before we create
before we create
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.
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.
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.
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.
Program & Indication
CLE-100 is an oral NMDA modulator developed as an adjunctive treatment for patients suffering from Major Depressive Disorder with an inadequate response to anti-depressant treatments.
Started part A of Phase 2 study in MDD patients in the US.
CLE-400 is a novel, proprietary, topical gel formulation of the α2 adrenergic receptor agonist detomidine.
Initial focus on topical treatment of Painful Diabetic Neuropathy (PDN), with potential for additional pain conditions.
CLE-500 is being developed as a self-administrated intra-nasal drug-device combination product for the immediate relief of cluster headache attacks.
CLE-300 is a disruptive platform of wearable drugs.
CLE-600 is using Clexio’s 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.
It is a versatile platform, suitable for multiple APIs and enabling high drug loading.
It is targeting therapeutic drug levels for 8 – 24 hours, under fast and fed conditions.
Phase 1 studies were performed and demonstrated promising pharmacokinetic data.