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before we create

we listen.

before we create

we listen.

Patients, and what they are living with, are at the center of everything we do. We want to take 
therapeutic-experience-driven development to a new level.  We make sure we stay in constant touch with patients and physicians through all stages of development, with their insights transforming how we define both the questions and the answers.

A rich portfolio of smart pinpoint solutions

Our pipeline is defined by major unmet needs and is aimed at helping patients regain a sense of balance, health, and a life worth living.

patient’s despair.

our commitment.

Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. The efficacy rates of most common treatments are low, with about 30% of patients with major depressive Disorder failing to respond to currently available antidepressants.

I don’t feel happiness and sadness, I don’t feel anything, I just don’t have enough energy to do the basic. I don’t want to talk with people, my energy disappear so fast and I want to go home, for my bed, for my computer.” (Patients forum 2017)

Clexio is developing CLE-100, an oral NMDA modulator, as an adjunctive treatment for patients suffering from Major Depressive Disorder with an inadequate response to anti-depressant treatments.

 

 

The onset of action for currently available antidepressants is typically 4 to 6 weeks. This lag, as well as a high non-response rate, underscores the need for new antidepressant medications.

patient’s pain.

our commitment.

Pain is a complex condition that affects more people than diabetes, heart disease and cancer combined.

“It is difficult for family, friends, and even your work associates to understand when you can never commit to any long-term plans, as you never know when your pain will flare up leaving you incapacitated.” (from FDA report “The Voice of the Patient” February, 2017)

At Clexio, we are developing a portfolio of novel non-opioids treatments to address various pain conditions, and to provide comfort, relief, and safety for pain sufferers. We are using well established mechanisms of action, and focusing on topical delivery in order to minimize systemic side effects.

 

Alleviating Painful Diabetic Neuropathy

Painful Diabetic Neuropathy (PDN) is a common and disabling complication of diabetes, and affect millions of people with around quarter of people with diabetes suffering from PDN. It involves symptoms of generally severe pain in a ‘glove-and-stocking’ distribution, usually beginning in the feet. 

It is hell to live with and is hard to treat. Currently approved drugs show treatment response in less than half of the patients.

Topical treatments are designed to bring relief to where it is needed. It also helps avoid many of the possible side affects and drug interactions issues of tablets or injections. This is particularly important for the diabetic population, which often suffers from cardiovascular comorbidities and uses multiple drugs. Currently there are no FDA approved topical treatments for PDN.

At Clexio, we are developing CLE-400, a topical formulation, about to enter clinical stage development, on the alpha 2 agonist Detomidine, for the treatment of Painful Diabetic Nauropathy.

Easing Cluster headaches

Cluster headaches, which occur in cyclical patterns or clusters, are one of the most painful types of headache. Cluster Headaches are characterized by intense and severe head pain that can lead to suicidal tendencies, at times called “the most painful conditions known to mankind”. A cluster headache commonly awakens patients in the middle of the night with intense pain in or around one eye on one side of their head. Bouts of frequent attacks, known as cluster periods, can last from weeks to months, usually followed by remission periods when the headaches stop.

CLE-500 is being developed as a patient-controlled drug-device combination for the immediate relief of cluster headaches. 

clexio technology

platform

for oral long-acting drugs

Clexio is developing a Novel Oral Long Acting Release (OLAR®) platform designed for continuous drug delivery to the GI tract allowing for more efficient drug absorption and lower drug plasma fluctuations, targeting therapeutic drug levels for 8 – 24 hours, under fast and fed conditions.

 

pipeline

Program & Indication

Pre clinical

Phase 1

Phase 2

Phase 3

CLE-100

Major Depressive Disorder (MDD) is a common and serious mental health condition affecting ~5% of the global population. Despite the availability of many antidepressant drugs, 1 in 3 patients suffering from MDD does not achieve remission following several treatment trials with antidepressant medications.

Clexio is on a mission to change this and is committed to finding an effective treatment for patients suffering from MDD, with an emphasis on patients who fail to respond to currently available treatments.

CLE-100 is an oral NMDA receptor antagonist, which is being developed by Clexio as an adjunctive treatment for patients suffering from MDD who inadequately respond to anti-depressant treatments.

CLE-100 is currently being tested in the CLEO study, a two part Phase 2 study conducted in the US.

We completed Part A of the CLEO study, which assessed the safety profile of CLE-100 given daily for one week to MDD patients.

Based on the results from Part A, we are now enrolling for Part B of the study.

CLEO Part B is a randomized, double-blind, placebo-controlled, multicenter Phase 2 trial of CLE-100 as an adjunct therapy in subjects with Major Depressive Disorder with inadequate response to standard antidepressant therapy. Approximately 120 patients will be randomized to receive CLE-100 or placebo for 4 weeks. Patients will be assessed throughout the study using different measures including safety parameters, the Montgomery-Åsberg Depression Rating Scale (MADRS), other clinician-rated scales, as well as patient-reported outcome measures.

 

CLE-600

Parkinson’s disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease, with US prevalence estimated at ~1,000,000 individuals with Parkinson, growing due to aging population. Parkinson’s disease occurs when dopamine- producing nerve cells in an area of the brain that controls movement die,  resulting in a reduced production of dopamine, which causes the movement problems characteristic to Parkinson’s. Thus, Parkinson’s disease symptoms include stiffness, tremors and difficulty with balance and coordination occurring during the day and at night.

One of the common struggles for Parkinson’s patients is troubled nights and morning akinesia.

Nocturnal symptoms and Early Morning Akinesia (EMO) are estimated to be prevalent in more than 60% of Parkinsonian patients, having a negative impact on patients’ quality of life and daytime function. Current available dopaminergic treatments do not cover the duration and levels required for clinical efficacy over the entire night. 

Clexio is developing CLE-600, a night pill for the treatment of Parkinson’s disease nocturnal symptoms and Early Morning OFF.

CLE-600 uses Clexio’s proprietary Oral Long Acting Release (OLAR®) drug delivery platform. The development is designed to achieve stable and prolonged levels of Levodopa, aiming to enable Parkinson patients symptomatic control during the night and into the early morning.

Clexio conducted Phase 1 studies with CLE-600 in order to check safety and tolerability and Pharmacokinetic profile under food and fast conditions. The administration of CLE-600 was safe and well tolerated, and a prolonged pharmacokinetic profile was achieved.

Clexio is progressing the program into the next clinical phase.

CLE-400

CLE-400 is a novel topical treatment which is being developed for painful peripheral neuropathies and certain types of chronic pruritus, disease areas with a significant unmet need and high prevalence.

Globally, there are 442 million patients suffering from neuropathic pain. Chronic neuropathic pain is a condition that negatively affects sleep, mood and functionality, resulting in a low quality of life and a significant economic burden. Less than half of patients with neuropathic pain respond to current treatments. Most approved medications have multiple systemic side effects typically resulting in low tolerance from patients, and more than 30% of neuropathic pain patients use opioids for pain relief.

Clexio is working to alleviate pain in patients suffering from peripheral neuropathic pain.

CLE-400 contains Detomidine, a potent α2-adrenergic agonist molecule with additional relevant modalities. The molecule is both a non-opioid and a non-steroid.

Clexio is developing a unique gel formulation for CLE-400, which enables maximal skin penetration while limiting the systemic exposure and by creating a depot under the skin, aiming for long lasting effect and once daily administration.

To date, CLE-400 pharmacological effects have been tested in different validated pharmacological models of painful peripheral neuropathies, post-operative-pain and pruritus. These studies compared CLE-400’s effect to placebo and positive controls, in both large and small animals and in both acute and chronic settings. All the animal models showed that CLE-400 had a fast onset of action with 1 day of treatment; and that the cumulative analgesic effect was shown with repeated dosing.

GLP Toxicity and Genotoxicity studies have been completed to support First-In-Human Phase 1 studies. CLE-400 was well tolerated in the relevant animal species and was shown to be not genotoxic.

Three doses of CLE-400 are currently being tested in Phase 1 studies.

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CLE-300

Coming Soon

CLE-500

CLE-500 is being developed as a self-administrated intra-nasal drug-device combination product for the immediate relief of cluster headache attacks.

CLE-400

CLE-400 is a novel topical treatment which is being developed for certain types of chronic Pruritus (itch) and for painful peripheral neuropathies, disease areas with a significant unmet need and high prevalence.

Chronic pruritus is a debilitating condition associated with a markedly reduced quality of life. Deranged sleep patterns and mood disturbances, including anxiety and depression, are common and may exacerbate the itching.  23-44 million Americans suffer from Chronic Pruritus due to cutaneous or systemic conditions.  To date, there are no approved drugs in the US for the treatment of chronic pruritus associated with any disease. 

Clexio is aiming to alleviate itching for patients suffering from localized chronic Pruritus.

CLE-400 contains Detomidine, a potent α2-adrenergic agonist molecule with additional relevant modalities. The molecule is both a non-opioid and a non-steroid.

Clexio is developing a unique gel formulation for CLE-400, which enables maximal skin penetration while limiting systemic exposure and by creating a depot under the skin, aims for a long lasting effect and once daily administration.

To date, CLE-400 pharmacological effects have been tested in different validated pharmacological models of pruritus, painful peripheral neuropathies and post-operative-pain. These studies compared CLE-400’s effect to placebo and positive controls, in both large and small animals and in both acute and chronic settings. All the animal models showed that CLE-400 had a fast onset of action. In the itch model, CLE-400 at all 3 doses effectively blocked itch from 5 minutes after application.

GLP Toxicity and Genotoxicity studies have been completed to support First-In-Human Phase 1 studies. CLE-400 was well tolerated in the relevant animal species and was shown to be not genotoxic.

Three doses of CLE-400 are currently being tested in Phase 1 studies.

OLAR®

Clexio’s proprietary Oral Long Acting Release (OLAR®) platform is designed for continuous drug delivery to the GI tract, allowing for more efficient drug absorption and lower drug plasma fluctuations.

It targets therapeutic drug levels for 8 – 24 hours.

OLAR® is administered orally and is non-invasive. It is a versatile platform, suitable for multiple APIs and enabling high drug loading (up to total of 750 mg drug and excipients loading).

The OLAR® is designed to be swallowed in a folded configuration, within a capsule. After swallowing, the OLAR® unfolds to a triangle with a size bigger than average pylorus allowing it to be retained in the stomach while releasing its inner formulation (multiple tablets). After the formulation’s dissolution, the OLAR® disassembles to parts smaller than the pyloric size, empties from the stomach and softens/degrades in the intestines.

Clexio conducted Phase 1 studies with OLAR® in order to check safety and tolerability, gastric retention and Pharmacokinetic profile: the administration of OLAR® was safe and well tolerated, and a prolonged pharmacokinetic profile was achieved.

For more details, please watch the OLAR® animation movie.

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