On October 11, Energenesis Biomedical announced the signing of an exclusive licensing agreement with Pharma Bavaria International Group (PBI). This agreement grants PBI the rights to commercialize ENERGI-F703 for the treatment of diabetic foot ulcers (DFU) in the Portuguese and Middle Eastern markets. PBI, a well-established pharmaceutical company, markets products in more than 45 countries, including Europe, the Middle East, Africa, Southeast Asia, the Commonwealth of Independent States (CIS), and Latin America. PBI's portfolio spans therapeutic areas such as oncology, cardiovascular diseases, and infectious diseases, and it has a strong presence in Portugal, the Middle East, and other emerging markets.
Currently, the only FDA-approved drug for the treatment of DFU is Regranex®, which holds less than 1% of the market share, indicating substantial growth potential in the future.
According to Grand View Research, the global hard-to-heal wound market is projected to exceed $700 million by 2027 in key Middle Eastern countries such as Saudi Arabia, the UAE, Israel, Iran, and Turkey. If Energenesis' product achieves a 10% market share after its launch, it could capture more than $70 million in the hard-to-heal wound market.
Energenesis’ F703 is currently in Phase 3 clinical trials in both the U.S. and Taiwan, with the trials expected to conclude next year. The company is optimistic about the results and plans to apply for drug approval from Taiwan's FDA following the completion of the trials.
In addition to F703, Energenesis has submitted an application to Taiwan’s Ministry of Health and Welfare (TFDA) to conduct Phase 1 clinical trials for its oral Parkinson's disease treatment, ENERGI-F705PD. This marks the company’s third clinical trial, following its Phase 3 trial for F703 and a Phase 2 trial for preventing abnormal hair loss.
Parkinson’s disease, the second most common neurodegenerative disorder after Alzheimer’s disease, is caused by a deficiency of the neurotransmitter dopamine. Current treatments primarily focus on enhancing dopamine function, which addresses symptoms but does not provide a cure. Energenesis aims to increase cellular energy through the activation of ATP using its proprietary ENERGI, thereby promoting self-healing in damaged cells.
WHO data indicates that the global Parkinson’s disease population has doubled over the past 25 years. As of 2019, more than 8.5 million people worldwide are affected by Parkinson’s, with 5.8 million living with severe disability. The disease's severity continues to worsen over time.
Energenesis' preclinical studies on Parkinson’s disease have shown that its treatment can increase ATP levels in nerve cells. Animal studies also demonstrated an increase in mitochondrial count in microglial cells, along with a boost in intracellular ATP, suggesting promising outcomes. Energenesis' innovative approach of enhancing ATP production to boost cell energy is further supported by the Max Planck Institutes in Germany, which have validated the scientific basis of F705PD as a potential biological solvent for ATP.
Currently, most Parkinson’s treatments focus on replacing the missing dopamine in patients' brains. In contrast, Energenesis' F705PD has been found to increase the expression of tyrosine hydroxylase, reducing the buildup of harmful proteins. This not only outperforms current symptom-based treatments but may also delay the progression of Parkinson's from stage 1 to stage 5, potentially reducing patients' reliance on medication.
Energenesis expects to achieve Phase 1 clinical trial results for F705PD soon and aims to apply for Phase 2 trials in the U.S. by mid-2025. With scientific backing from the Max Planck Institutes, the company believes that F705PD could significantly reduce the burden of Parkinson's disease on patients.
Additionally, Energenesis' F705AD, an Alzheimer’s disease treatment, has shown promising results in animal studies. The company is confident about its future prospects and plans to accelerate its FDA application for Phase 2 clinical trials for F705AD after completing Parkinson's Phase 2 trials.
Both Alzheimer’s and Parkinson’s diseases share the characteristic of progressive deterioration, leading to significant suffering for patients and their caregivers. Current medical treatments can only alleviate symptoms and do little to slow disease progression. As the global population ages, the number of affected individuals is expected to rise dramatically.
If Energenesis succeeds in developing its Parkinson's and Alzheimer's treatments, it could greatly reduce the physical and emotional toll on patients and their families, offering a better quality of life for the elderly.
Resource (mandarin): 華安醫學授權德國知名藥廠PBI集團共同開發葡萄牙及中東DFU市場
