Ritter's microbiome modulator fails lactose intolerance phase 3

FierceBiotech | September 13, 2019

A phase 3 trial of Ritter Pharmaceuticals’ lactose intolerance prospect RP-G28 has missed its primary endpoint. The oligosaccharide microbiome modulator was no better than placebo at reducing lactose intolerance symptoms, leaving Ritter considering whether to look for strategic alternatives. Ritter moved RP-G28 into the 557-subject phase 3 in the belief the drug could modulate bacteria in the large intestine to increase the metabolism of lactose. In doing so, Ritter anticipated reducing the severity of abdominal pain, cramping, bloating, gas and other symptoms associated with intolerance to the allergen. That theory is now on the ropes. After 60 days, the phase 3 tracked a 3.159 reduction over baseline in the lactose intolerance symptoms of people who took RP-G28. However, the mean reduction in the placebo group, 3.420, was numerically bigger still, causing the trial to miss its primary endpoint. Ritter saw a similar pattern across the secondary endpoints. A key secondary endpoint found 36.2% of people in the RP-G28 arm experienced a meaningful treatment benefit. The placebo was almost as efficacious, though, with 34.1% of people experiencing a meaningful benefit. Ritter said RP-G28 and placebo performed similarly across other secondary endpoints, too.

Spotlight

Even before the 1980s, the notion of attaching a cytotoxic agent to a tumor-specific antibody captured the collective imagination of the international drug development community. Were antibody-drug conjugates (ADCs) the magic bullets everyone was looking for that could, among other things, cure cancer? The evolution of ADCs is a stunning example of how global research can sculpt a new technology, gradually refining it in ways no one initially imagined, often spurred by other discoveries that surface along the way.

Spotlight

Even before the 1980s, the notion of attaching a cytotoxic agent to a tumor-specific antibody captured the collective imagination of the international drug development community. Were antibody-drug conjugates (ADCs) the magic bullets everyone was looking for that could, among other things, cure cancer? The evolution of ADCs is a stunning example of how global research can sculpt a new technology, gradually refining it in ways no one initially imagined, often spurred by other discoveries that surface along the way.

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CSL Plasma | August 08, 2022

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INDUSTRIAL IMPACT

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ProPhase Labs, Inc. | June 29, 2022

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