Ritter Pharmaceuticals, a developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases announced additional findings and data analysis from its Phase 2b/3 study designed to evaluate lead candidate RP-G28 in subjects with lactose intolerance.
These additional results from the trial analysis demonstrate that:
- A clear drug effect was seen with significant positive reductions in key symptoms of lactose intolerance (LI) and across a variety of global and real world outcome measures.
- The treatment effect suggests a clinically meaningful benefit to subjects in significantly reducing symptoms of lactose intolerance.
- The study demonstrated safety with no serious adverse events related to treatment.
According to Andrew J. Ritter, President and co-founder of Ritter Pharmaceuticals, “As we continue to evaluate the results of this trial, we are increasingly excited by the strength of the data supporting RP-G28’s potentially significant and durable real-world treatment effect for patients suffering from lactose intolerance.”
About the Trial and RP-G28
The Phase 2b/3, multi-center, randomized, doubled-blind, placebo-controlled, parallel-group trial in 377-subjects was designed to determine the efficacy, safety, and tolerability of two dosing regimens of RP‑G28 in subjects with lactose intolerance. RP-G28 is a novel, non-digestible oligosaccharide of ultra-high purity developed to modulate the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal (GI) tract to metabolize lactose to improve lactose tolerance.
The trial 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 representing the key symptoms of lactose intolerance. This composite primary endpoint was agreed-to by the U.S. Food and Drug Administration (FDA) prior to unblinding the study results. The Phase 2b/3 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.
Collectively, the majority of analyses showed positive outcome measures and a clear drug effect and clinically meaningful benefit to subjects in the reduction of lactose intolerance symptoms across a variety of global and real-world outcome measures, including:
Key lactose intolerance symptoms assessments
Significant and meaningful symptom improvement was consistently seen across key individual LI symptoms (proportion of subjects on treatment that reported improvement in severity of each symptom):
- 56% reported significant improvement in abdominal pain (p=0.1046)
- 55% reported significant improvement in cramping (p=0.0257)
- 55% reported significant improvement in bloating (p=0.0282)
- 44% reported significant improvement in gas movement (p=0.0599)
In a more stringent assessment, many patients reported that they experienced complete elimination of lactose intolerance symptoms scoring a 0 out of 10 on a Likert scale post-treatment (proportion of subjects on treatment that reported complete elimination of each symptom):
- 31% reported complete elimination of abdominal pain (p=0.0144)
- 35% reported complete elimination of cramping (p=0.0020)
- 30% reported complete elimination of bloating (p=0.015)
- 16% reported complete elimination of gas movement (p=0.0005)
Global patient-reported assessments
The patient’s perspective on multiple aspects of their symptom severity and treatment benefit experience 30-days after treatment and adding dairy and milk products back into their diets:
- 83% of subjects on treatment reported adequate relief from lactose intolerance symptoms (p=0.042).
- 82% of subjects on treatment reported no or mild symptom severity (p=0.0013).
- 66% of subjects on treatment reported being very or extremely satisfied with RP-G28 preventing or treating their lactose intolerance symptoms (p=0.0302).
- 40% of subjects on treatment reported much or very much improvement from lactose intolerance symptoms when dairy was incorporated back into their diets (p=0.0343).
Real-world milk intake assessment
- At baseline, patients reported consuming 0.2 cups/day of milk. After taking RP-G28, treatment patients increased their milk consumption to 1.5 cups/day (p=0.0084), 39% more milk consumed per day than placebo patients reported consuming. This is important because the USDA recommends that healthy individuals should consume 1.5 cups/day.
- Overall, 59% of treatment patients consumed >1 cups/day of milk after being treated (p=0.0095).
- The increase in milk consumption is meaningful for dairy avoiders because it reflects increased lactose tolerance and may lead to more dietary calcium intake post-treatment as milk contains a high percentage of one’s daily intake of calcium.
- Safety was widely demonstrated with no serious adverse events related to treatment and the number of adverse events reported was similar between treatment and placebo groups.
The Company has been granted an End of Phase 2 meeting with the FDA, which will take place by the end of 2017. The End of Phase 2 meeting will be an important opportunity to consult with the FDA on finalizing the Phase 3 clinical program and identifying the remaining NDA-enabling package necessary for obtaining commercial approval of RP-G28 for the treatment of lactose intolerance. In preparation for the Phase 3 program, the Company has also commenced manufacturing efforts and plans to commence the Phase 3 clinical program in the first half of 2018.
“The further on-going analysis of our study data we are releasing today is proving to be important for demonstrating in the real-world that treatment with RP-G28 can safely yield both a clear drug effect and a clinically meaningful benefit for patients by using a study design and outcome measurements recommended by the FDA and as reported by patients,” according to Michael Step, CEO of Ritter Pharmaceuticals. “We are looking forward to completing our Phase 3 program with the ultimate objective of providing a durable treatment to people who suffer from lactose intolerance.”
Filed Under: Drug Discovery