Privacy Policy

FHL Therapeutics Website Privacy Policy


Forest Hills Partners (“us”, “we”, or “our”) operates https://fhltherapeutics.com/ (the “Website”).
We are committed to ensuring that your privacy is protected and this page informs you of our policies regarding the collection, use and disclosure of Personal Information we receive from users of the Website. If you are asked to provide information when using the Website, it will only be used in the ways described in this privacy policy.
By using the Site, you agree to the collection and use of information in accordance with this policy.



Information Collection


While using the Website, we may ask you to provide us with certain personally identifiable information. Personally identifiable information may include, but is not limited to your name, address, email address, contact number (“Personal Information”).
By using the Site, you agree to the collection and use of information in accordance with this policy.



Use of Information


We use this information in order to provide products and services, to enable certain functions on the Website and to understand your needs and provide you with a better service, and in particular for the following reasons:


• To complete order/s purchased via the Website, and to process your payments

• To improve our products and services we provide

• To customize the Website for you. Internal record keeping, and administrative purposes

• To contact you in response to specific enquiry



Cookies


Cookies are files with small amount of data, which may include an anonymous unique identifier. Cookies are sent to your browser from a web site and stored on your computer’s hard drive. Like many sites, we use “cookies” to collect information. You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Site.



Security


The security of your Personal Information is important to us, but remember the internet is not a secure medium. However, we take reasonable technical and organizational precautions to prevent the loss, misuse or alteration of your personal information.



Changes to This Privacy Policy


This Privacy Policy is effective as of December 1, 2023 and will remain in effect except with respect to any changes in its provisions in the future, which will be in effect immediately after being posted on this page. We reserve the right to make changes to this privacy policy from time to time and you should check this Privacy Policy periodically. Your continued use of the Website after we post any modifications to the Privacy Policy on this page will constitute your acknowledgment of the modifications and your consent to abide and be bound by the modified Privacy Policy.



Contact Us


If you have any questions about this Privacy Policy, please contact us at +852 2155 0487 or email us at info@foresthillslab.com.

Terms & Conditions

FHL Therapeutics Website Privacy Policy


Forest Hills Partners (“FHP”) owns and operates this website (https://fhltherapeutics.com/). (This document governs your relationship with our website. These Terms and Conditions (the “Terms”) contained herein on this webpage, shall govern your use of the website, including all pages within this website (the “Website”). The Terms apply in full force and effect to your use of the Website and by accessing the Website, you agree to be bound by the Terms contained herein in full. You must not use the Website, if you disagree with any part of the Terms.



Age Restriction


You must be at least 18 years of age to use the Website; by using the Website or agreeing to the Terms, you warrant and represent to us that you are at least 18 years of age.



Intellectual Property Rights


The intellectual property rights in all software and content (including photographic images) made available to you on or through the Website remains the property of FHP or its licensors and are protected by copyright laws and treaties around the world. All such rights are reserved by FHP and its licensors. You may store, print and display the content supplied solely for your own personal use. You are not permitted to publish, manipulate, distribute or otherwise reproduce, in any format, any of the content or copies of the content supplied to you or which appears on the Website nor may you use any such content in connection with any business or commercial enterprise.



Coockies


Cookies are files with small amount of data, which may include an anonymous unique identifier. Cookies are sent to your browser from a web site and stored on your computer’s hard drive. Like many sites, we use “cookies” to collect information. You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Site.



Prohibitions


You are expressly and emphatically restricted from all of the following: publishing any the Website material in any media; selling, sublicensing and/or otherwise commercializing any the Website material transmit or distribute a virus, trojan, worm, logic bomb or any other material which is malicious, technologically harmful, in breach of confidence or in any way offensive or obscene; using the Website in any way that impacts user access to the Website; engaging in any data mining, data harvesting, data extracting or any other similar activity in relation to the Website, or while using the Website; send any unsolicited advertising or promotional material, commonly referred to as “spam”;
Breaching this provision would constitute a criminal offense and FHP will report any such breach to the relevant law enforcement authorities and disclose your identity to them.
We will not be liable for any loss or damage caused by a distributed denial-of-service attack, viruses or other technologically harmful material that may infect your computer equipment, computer programs, data or other proprietary material due to your use of the Website or to your downloading of any material posted on it, or on any the website linked to it



No Warranties


The Website is provided “as is,” with all faults, and FHP makes no express or implied representations or warranties, of any kind related to the Website or the materials contained on the Website. Additionally, nothing contained on the Website shall be construed as providing consult or advice to you.



General Conditions


We reserve the right to refuse service to anyone for any reason at any time



Intellectual Property Rights


The intellectual property rights in all software and content (including photographic images) made available to you on or through the Website remains the property of FHP or its licensors and are protected by copyright laws and treaties around the world. All such rights are reserved by FHL and its licensors. You may store, print and display the content supplied solely for your own personal use. You are not permitted to publish, manipulate, distribute or otherwise reproduce, in any format, any of the content or copies of the content supplied to you or which appears on the Website nor may you use any such content in connection with any business or commercial enterprise.



Disclaimer of Liability


In no event shall FHP, nor any of its officers, directors and employees, be liable to you for anything arising out of or in any way connected with your use of the Website, whether such liability is under contract, tort or otherwise, and FHP including its officers, directors and employees shall not be liable for any indirect, consequential or special liability arising out of or in any way related to your use of the Website.



Indemnity


You agree to indemnify, defend and hold harmless FHP, its directors, officers, employees, consultants, agents, and affiliates, from and against any and all liabilities, costs, demands, causes of action, damages and expenses (including reasonable attorney’s fees) arising out of or in any way related to your breach of any of the provisions of the Terms.



Variation


FHP shall have the right in its absolute discretion at any time and without notice to amend, remove or vary the Website and/or any page of the Website. You should check this page regularly to take notice of any changes we may have made to the Terms.



Invalidity


If any provision of the Terms is found to be unenforceable or invalid under any applicable law, such unenforceability or invalidity shall not render the Terms unenforceable or invalid as a whole, and such provisions shall be deleted without affecting the remaining provisions herein.



Complaints


We operate a complaint handling procedure which we will use to try to resolve disputes when they first arise, please let us know if you have any complaints or comments through +852 2155 0487 or info@foresthillslab.com.



Waiver


If you breach these conditions and we take no action, we will still be entitled to use our rights and remedies in any other situation where you breach the Terms.



Entire Agreement


The above terms, including any legal notices and disclaimers contained on the Website, constitute the entire agreement of the parties and supersede any and all preceding and contemporaneous agreements between you and FHP, and supersede all prior agreements and understandings with respect to the same.

Our Pipeline
Clinical Trials

FHL-101

A phase 1, randomized, double-blind, single-dose escalation study
followed by a multiple-dose escalating study of Glyceryl Tribenzoate (GTB)
capsules in healthy subjects

For more information, please go to clinicaltrials.gov
01

Design

  • A two-part (single ascending dose and multiple ascending dose)
    placebo-controlled, double-blind study
  • Number of volunteers in the single ascending dose phase: 24
  • Number of volunteers in multiple ascending dose phase: 20
02

Patient Population

Inclusion criteria

  • Healthy participants 18 to 50 years of age inclusive with body mass index (BMI) ≥ 18 kg/m² and ≤ 30 kg/m²
  • Participants must not be pregnant or lactating at screening, and take adequate method of contraception from Screening until 30 days
    after last dose of study medication
  • Negative for SARS-CoV-2 virus at admission Day -1 and Day 1 (during the SAD, Fed portion of the study, and MAD)
  • Participant does not have dysphagia and discomfort with swallowing tablets/capsules

Exclusion criteria

  • Use of any investigational product or device within 30 days prior to enrollment or during the study
  • Use of prescription or over-the-counter medications within 2 weeks of enrollment (excluding hormonal contraceptives and acetaminophen)
    unless deemed acceptable by the Investigator in consultation with the Sponsor
  • A positive drug and/or alcohol test at Screening and on Day – 1 or has a history of drug or alcohol abuse within 2 years before Screening
  • Unable to abstain from ingesting alcohol or smoking for 72 hours prior to dosing and throughout the study
  • Concurrent use of probenecid, penicillin or other ß-lactams, or other drugs which undergo active tubular secretion in the kidneys
  • A clinically significant history of endocrinologic, hematologic, hepatic, immunologic, metabolic, cardiovascular, urologic, pulmonary, neurologic,
    dermatologic, psychiatric, renal, and/or other major diseases or malignancy
  • Allergy to sodium benzoate
  • Has an active suicidal plan/intent or thoughts in the past 6 months or a suicide attempt in the past 3 years
03

For both part A (single ascending dose)

and part B (multiple ascending dose)

Primary endpoints

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) until 30 days after the last administration of the study medication
  • Incidence of TEAEs leading to withdrawal of study drug or study discontinuation
  • Change from baseline in clinical laboratory results
  • Change from baseline in physical examination results
  • Change from baseline in vital signs
  • Change from baseline in 12-lead electrocardiogram
  • Change from baseline at each scheduled visit in the Columbia-suicide severity rating scale (C-SSRS). (Part B only)

Secondary endpoints

  • PK parameters derived from plasma concentrations of GTB and Benzoic Acid
  • PD markers in Plasma and Urine will be described in the PK/PD SAP including but not limited to the amount and percent excreted of hippuric acid
    in relative to dose

Single Ascending Dose Phase

  • 01

    SCREENING

    28 days
    n=24

  • 02

    TREATMENT

    Part A
    1 day fasting + 3 days in confinement

    Washout period for patients
    participating in part B

    Part B
    1 day fed (high-fat meal)
    + 3 days in confinement

  • 03

    FOLLOW-UP

    14 days and
    30 days post-dose

Multiple Ascending Dose Phase

  • 01

    SCREENING

    28 days
    n=16

  • 02

    TREATMENT

    7 days treatment exposure
    + 3 days in confinement

  • 03

    FOLLOW-UP

    14 days and
    30 days post-dose

FHL-301

A phase 2, double-blind, multi-center, placebo-controlled clinical study of Gemfibrozil

For more information, please go to clinicaltrials.gov
01

Design

  • Conducted in the USA and Asia
  • No. of patients: 32 (planned)
  • Randomization of FHL-301:Placebo = 1:1
02

Patient Population

Inclusion criteria

  • Patients with confirmed diagnosis of Parkinson’s disease, age 40-75 years old
  • Patients must not be pregnant of lactating at screening, and take adequate contraception methods throughout the study
  • Patients who are treatment naive or have history of prior incidental treatment with dopaminergic agents for no more than 30 days
  • Patients with Hoehn and Yahr Stage of 1.0 and 2.0 at screening

Exclusion criteria

  • Patients with unclear diagnosis or with presence of secondary Parkinsonism or other neurodegenerative diseases
  • Patients with significant unstable conditions or any health condition that may be deemed inappropriate to take part in the trial
  • Patients who are taking medications that are contraindicated for use with FHL-301
03

For both part A (single ascending dose)

and part B (multiple ascending dose)

Primary endpoints

  • Change from Baseline in the MDS UPDRS Part III at maintenance Week 48

Secondary endpoints

  • Occurrence of Treatment Emergent Adverse Events
  • Changes from baseline to maintenance (Week 48) in physical exam, vital signs, Columbia Suicide Severity Rating Scale (C-SSRS) and laboratory assessments
  • Change from baseline at each scheduled assessment during the titration and maintenance period in 12-lead electrocardiogram (ECG)

Total Study Duration : 51 weeks

  • 01

    SCREENING

    Before Treatment Period

    n=32

    Hoehn and Yahr
    Stage of 1.0 to 2.0

  • 02

    TITRATION

    3 weeks

    FHL-301 dose escalation

    Escalated on weekly basis
    until maximum tolerated dose

  • 03

    MAINTENANCE

    48 weeks

    Use maximum tolerated dose
    from titration period

    Perform efficacy evaluation regularly

    Perform safety evaluation
    throughout the study