HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS CONFERENCE CALENDAR
LATEST UPDATES » Volume 20, Volume 2, February 2016 Biomedical Research Governance       » Tissue banking in Singapore — An Evolving Enterprise       » China Recognizes Prominent Scientists and Stresses on Innovation       » NUS Researchers Uncover Potent Parasite-killing Mechanism of Nobel Prize-Winning Anti-Malarial Drug       » A New Water Robot "Born" to Detect Water Quality       » Probing the Mystery of How Cancer Cells Die       » Researchers Find Link between Processed Foods and Autoimmune Diseases       » Unravelling the Genetics of Pregnancy and Heart Failure      
BIOBOARD - EYE ON CHINA
Hua Medicine's novel glucokinase activator reports positive Phase 1a data for diabetes and initiates Phase 1b trials
Hua Medicine, a leading innovative drug development company in China, has started a multicenter, multi-dose Phase 1b Trials for Diabetes. The company had previously obtained positive results from a Phase 1a trial evaluating HMS5552, a glucokinase activator (GKA) for Type 2 Diabetes, and demonstrated, even at single doses, significant effects in a variety of biochemical diabetes markers such as glucose and glucose-stimulated insulin release (GSIR).

In the Phase 1a study, groups of healthy volunteers were treated with HMS5552 in increasingly higher dose groups. In a dose-dependent manner, HMS5552 consistently increased post-meal GSIR multiple-fold above the post-meal insulin levels seen in the placebo group, with very low risk for hypoglycemia.

"Having abnormally high blood glucose levels after a meal is typical of diabetics and pre-diabetics with impaired glucose tolerance or IGT. Asian patients in particular are at even higher risk for diabetes and IGT compared to Western patients, because of both dietary and genetic factors. In particular, Chinese diabetics suffer from an earlier deterioration in beta cell function. That's why these Phase 1a results showing higher GSIR profiles were important in affirming that HMS5552 should be particularly beneficial in treating Chinese and Asian-dominant diabetics," said Yi Zhang, M.D., Director of Clinical Development at Hua Medicine.

The Phase 1a study of HMS5552 was a blinded, placebo-controlled, dose-escalation study in 60 healthy volunteers. The study was designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and MOA-validation of HMS5552. HMS5552 was evaluated in six single ascending doses ranging from 5mg, 10mg, 15mg, 25mg, 35mg and 50mg, with each dose group having 10 randomized patients (2 placebo, 8 on drug) per group. The trial demonstrated the following.

  • The total adverse events (AE) rate was identical vs. placebo with no relationship between AEs and incidence, types, intensity, or dose of drug. There were no severe AEs, deaths, or premature withdrawals due to AEs, and no significant laboratory, vital signs, or ECG abnormalities

  • Excellent linear correlation between drug dose and plasma exposure, dose-proportional AUC and Cmax across all 6 dose groups, no PK gender differences between male and female subjects, and no major metabolites were seen in plasma at the highest 50mg tested dose group

  • The dose proportional increases in post-meal insulin and GLP-1 levels were notably above placebo post-meal hormone levels, validating GK's pancreatic mechanism of action; dose proportional decreases in fasting glucose without hypoglycemia or significant changes in other regulatory hormones suggesting GK's hepatic MOA via reduction in gluconeogenesis at fasting state.

"In addition to the robust glucose and insulin responses, the substantial increase in post-meal GLP-1 levels demonstrated by HMS5552 at the higher doses was very gratifying to observe. No previous GKA in the clinic had shown significant effects on patient plasma GLP-1 levels, but our pre-clinical models suggested that HMS5552 could indeed increase GLP-1," stated CEO of Hua Medicine, Li Chen. "This effect appears to persist in our Phase 1a trials, and if confirmed in future trials would mark a significant advance in diabetes treatment, since GKA would be affecting most of the major glucose-regulation pathways in the body including insulin secretion, postprandial glucose control, hepatic glucose production, and GLP-1 modulation. We hope this multi-pathway targeting strategy will eventually lead to better, more effective therapies to control disease progression for all patients, but especially the subtype of earlier-stage diabetic patients most predominant in China and Asia."

As a follow-up to these positive Phase 1a trials, the company is now initiating a multicenter Phase 1b trial in diabetic patients that is expected to complete by 3Q-2014. The Phase 1b trial is a randomized, double-blind, placebo-controlled, multiple-ascending dose trial in 50 diabetic adult males and female patients. Daily doses will range from 25 mg to 200 mg (and up to 400 mg if needed) in the trial. In addition to evaluating HMS5552's safety, tolerability, and pharmacokinetics, the trial will evaluate the associated hormone biomarkers and pharmacodynamics of multiple oral doses of HMS5552 over a period of two weeks. These results are expected to further support HMS5552's novel mechanism of action and give guidance for trial design and optimal patient selection in future Phase 2 and Phase 3 trials.

Source: Marketwired News

Click here for the complete issue.

NEWS CRUNCH  
news EmTech Asia Opens: Features 50 speakers on innovation and emerging technologies
news Russia's only project to supply local high-tech anti-cancer drugs abroad continues with the first shipment to Vietnam
news Wheat Genome Sequencing Gets Major Boost
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  

Primates in Biomedical Research
COLUMNS  
\
APBN Editorial Calendar 2016
January:
Guest Editorial - Biotechnology In Korea
February:
Guest Editorial - Biomedical Research Governance
March:
Guest Editorial - Life-Saving Opportunities: A Guide to Regenerative Medicine
April:
Cancerology / Oncology
May:
Guest Editorial - Antibody Informatics In Japan
June:
Medical Devices and Technology
July:
Water Technology
August:
Occupational Health
September:
Olympics: Evolution of Sports
October:
Respiratory: Seasonal flu viruses
November:
Tobacco Smoking
Editorial calendar is subjected to changes.
– Editor: Carmen, Jia Wen Loh
MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Instructions to Authors
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» Editorial Enquiries: biotech_edit@wspc.com
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   Ms PoPo Kwok or Ms Sok Ching Lim/td>
Copyright© 2015 World Scientific Publishing Co Pte Ltd  •  Privacy Policy