(MENAFN- EIN Presswire) HONG KONG, SAR, January 31, 2024 /EINPresswire / -- Forest Hills Lab (“FHL”), an innovative global life sciences company focused on regenerative medicine and medical aesthetics, announces successful completion of Phase 1 clinical trial for FHL-101 (Glyceryl Tribenzoate) as a potential treatment for neurodegenerative conditions, including Parkinson's Disease.
The study met its primary objective to evaluate the safety and tolerability of single and multiple oral escalating doses of FHL-101 in healthy subjects. Results from the single-ascending dose phase (n=24) and multiple ascending dose phase (n=20) indicated no clinically significant changes in laboratory parameters, physical examination results, vital signs, or ECG findings for healthy subjects. With a full compliance rate with treatment administration, FHL-101 demonstrated to be safe and well tolerated with no serious adverse events, and no treatment-related adverse events were reported over the course of the study.
“We are excited to have marked an important milestone in FHL-101's clinical development. The completed Phase 1 study underscored FHL-101's tolerability, while also demonstrating an excellent safety profile,” says Shrijay Vijayan, PhD, FHL's Chief Scientific Officer.“Given the highly encouraging Phase 1 results, we look forward to rapidly advancing FHL-101's clinical development. We have deep confidence in the strong scientific basis for FHL-101's mechanism of action. and its ability to protect neurons and attenuate inflammation in the brain.”
“We are very pleased with the encouraging Phase 1 clinical trial results, clearly demonstrating FHL-101's positioning to serve as a high potential drug candidate to treat devastating neurological disorders,” says Alex Yang, Chairman and CEO of Forest Hills Lab.“Parkinson's disease continues to represent an extraordinary burden on patients and their families. With the successful completion of FHL-101's Phase 1 clinical trial, our team is currently evaluating and optimizing our planned Phase 2 clinical study design and patient population.”
About FHL-101 Phase 1 Clinical Trial
The Phase 1 clinical trial is a two-part placebo-controlled, double-blind study of FHL-101 in healthy subjects. The first part of the study involved a total of 24 healthy subjects enrolled into the single-ascending dose phase, followed by the second part of the study with 20 healthy subjects participating in the multiple ascending dose phase. The primary objectives were to evaluate safety and tolerability of single and multiple oral escalating doses of GTB in healthy patients. The secondary objectives were to evaluate pharmacokinetic and pharmacodynamic profiles of FHL-101.
About FHL-101
FHL-101 is a novel small molecule drug, composed of Glyceryl Tribenzoate (GTB), under investigation for oral treatment of neurodegenerative conditions, such as Parkinson's Disease. FHL-101 promotes the generation of Glial cell-line Derived Neurotrophic Factor (GDNF), a key protein that supports neuron function, suppresses inflammation and prevents neuronal death in Parkinson's Disease and other neurodegenerative conditions.
About Forest Hills Lab
Forest Hills Lab is an innovative global life sciences company focused on regeneration and committed to improving well-being in our rapidly aging society. FHL is comprised of three divisions: the Therapeutics division, Aesthetics division, and Awakening Health Lab. FHL's Therapeutics division is a US-focused therapeutic platform seeking to develop drugs to treat neurodegenerative diseases with high unmet need. FHL's Aesthetics division, deep-rooted in American culture and technology, develops and markets a comprehensive line of medical- and non-medical grade aesthetics products globally with Korean R&D and manufacturing excellence and principal offices in US, Korea, Hong Kong, and Singapore. FHL's Awakening Health Lab division leverages cutting-edge AI robotics technology to improve the healthcare service experience for the aesthetic clinic industry.
Forest Hills Lab's largest shareholder is Mstone Partners, an entrepreneurial biotech incubator in the form of a holding company which owns and manages a portfolio of drug development companies. Mstone focuses on pediatric and repurposed drugs, rare and neurodegenerative diseases, and innovative technologies for targeted indications. Since its inception in 2016, Mstone has invested in two US and one HK companies, which are now in advanced clinical stages with the US FDA. Mstone has also established several portfolio companies under the Curestone Platform, which manages a portfolio of drug development companies in a centralized, hub-and-spoke model.
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