Speaking with NutraIngredients, newly appointed CEO at LNC Therapeutics Dr Georges Rawadi said the company will shortly begin the task of out-licencing its nutritional solutions as it shifts focus onto drug discovery and microbiome therapies.
Rawadi said LNC has been actively developing its microbiome-based weight management product Stablor in the nutritional space for some time, but said new opportunities brought about by developing science in the microbiome space mean the company will shift away from nutrition and towards more pharma-focused biotech.
“Today there is a link between the microbiome and many significant diseases such as obesity, but also autoimmune diseases, inflammatory diseases, and certain cancers,” said the CEO. “All of those give you a wide range of indications and pathologies that potentially we could address by modulating the microbiome.”
As such, the new CEO says LNC is looking to transform its business model from a ‘nutrition based company’ into a biotech company focusing on drug discovery, and will look to partner with major pharmaceutical companies on this in the future.
However, it must first find licencing partners for its nutritional product Stablor – for which the company is in the process of recruiting for its second clinical trial.
“We've already completed one clinical trial that enrolled about 50 obese patients that had metabolic syndrome,” said Rawadi. “In that we showed that our product, Stablor, reduces visceral mass in these groups without affecting the lean mass. Now the company is running a second clinical trial which will be bigger than the previous one.”
“Our plan is to complete the ongoing clinical trials with Stablor as a nutrition compliment, but our business strategy for Stablor is to then licence out to another commercial partner on a global basis - for the commercialisation and distribution of the product,” he said.
Last year, EFSA rejected a health claim application by LNC relating to fat reduction from its Stablor product. At the time, the EFSA panel said there was insufficient evidence to demonstrate that Stablor contributed to decreases visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors.
The road ahead
Rawadi – who is a microbiologist by training – joined LNC Therapeutics as CEO in April 2018 after previously working in healthcare management and business development for major pharmaceutical players including Aventis (Sanofi), Galapagos, Cellectis and Celyad.
He told NutraIngredients that the company’s new business model will leverage its expertise in the microbiome field to develop new therapeutics and drive partnerships based on drug-discovery.
This new model will mean LNC focuses its resources on developing therapeutic targets and creating value by brining those therapeutics from pre-clinical stages into the clinical stages, said Rawadi.
“We are using this knowledge of the microbiome modulation to develop therapeutic products that are not nutritional, but are real therapeutic products based on our initial discoveries about microbiome modulation,” he said. “These are still in pre-clinical stage. We are looking at several angles either using the bacteria itself to create particular product, or using a derivative of these bacteria, or using compounds that modulate the bacteria.”
According to the CEO, the first pre-clinical targets in the microbiome therapy area relate to the Christensenella – a bacterial strain which is significantly associated with fat reduction, lean mass, and lowering of obesity.
“We are looking to understand how we can use Christensenella - or the mechanism of action of Christensenella - to produce a therapeutic product that will have applications in controlling obesity, metabolic disorders and associated pathologies that develop in an obese person,” he confirmed.
“Christensenella is our first bacterial lead, but we are looking to other opportunities,” he added. “Today it is still too early to talk about those, but I think the ambition of LNC is to develop a pipeline of multiple drug candidates based on the microbiome.”
Engaging pharma: Fundraising and partnering prospects
Since LNC will focus solely on the discovery of therapeutic targets, it will look to partner for commercialisation, said Rawadi.
“We will be focusing really on the discovery and development of breakthrough therapies based on the microbiome, and licencing that out to potential pharma partners.”
He said the French firm is now in the process of generating ‘solid proof of concept’ in pre-clinical models, which will ensure that the therapeutics can be manufactured at the right scale and with the right quality to allow a clinical trial.
“The company strategy there is to raise enough funds to bring those novel drug candidates to the clinical stage, and then when we are at the clinical stage then this would be the right time to start discussing partnerships,” he added – noting that early targets for partnering will include major pharmaceutical companies like Pfizer, Sanofi, Novartis, Johnson & Johnson, “and many others of the same size.”
Rawadi said LNC will be looking to go ahead with a second fundraising round to help fund the initial pre-clinical work that will then allow partnering.
The company completed a series A fundraising in September 2017, in which it raised €6.5 million and raised prospects of a potential IPO within the next few years, as reported by NutraIngredients at the time.
Now, with a new CEO at the helm, the company says that a series B fundraising – and a focus on developing a strong pipeline – will likely come before any IPO.
“Somewhere between the end of 2018 and early 2019 we will have to go for another fundraising tour to raise money that will allow us to operate for 2020 to 2021,” said Rawadi.
“We are looking to build a strong pipeline based on microbiome potential and to achieve that objective we will need additional funds,” he added. “Although IPO remains an important milestone for LNC Therapeutics, the company may go for a series B fundraising round as an intermediate step.”
Any series B fundraiser would likely be for a significantly higher investment value than the first round, the CEO added – noting that LNC will also be ‘ready to engage in discussions’ with pharma players on licencing in the next two to three years.
“That doesn't mean we will not be going out and making ourselves available for discussion and communicating to the external word about what we are doing [before that], to create awareness - so that when we are ready we can convert that,” he said.
While partnering in the microbiome therapeutics space may be two to three years away, LNC said it is already looking to partner on its nutritional product Stablor – which it suggests would not be sold as a general consumer product, but would be distributed through health practitioner channels.
At the moment LNC is running a second clinical trial on the Stablor product, and is looking to enrol a significant enough number of people into the trial before it looks to licence out.
"I think this would be the right time to start pitching to potential partners, but we are looking to partner this as soon as possible. Ideally before we complete the clinical trial, so that when it is completed and the data is positive, we have a partner that can start to prepare for the commercialisation,” said the CEO.
“We are talking today to many companies, but we are talking to mostly to very large companies that are active in the consumer health and nutrition side, and who can have a worldwide presence.”
“We are a looking for a company that can address the market in its globality. So this is the kind of profile we are looking to partner with,” he added.