RDHL

RHB-102 (Bekinda®)

Gastroenteritis & gastritis

Stage (next event)

Expected Date

Phase 3

TBD

Catalyst Info & Data Links

TITLE: RHB-102 (Bekinda®) in Gastroenteritis & gastritis

  • ClinicalTrial.gov (NCT02246439): BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (GUARD)


  • ClinicalTrial.gov (NCT02757105): Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)


WHAT IS THE CATALYST EVENT?

  • Phase 3


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD


PRIOR DATA

PRESS RELEASES

Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • RHB-102 (Bekinda) is a proprietary, bimodal extended-release (24 hours) oral tablet formulation of, ondansetron, covered by several issued and pending patents. A positive first Phase 3 clinical study with RHB-102 (Bekinda) for the treatment of acute gastroenteritis and gastritis successfully met its primary endpoint. A positive Phase 2 study with RHB-102 (Bekinda) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), presented at the Digestive Diseases Week (DDW) meeting in 2018, also successfully met its primary endpoint.

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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