Delving into the Latest Updates on PRIM-DJ2727 with Synapse

Overview

Basic Info

Drug Type

Fecal microbiota transplantation

Synonyms-

Target-

Action

modulators

Mechanism

Bacteria replacements, Microbiome modulators

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases

Active Indication

ConstipationScleroderma, Systemic

Inactive Indication

Clostridium difficile infectionColitis, UlcerativeHIV Infections+ [2]

Originator Organization

The University of Texas Health Science Center at Houston

Active Organization

The University of Texas Health Science Center at Houston

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.

Start Date03 Mar 2025

Sponsor / Collaborator

The University of Texas Health Science Center at Houston

NCT05786404

/ RecruitingPhase 1IIT

A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

Start Date15 Dec 2023

Sponsor / Collaborator

The University of Texas Health Science Center at Houston

NCT04371653

/ WithdrawnPhase 2IIT

A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)

Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .

Start Date01 Dec 2023

Sponsor / Collaborator

The University of Texas Health Science Center at Houston

100 Clinical Results associated with PRIM-DJ2727

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100 Translational Medicine associated with PRIM-DJ2727

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100 Patents (Medical) associated with PRIM-DJ2727

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100 Deals associated with PRIM-DJ2727

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Constipation	Phase 2	United States	The University of Texas Health Science Center at Houston	03 Mar 2025
Scleroderma, Systemic	Phase 2	United States	The University of Texas Health Science Center at Houston	03 Mar 2025
Metabolic dysfunction-associated steatotic liver disease	Phase 2	-	The University of Texas Health Science Center at Houston	01 Dec 2023
Colitis, Ulcerative	Phase 2	United States	The University of Texas Health Science Center at Houston	14 Sep 2020
Clostridium difficile infection	Phase 2	United States	The University of Texas Health Science Center at Houston	21 Dec 2017
Parkinson Disease	Phase 2	-	The University of Texas Health Science Center at Houston	15 Jul 2017
HIV Infections	Phase 1	United States	The University of Texas Health Science Center at Houston	12 Apr 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03298048 (CTgov)	Phase 2	Clostridium difficile infection	17	Low fecal microbiota dose (Low Fecal Microbiota Dose)	thwhxvsozi = ybsgamcowh cwxpcjywuf (tsceacwruo, hgadogunzc - pcgfdoasaz) View more	-	06 Mar 2020
				Mid fecal microbiota dose (Mid Fecal Microbiota Dose)	thwhxvsozi = cjovvhqzbn cwxpcjywuf (tsceacwruo, woddrhshuq - cplnkenvzw) View more