Energenesis Biomedical Announces Positive Phase I Results for ENERGI-F705PD, a Potential Disease-Modifying Treatment for Parkinson's Disease

• The Phase I trial of ENERGI-F705PD tablet was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of the investigational drug in 24 healthy subjects.
• The results confirmed the favorable safety and tolerability profile of ENERGI-F705PD and successfully validated its sustained-release oral formulation.
• Energenesis plans to advance ENERGI-F705PD into a Phase II trial.

TAIPEI, Aug. 1, 2025 /PRNewswire/ -- Energenesis Biomedical Co., Ltd. (TWSE: 6657), a clinical-stage biotechnology company focused on cellular energy restoration therapeutics, today announced the successful completion of its Phase I clinical trial for ENERGI-F705PD, an oral investigational drug candidate for Parkinson's disease (PD). The Phase I study demonstrated favorable safety and tolerability in healthy volunteers, marking a significant milestone in the development of ENERGI-F705PD and reaffirming its potential as a disease-modifying therapy that targets intracellular alpha-synuclein aggregation. Energenesis Biomedical plans to submit a Phase II clinical trial application in 2025 to further evaluate the therapeutic efficacy of ENERGI-F705PD in patients with Parkinson's disease.

"Current treatments for Parkinson's disease primarily target symptoms, while ENERGI-F705PD represents a novel therapeutic strategy with disease-modifying potential," said Dr. Han-Min Chen, CEO & Founder of Energenesis Biomedical. "ENERGI-F705PD targets Parkinson's disease by restoring cellular energy ATP levels, preventing cellular alpha-synuclein aggregation, and decreasing ROS levels for neuroprotection. This multi-pronged approach may significantly slow disease progression. The encouraging results from our Phase I trial bring us one step closer to delivering a meaningful treatment option for PD patients worldwide."

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 Alpha-synuclein Aggregation: Elevated ATP acts as a hydrotrope, helping prevent the intracellular aggregation of misfolded alpha-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.

The Promise of Alpha-Synuclein Targeting in Parkinson's Disease

Parkinson's disease, affecting over 10 million people globally, currently has no cure, with existing treatments only managing symptoms. The accumulation of alpha-synuclein protein is a key hallmark of the disease, making it a highly promising target for new disease-modifying therapies that aim to fundamentally change its progression. This critical area is seeing significant research and development, including both small molecules and antibody-based investigational treatments. ENERGI-F705PD, as an oral small-molecule drug, offers key advantages over antibody therapies, including better blood-brain barrier penetration, convenient oral administration, direct intracellular targeting, and potentially more accessible manufacturing.

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 leading candidates include:

• ENERGI-F705PD: Tablet for Parkinson's disease (Preparing for Phase II)
• 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 www.energenesis-biomedical.com/en

Contact: Business Development Team

Email: [email protected]

SOURCE ENERGENESIS BIOMEDICAL CO., LTD.