A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of HEM1036 in Subjects With Low Anterior Resection Syndrome (LARS)

Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS

Start Date01 Jan 2024

Sponsor / Collaborator

HEM Pharma, Inc.

[+1]

NCT06101459 / Not yet recruitingNot ApplicableIIT

A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.
The main questions it aims to answer are:
Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?

Start Date01 Dec 2023

Sponsor / Collaborator

Asan Medical Center

[+1]

KCT0008816 / CompletedNot Applicable

Pilot Study to prove the reproducibility of the intestinal environment of PMAS(Pharmaceutical Meta-Analytical Screening) System through the production of Equol after intake of Soy Isoflavone

Start Date23 May 2023

Sponsor / Collaborator

HEM Pharma, Inc.

100 Clinical Results associated with HEM Pharma, Inc.

0 Patents (Medical) associated with HEM Pharma, Inc.

Literatures (Medical) associated with HEM Pharma, Inc.

22 Mar 2024·Cancer Research

Abstract 2804: Comparative analysis of microbial diversity and abundance in colorectal cancer patients before and after surgery

Author: Lee, Sunyoung ; Park, Ji Won ; Suh, Dong Ho ; Park, Hyeree ; Cho, Sung-Yup ; Jeong, Seung-Yong ; Jung, Eun Sung ; Park, Yu Jin ; Shin, Aesun ; Kim, Min Jung

AbstractBackground: Previous studies have indicated differing patterns of the microbiome in colorectal cancer (CRC) patients compared to healthy individuals. Yet, the changes in microbial features of CRC patients before and after surgery remain underexplored. This study aims to investigate the impact of surgical intervention on the gut microbial diversity and abundance at the patient level.Methods: This hospital-based study analyzed data from 36 CRC patients who underwent CRC surgery at the Department of Surgery, Seoul National University Hospital between January 2020 and May 2022. Fecal samples from these patients were collected twice, both before surgery and during the post-surgery follow-up period. DNA extraction from stool specimens was performed using the MAG-Bind Universal Pathogen kit. This was followed by amplification and sequencing of the 16S rRNA gene V3-V4 region, with subsequent bioinformatics analyses conducted using QIIME 2. To compare the alpha diversity indices of patients before and after surgery, we employed both the paired t-test and the Wilcoxon signed-rank test.Results: Out of the 36 patients, 21 were male and 15 were female, with a mean age of 63.8 years. The average duration between surgery and post-surgery fecal sample collection was 2.3 years. Post-surgery, the alpha diversity indices decreased compared to pre-surgery, but the differences were not significant, except for Faith's PD. At the phylum level, Firmicutes and Actinobacteriota, both recognized as beneficial bacteria, increased in abundance after surgery, while Bacteriodota, typically considered harmful, significantly decreased. At the genus level, variations in microbial abundance also showed an increase in Blautia, Bifidobacterium, and Collinsella, and a decrease in Enterococcus, Romboutsia, and Faecalibacterium. The rise in Bifidobacterium abundance following surgery suggests a gut environment altered by the surgery to favor beneficial bacteria. However, a specific species decline in Bifidobacterium adolescentis was observed, highlighting that CRC surgery may have distinct impacts on different bacterial species.Conclusions: Our study indicates a slight decline in gut microbiome diversity following surgery. At the phylum level, there was an observed increase in beneficial bacteria and a decrease in harmful bacteria post-surgery, suggesting potential health improvements in CRC patients. Further research, particularly with a larger sample size and encompassing a broader range of bacteria, is needed to better understand the patterns and implications of microbiome variation in relation to surgical outcomes. Such insights could be pivotal in optimizing patient care and recovery strategies post-surgery.Citation Format: Hyeree Park, Min Jung Kim, Ji Won Park, Seung-Yong Jeong, Aesun Shin, Sung-Yup Cho, Eun Sung Jung, Dong Ho Suh, Sunyoung Lee, Yu Jin Park. Comparative analysis of microbial diversity and abundance in colorectal cancer patients before and after surgery [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2804.

24 Jan 2024·Journal of Crohn's and Colitis

P140 Serum Metabolomic Biomarkers Can Identify and Characterize Associated Subtypes and Phenotypes in Inflammatory Bowel Disease

Author: Kang, H ; Suh, D H ; Jung, E S ; Lee, C K ; Kim, J ; Ji, Y ; Oh, S J ; Park, Y J

AbstractBackgroundMetabolomics is increasingly recognized for uncovering pathophysiology and identifying diagnostic and prognostic biomarkers in inflammatory bowel disease (IBD). This study focuses on exploring comprehensive serum metabolomic profiles and corresponding specific metabolic pathways, in order to differentiate IBD patients from healthy individuals and to accurately identify IBD subtypes (Crohn's disease [CD], ulcerative colitis [UC]) through serum biomarkers with high patient acceptability.MethodsSerum samples with matched clinical metadata were comprehensively collected from patients with IBD at Kyung Hee University Hospital, Seoul, Korea. Corresponding samples from normal controls (NCs) were obtained for comparison. Untargeted profiling was performed with Gas Chromatography-Time-Of-Flight-Mass Spectrometry, and targeted profiling of bile acids and tryptophan used Liquid Chromatography-Triple Quadrupole-Mass Spectrometry. The identification of distinct metabolites and potential biomarkers was achieved through extensive univariate and multivariate statistical analyses. Receiver operating characteristic (ROC) curves and metabolic pathway analyses were also conducted.ResultsA total of 346 subjects were analyzed, comprising 258 IBD patients (134 with CD and 124 with UC) and 88 NCs, Table 1. The patients with IBD were clearly clustered from the NCs, while IBD subgroups were not clearly separated from each other in the nontargeted profiling. Tryptophan and indole-3-acetic acid were elevated in both patients with CD and UC, while kynurenine and indole-3-propionic acid increased only in CD. Conversely, patients with UC had lower levels of indole-3-acetic acid, serotonin, and acetylcholine compared to CD. The ratio of primary and secondary bile acids was also significantly decreased in both patient groups compare with NCs. The ROC curves (Figure 1A) showed good discriminatory power for NCs vs CD (AUC:0.9738), NCs vs UC (AUC:0.9887), and UC vs CD (AUC:0.7140). Pathway analysis of the identified metabolites showed a sustained change in glyoxylate and dicarboxylate metabolism/alanine, aspartate and glutamate metabolism/glycine, serine and threonine metabolism associated with all comparisons (NCs vs UC, NCs vs CD, UC vs CD). Beta-alanine, arginine, and proline metabolism were linked to IBD compared to NCs. Glycerolipid metabolism distinctly differed between UC and CD (Figure 1B-1D). Network analysis revealed associations between metabolomic markers and specific clinical phenotypes of IBD subtypes.ConclusionThis study demonstrates that serum metabolomic biomarkers are novel and effective tools for diagnosing IBD, as well as for identifying and characterizing its subtypes and associated phenotypes.

01 Nov 2023·Biomedicine & Pharmacotherapy

The animal protein hydrolysate attenuates sarcopenia via the muscle-gut axis in aged mice

Article

Author: Park, Hae-Jin ; Kwon, Eun-Young ; Lee, Ji-Yoon ; Ji, Yosep ; Bae, Heekyong R ; Shin, Su-Kyung

Age-related muscle loss and dysfunction, sarcopenia, is a common condition that results in poor quality of life in the elderly. Protein supplementation is a potential strategy for preventing sarcopenia and increasing muscle synthesis, but the effectiveness of protein type and level in improving sarcopenia is not well understood. In this study, we compared animal protein hydrolysate (APH), which has a high protein digestibility-corrected amino acid score (PDCAAS) and low molecular weight, with casein as a control group to investigate the effects and mechanisms of sarcopenia improvement, with a particular focus on the gut-muscle axis. APH supplementation improved age-related declines in muscle mass, grip strength, hind leg thickness, muscle protein level, muscle fiber size, and myokine levels, compared to the control group. In particular, levels of plasma cortisol, muscle lipids, and muscle collagen were markedly reduced by APH supplements in the aged mice. Furthermore, APH efficiently recovered the concentration of total SCFAs including acetic, propionic, and isovaleric acids decreased in aged mice. Finally, APH induced changes in gut microbiota and increased production of SCFAs, which were positively correlated with muscle protein level and negatively correlated with pro-inflammatory cytokines. In conclusion, APH can help to inhibit age-related sarcopenia by increasing muscle synthesis, inhibiting muscle breakdown, and potentially modulating the gut-muscle axis.

100 Deals associated with HEM Pharma, Inc.

100 Translational Medicine associated with HEM Pharma, Inc.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

HEMP-001	Depressive Disorder, Major More	Phase 2
Lactobacillus Fermentum (HEM Pharma)	Low anterior resection syndrome More	Phase 2
HEMP-003	Pulmonary Disease, Chronic Obstructive More	Preclinical
Autism Spectrum Disorder (HEM Pharma)	Autism Spectrum Disorder More	Discovery
Constipation (in Children)(HEM Pharma)	Constipation More	Discovery

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