Ritter bombs final PhIII for sole lactose intolerance drug — shares plummet
More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.
This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).
The measures were taken on day 61, well into the real world evidence phase of the study (in which patients consumed their normal diets plus diary products) following a 30-day treatment period.
None of the secondary endpoints were met. Only 36.2% of the RP-G28 arm counted as responders with a meaningful benefit compared to 34.1%, but the one-sided p-value was an abysmal 0.284. The other differences also missed statistical significance.
All of Ritter’s eggs were in this one basket. Its already hammered stock $RTTR took a further 69% plunge to $0.32.
Founder and CEO Andrew Ritter, who has suffered from serious lactose intolerance since childhood, was betting that his company could bring the first treatment to the market. RP-G28 is a formulation of galacto-oligosaccharide, which is designed to stimulate growth lactose metabolizing bacteria in the gut, thereby alleviating symptoms.
The drug failed to elicit a statistically significant response rate compared to placebo in its previous trial, but the company insisted that the primary endpoint was actually met — once they eliminated a site with “significant irregularities” and changed the primary endpoint.
That study, published in 2017, had 368 patients. The current Phase III enrolled 557 in total.
“We are deeply disappointed in the results of the phase 3 clinical trial,” Ritter said in a statement. “We believe the clinical trial was well-designed and executed. We are continuing to analyze the results of the trial to better understand the data and clinical outcomes to assess a path forward, which may include alternative strategic options for the Company.”
Any plans will have to come quick. As of June 30, Ritter had $4.4 million in cash and cash equivalents, with a working capital of only $2 million.