2024.01.31
HONG KONG, SAR, January 31, 2024 /EINPresswire.com/ -- 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.
For more information, please visit https://fhltherapeutics.com.
