Celiac disease drug candidate Laazotide fails phase 3 trial

On June 21, North Carolina-based 9 Meters Biopharma , which works to develop new treatments for rare or debilitating digestive diseases, said it will discontinue a Phase 3 clinical trial of larazotide for celiac disease due to disappointing interim resul.

Celiac disease is an autoimmune disease that occurs in the gastrointestinal tra.

Larazotide is a synthetic eight amino acid peptide tight junction modulator that inhibits paracellular permeabili.

The CedLara trial is a Phase III clinical trial in patients with celiac disease who continue to experience gastrointestinal symptoms while adhering to a gluten-free di.

The results were surprising as larazotide had shown positive results in a previous phase II clinical tri.

Larazotide has also shown positive effects on other gastrointestinal disorde.

However, after a 12-week double-blind treatment period and an additional 12-week ongoing safety period, results did not show that larazotide was effecti.

To this end, 9 Meters engaged an independent statistician to analyze the interim results to reassess the treatment group size needed to detect a statistically significant clinical effe.

Despite disappointing results from the Phase III CedLara trial, 9 Meters said it will conduct an additional analysis of the Phase 3 data to determine whether a subset of patients may respond to treatme.

"We plan to continue analyzing the data in the coming weeks to determine whether other individuals or groups of celiac disease symptoms may benefit from treatment with larazoti.

The company also said the setback for larazotide would not affect its other drug candidat.

"Despite this result, 9 Meters continues its mission to develop new treatments for rare or debilitating gastrointestinal diseases, and we remain enthusiastic about the promise of vurolenatide for the treatment of short bowel syndrome and our early pipeli.

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On June 21, North Carolina-based 9 Meters Biopharma , which works to develop new treatments for rare or debilitating digestive diseases, said it will discontinue a Phase 3 clinical trial of larazotide for celiac disease due to disappointing interim resul.

Celiac disease is an autoimmune disease that occurs in the gastrointestinal tra.

Larazotide is a synthetic eight amino acid peptide tight junction modulator that inhibits paracellular permeabili.

The CedLara trial is a Phase III clinical trial in patients with celiac disease who continue to experience gastrointestinal symptoms while adhering to a gluten-free di.

The 24-week study included 525 patients, who were evenly distributed among the trial's three arms, one receiving larazotide at a dose of 25 mg, one receiving larazotide 5 mg, and one receiving a place.

The primary endpoint of the study was the mean change from baseline in celiac disease symptom severity based on the CeD PRO (Celiac Disease Patient-Reported Outcome) abdominal domain score over 12 wee.

The results were surprising as larazotide had shown positive results in a previous phase II clinical tri.

The previous study included 342 adult patients with celiac disease who had been on a gluten-free diet for at least 12 mont.

In these patients, 5 mg larazotide treatment significantly reduced celiac disease sympto.

Larazotide has also shown positive effects on other gastrointestinal disorde.

In February, 9 Meters Biopharma published data on the use of prazotide in children withmultisystem inflammatory syndrome caused by COVID-19
in the journal Critical Care Discover.

Gastrointestinal symptoms improved significantly in all four children treated with larazoti.

In addition, these children had a shorter mean hospital stay compared with children who did not receive larazoti.

However, after a 12-week double-blind treatment period and an additional 12-week ongoing safety period, results did not show that larazotide was effecti.

9 Meters Biopharma has an independent statistician analyzing the interim results to re-estimate the treatment group size required to detect a statistically significant clinical effe.

To this end, 9 Meters engaged an independent statistician to analyze the interim results to reassess the treatment group size needed to detect a statistically significant clinical effe.

The analysis showed that a larger number of patients is still required to determine a significant clinical outcome between placebo and larazoti.

Therefore, the company decided to abandon the tri.

Despite disappointing results from the Phase III CedLara trial, 9 Meters said it will conduct an additional analysis of the Phase 3 data to determine whether a subset of patients may respond to treatme.

"We plan to continue analyzing the data in the coming weeks to determine whether other individuals or groups of celiac disease symptoms may benefit from treatment with larazoti.

Completing the analysis and working with the FDA will determine further plans for larazotide for the treatment of celiac disease," said Patrick Griffin, MD, FACP, Chief Medical Officer at 9 Mete.

The company also said the setback for larazotide would not affect its other drug candidat.

Resources from the CedLara trial will be reallocated across the company to focus on other areas, particularly its drug vurolenati.

"Despite this result, 9 Meters continues its mission to develop new treatments for rare or debilitating gastrointestinal diseases, and we remain enthusiastic about the promise of vurolenatide for the treatment of short bowel syndrome and our early pipeli.

" Prior to final analysis, financial and human resources previously dedicated to this research will be redeployed to advance our vurolenatide development program and our early product candidates," 9 Meters CEO and President John Temperato said in a statement said.

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