind. This will be a space to watch, Dr. Naghibi says.

Intersection between nutraceuticals and pharma
A resonating theme at CPhI Worldwide was the increasingly blurred lines between certain nutraceutical spaces, such as the shrinking divide between probiotics and pharma.

Speaking on this, Daniel R. Calvo, Marketing & Communications Manager ADM Biopolis, tells NutritionInsight how complex the space is due to the regulations. 

“In Europe alone, regulations are quite restrictive. For example, we are not allowed to use the term probiotic because, per se, it is considered a health claim. There are different communication tools that we use as a company to overcome these clear barriers. Of course, there are regulatory agents, such as the US Food and Drug Administration (FDA), which is more flexible. This includes a lot of challenges, especially on the B2C side when developing different products because those regulations will definitely affect your development strategy.”Published in January 2019, a randomized control trial saw improvement in frequency and severity of migraines after using the supplement.

This is particularly salient as consumers are becoming increasingly nutrition savvy. Knowledge is increasing, and so are demands for transparency and information. Misleading health claims in the past have created a far more conscious market. 

Speaking at the CPhI 2019 Annual Report press conference at the show on Tuesday, Stewart Needleman, Chief Commercial Officer of Piramal Pharma Solutions, echoed this. He reported that patients are seeking a greater deal of information, dubbing them the “globally informed patient.”

“There is little as an industry that we can do to change regulations, but we do what we can. ADM Protexin is based in the UK, and because we are a scientifically-driven company and we have a long history of working in that space, we have been able to reach to the government and work on new policies and help them understand the limitations,” adds Dr. Naghibi.

Importantly regulations need to be created by people who understand them. Otherwise, they will not work for either the policy side or the manufacturing side. “What we want to achieve is a safe space for consumers to receive good, safe and effective products, but also a space where the industry can grow and thrive,” she adds.

Looking to the future, the companies will continue to work together to target the industry’s biggest trends. But what are they? 

Calvo highlights skin health and the growing body of literature and scientific evidence on the relationship between the microbiome and skin diseases. He also notes that fertility is a space worth further exploration for probiotics, with Biopolis already offering some supplements for both male and female fertility. 

Dr. Naghibi speculates that the gut-brain axis will continue to attract research and propel NPD. “If you look into the literature where the microbiome plays a role, whether it’s depression, stress, Parkinson’s – you will find that there are hints about the microbiome and those conditions. We’re exploring their potential and the groups that would benefit from them the most because it is all about creating products for the patients.”

By Laxmi Haigh, with additional reporting by Anni Schleicher