A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase III Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects with Diabetic Foot Ulcers

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

Start Date30 May 2023

Sponsor / Collaborator

Energenesis Biomedical Co., Ltd.

NCT04078555

/ RecruitingPhase 2

A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)

This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.

Start Date26 Jul 2022

Sponsor / Collaborator

Energenesis Biomedical Co., Ltd.

NCT03351322

/ CompletedPhase 2

A Randomized, Double-Blind, Active-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F701 Solution in Female Subjects With Hair Loss

The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.

Start Date23 May 2018

Sponsor / Collaborator

Energenesis Biomedical Co., Ltd.

[+1]

100 Clinical Results associated with Energenesis Biomedical Co., Ltd.

0 Patents (Medical) associated with Energenesis Biomedical Co., Ltd.

Literatures (Medical) associated with Energenesis Biomedical Co., Ltd.

26 Nov 2024·ANALYTICAL CHEMISTRY

Advancing Targeted Metabolomics Using Cyanopropyl-Based Liquid Chromatography Tandem Mass Spectrometry

Article

Author: Chen, Chin-Chen ; Lin, Jiun-Tsai ; Huang, Chun-Fang ; Liao, Wan-Rou ; Chen, Sung-Fang ; Chen, Han-Min ; Lin, Pei-Chen

The change of metabolic pathways is recognized as the key to disease discovery prompting the development of ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)-based quantitative platforms to explore the dynamic metabolite profiles of organisms. In this study, a liquid chromatography method based on cyanopropyl (CN) was developed. By adjusting the pH environment of the column, we achieved the elution of 51 metabolites spanning the most comprehensive set of biological pathways currently known. Offering rapid chromatography, efficient separation, and green chemistry benefits, the method encompasses nucleosides and nucleotides, the oxidative-redox metabolome, the glycolysis pathway, the pentose phosphate pathway, the purine de novo pathway, amino acids, and neurological disorder-related metabolites. The mass spectrometry was equipped with electrospray ionization in both positive and negative modes with scheduled multiple reactions monitoring. The validation of the method involved a comprehensive assessment of linearity, accuracy, precision, and matrix effect. The linear range was from 1.0 to 2000 ng mL^-1 with a high correlation coefficient (r > 0.99). The LOD ranged from 0.1 to 10 ng mL^-1, and the LOQ ranged from 0.1 to 25 ng mL^-1. The overall recovery ranged from 81.3% to 117.8%, with RSD < 15.1%. Subsequently, an analysis of metabolites was conducted in dSH-SY5Y neuroblastoma cells with 6-hydroxydopamine, a commonly used neurotoxin in neurodegenerative diseases. The results demonstrate that neurotoxin-induced mitochondrial damage significantly altered related analytes, corroborating previous estimates and validating the feasibility and reliability of the bioanalytical platform.

01 Sep 2022·EClinicalMedicine

ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial

Article

Author: Huang, Chieh-Huei ; Lin, Hwang-Chi ; Lin, Shang-Hsi ; Huang, Hui-Fu ; Liu, Tom J ; Lin, Yu-Hsien ; Young, Guang-Huar ; Yang, Hui-Mei ; Lin, Jiun-Tsai ; Chang, Hui-Hsiu ; Wang, Chih-Hsin ; Lin, Ying-Sheng ; Kuo, Ya-Chun ; Chang, Shun-Cheng ; Huang, Chun-Fang ; Yeh, Jiun-Ting ; Yang, Jui-Yung ; Hung, Shih-Yuan ; Chou, Chang-Yi ; Tzeng, Yuan-Sheng ; Cheng, Yi-Fang ; Chen, Cha-Chun ; Wei, Lin-Gwei ; Yang, Shih-Yi ; Chen, Han-Min ; Dai, Niann-Tzyy

Background:

Diabetic foot and leg ulcers are a major cause of disability among patients with diabetes mellitus. A topical gel called ENERGI-F703, applied twice daily and with adenine as its active pharmaceutical ingredient, accelerated wound healing in diabetic mice. The current study evaluated the safety and efficacy of ENERGI-F703 for patients with diabetic foot and leg ulcers.

Methods:

This randomized, double-blind, multicenter, phase II trial recruited patients from eight medical centers in Taiwan. Patients with intractable diabetic foot and leg ulcers (Wagner Grade 1-3 without active osteomyelitis) were randomly assigned (2:1) to receive topical ENERGI-F703 gel or vehicle gel twice daily for 12 weeks or until complete ulcer closure. The investigator, enrolled patients and site personnel were masked to treatment allocation. Intention to treat (ITT) population and safety population were patient to primary analyses and safety analyses, respectively. Primary outcome was complete ulcer closure rate at the end of treatment. This trial is registered with ClinicalTrials.gov, number NCT02672436.

Findings:

Starting from March 15^th, 2017 to December 26^th, 2019, 141 patients were enrolled as safety population and randomized into ENERGI-F703 gel (n = 95) group or vehicle gel (n = 46) group. In ITT population, ENERGI-F703 (n = 90) and vehicle group showed ulcer closure rates of 36.7% (95% CI = 26.75% - 47.49%) and 26.2% (95% CI = 13.86% - 42.04%) with difference of 9.74 % (95 % CI = -6.74% - 26.23%) and 25% quartiles of the time to complete ulcer closure of 69 days and 84 days, respectively. There were 25 (26.3%) patients in ENERGI-F703 group and 11 (23.9%) patients in vehicle group experiencing serious adverse events and five deaths occurred during the study period, none of them related to the treatment.

Interpretation:

Our study suggests that ENERGI-F703 gel is a safe and well-tolerated treatment for chronic diabetic foot and leg ulcers. Further studies are needed to corroborate our findings in light of limitations.

Funding:

Energenesis Biomedical Co., Ltd.

01 Jan 2020·International journal of medical sciencesQ3 · MEDICINE

Adenine inhibits growth of hepatocellular carcinoma cells via AMPK-mediated S phase arrest and apoptotic cascade

Q3 · MEDICINE

ArticleOA

Author: Lin, Jiun-Tsai ; Chen, Han-Min ; Kao, Shao-Hsuan ; Huang, Jen-Yu ; Su, Wei-Wen

Background: Adenine exhibits potential anticancer activity against several types of malignancies. However, whether adenine has anticancer effects on hepatocellular carcinoma (HCC) cells is incompletely explored. Methods: Human HCC cell lines HepG2 and SK-Hep-1 (p53-wild type) and Hep3B (p53-deficient) were used as cell model. Cell growth and cell cycle distribution were determined using MTT assay and flow cytometric analysis, respectively. Protein expression and phosphorylation were assessed by Western blot. Involvement of AMP-activated protein kinase (AMPK) was evaluated using specific inhibitor and small inhibitory RNA (siRNA). Results: Adenine treatments (0.5 - 2 mM) clearly decreased the cell growth of Hep G2 and SK-Hep-1 cells to 72.5 ± 3.4% and 71.3 ± 4.6% of control, respectively. In parallel, adenine also induced sub-G1 and S phase accumulation in both HCC cells. However, adenine did not affect the cell growth and cell cycle distribution of Hep3B cell. Western blot analysis showed that adenine reduced expression of cyclin A/D1 and cyclin-dependent kinase (CDK)2 and upregulated p53, p21, Bax, PUMA, and NOXA in HepG2 cell. Moreover, adenine induced AMPK activation that was involved in the p53-associated apoptotic cascade in HepG2 cells. Inhibition of AMPK activation or knockdown of AMPK restored the decreased cell growth of HepG2 and SK-Hep-1 cells in response to adenine. Conclusions: These findings reveal that adenine reduces the cell growth of HepG2 and SK-Hep-1 but not Hep3B cells, attributing to the AMPK/p53-mediated S phase arrest and apoptosis. It suggests that adenine has anticancer potential against p53-wild type HCC cells and may be beneficial as an adjuvant for HCC treatment.

News (Medical) associated with Energenesis Biomedical Co., Ltd.

11 Jun 2025

·www.prnewswire.com

Energenesis Biomedical to Unveil Promising Parkinson's Disease Therapy, ENERGI-F705PD, at BIO International 2025

TAIPEI, June 11, 2025 /PRNewswire/ -- Energenesis Biomedical Co., Ltd. (TWSE: 6657), a clinical-stage biotechnology company pioneering cellular energy restoration therapeutics, today announced its participation in the BIO International Convention 2025, taking place June 16–19 in Boston, MA. The company will be located at Booth #1645 within the Taiwan Pavilion, to showcase its innovative ENERGI Platform and provide a key update on its investigational Parkinson's disease (PD) therapy, ENERGI-F705PD, a first-in-class treatment with disease-modifying potential. Key Highlights: ENERGI-F705PD is a first-in-class, oral sustained-release therapy in development for Parkinson's disease, designed to address the underlying pathogenesis. Topline data from the Phase I trial in healthy subjects are anticipated in September 2025, following successful completion of recruitment. ENERGI-F705PD aims to combat the root causes of Parkinson's by reducing alpha-synuclein aggregation, enhancing antioxidant capacity, and boosting dopamine synthesis. "We are eager to present the exciting progress of our ENERGI-F705PD program at BIO International 2025," said Dr. Han-Min Chen, CEO of Energenesis Biomedical. "Parkinson's disease remains a challenging condition with significant unmet needs. Our approach focuses on restoring cellular energy and combating critical pathogenesis of PD, offering a potential disease-modifying solution for patients. We look forward to sharing our latest data and exploring potential partnerships that can accelerate the development of this important therapy." About ENERGI-F705PD ENERGI-F705PD is a novel small-molecule drug delivered in an oral sustained-release formulation. It is designed to enhance cellular ATP and antioxidant production by engaging the purine salvage, glycolysis, and pentose phosphate pathways. This multi-pronged mechanism of action directly addresses key pathological hallmarks of Parkinson's disease: Reduce and Prevent α-Synuclein Aggregation: Elevated ATP acts as a hydrotrope, helping prevent the intracellular aggregation of misfolded α-synuclein, a central pathogenic hallmark of PD. Increase Reducing Power (antioxidant): ENERGI-F705PD upregulates the pentose phosphate pathway (PPP), leading to increased NADPH production and enhanced cellular antioxidant defense. Increase Tyrosine Hydroxylase Expression/activity: By optimizing cellular energy metabolism and engaging the purine salvage pathway, ENERGI-F705PD also enhances the expression and activity of tyrosine hydroxylase (TH), the key enzyme in dopamine synthesis, thereby helping restore neurotransmitter levels in the brains of PD patients. About Energenesis Biomedical Energenesis Biomedical Co., Ltd. (TWSE: 6657) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics that restore cellular energy and activate intrinsic repair mechanisms. By combining proprietary small-molecule innovation with AI-driven drug repurposing, Energenesis Biomedical aims to accelerate the development of treatments for unmet medical needs across various therapeutic areas, including neurodegenerative diseases, chronic wounds, and rare disorders. The company's robust pipeline includes: ENERGI-F705PD: Oral tablet for Parkinson's disease (Phase I) ENERGI-F703DFU: Gel for Diabetic foot ulcers (Phase III) ENERGI-F701: Tonic for Alopecia (Phase II completed) ENERGI-F703EB: Cream for Epidermolysis bullosa (EB), granted FDA Orphan Drug and Rare Pediatric Disease designation, and EMA orphan designation(Preparing for Phase II) For more information, please visit Contact: Business Development Team Email: [email protected] SOURCE ENERGENESIS BIOMEDICAL CO., LTD. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Orphan DrugPhase 2Cell Therapy

100 Deals associated with Energenesis Biomedical Co., Ltd.

100 Translational Medicine associated with Energenesis Biomedical Co., Ltd.

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Pipeline Snapshot as of 27 Jun 2025

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

ENERGI-F703 ( AMPK )	Diabetic foot ulcer More	Phase 3
ENERGI-F705PD ( TYH )	Parkinson Disease More	Phase 1
ENERGI-F710	Hyperphosphatemia More	Preclinical
Adenine ( A1R x A2aR x A3R )	Epidermolysis Bullosa More	Preclinical
ENERGI-F701 ( AMPK )	Baldness, Female Pattern More	Pending

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