Ritter Pharma CEO Andrew Ritter has been symptom-free since he became the test subject of the first iteration of his company’s lactose intolerance drug 20 years ago. Now, he’s determined to make the final product the first treatment approved by the US Food and Drug Administration (FDA) for a condition that affects 40 million people in the US alone.

It all started when severely lactose intolerant Ritter was a young child and was told by doctors that there was nothing he could do but avoid dairy products or suffer the consequences. After years of suffering, he decided it was time to find another way.

Ritter contacted leading experts in the field and, using himself as the first test subject, together they formulated and developed the first prototype product that gave him the ability to tolerate dairy products again.

But curing himself wasn’t the endgame. Unwavering in his mission to improve the lives of the millions of people around the world who also suffer from lactose intolerance, Ritter Pharma was formed, and the development of what is now the company’s leading compound – RP-G28 – started in earnest.

How the drug works

Currently between the Phase 2b/3 and Phase 3 stages of development, RP-G28 is a non-digestible oligosaccharide – a sugar, essentially – that modulates the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal (GI) tract to better metabolise lactose, thus improving lactose tolerance.

The idea is that people who suffer from lactose intolerance can take it as a powder with water twice a day for 30 days – after that, they can tolerate dairy products in the long term.

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“It works through the concept of colonic adaptation,” Ritter explains. “If you shift these lactose digesting bacteria, they will continue to thrive in your colon as you consume dairy products.

“There is a subset of patients that may need a retreatment periodically – for example, if you take antibiotics or have food poisoning – because your gut microbiome is a living organism, it ebbs and flows. But with all things equal, our product allows for improved lactose digestion and reduced symptoms of lactose intolerance.”

The clinical development process

Following successful Phase 2 trials with 62 patients, during which Ritter Pharma proved the drug’s mechanism of action (i.e. they saw increased lactose-metabolising bacteria in patients’ colonic flora) came the company’s biggest milestone to date: the completion of a Phase 2b/3 trial earlier this year.

Designed to test the safety and efficacy of RP-G28, the 377-subject study assessed patients with lactose intolerance symptoms measured on a Likert scale after a lactose challenge. Symptoms of abdominal pain, cramping, bloating and gas movement were then combined into a composite endpoint, agreed to by the US FDA and representing the key symptoms of lactose intolerance.

The trial design included a screening phase, a 30-day course of treatment phase, and a 30-day post-treatment ‘real-world’ observation phase, during which subjects were followed while lactose-containing food products were re-introduced into their diets.

Ritter Pharma was able to demonstrate that taking RP-G28 resulted in significant positive reductions in key symptoms of lactose intolerance across a variety of global and real-world outcome measures, suggesting a clinically meaningful benefit to subjects.

For example, 83% of subjects on the treatment reported adequate relief from lactose intolerance symptoms and 82% reported no or mild symptom severity. Moreover, the study’s real-world milk intake assessment showed that 59% of patients upped their milk intake from 0.2 cups per day to 1.5 cups per day, 39% more than placebo patients reported consuming. There were also no serious adverse events related to treatment.

Next steps

According to Ritter, the Phase 2b/3 study and the company’s subsequent meeting with the FDA have been incredibly helpful in Ritter Pharma’s clinical development efforts.

“We’ve provided the FDA with our Phase 3 plans and had a very productive dialogue with them, during which we received guidance, direction and expectations about our Phase 3 programme,” he explains, adding that Ritter Pharma plans to initiate Phase 3 clinical studies in the first half of 2018 and that, in preparation, manufacturing efforts have already commenced.

“If we get positive results, we expect, based on the clinical programme taking 1-1.5 years, that we can submit an NDA application to the FDA towards the end of 2019,” Ritter says, adding that there is also considerable opportunity to explore RP-G28’s mechanism of action – colonic adaptation – for other GI diseases, as well as immuno-oncology, metabolic and liver disease in the future.

In the meantime, Ritter himself is the ultimate advert for the treatment in its most basic form. He concludes: “I have been symptom-free for over 20 years. This is a very important unmet medical need – with over 40 million people suffering from lactose intolerance in the US and millions more worldwide. At the moment they don’t have any options available but to avoid dairy products or suffer the consequences. Our mission is developing the first FDA-approved treatment for them.”