Clexio Biosciences

Clexio Biosciences is pleased to announce that we have reached 50% enrollment in our CLE-400 Phase 2 proof-of-concept study, in subjects suffering from chronic pruritus associated with Notalgia Paresthetica.   The study is a randomized, double-blind, vehicle-controlled multi-center study, enrolling in the US, assessing the efficacy and safety of our CLE-400 topical gel.   Notalgia Paresthetica is a type of sensory neuropathy associated with chronic itch in the upper back. Patients’ quality of life, sleep, and mood can be negatively impacted by this condition. To-date, there are no approved treatments for this condition.   CLE-400 is a topical formulation containing a potent α2-adrenergic agonist, a non-opioid and non-steroid. CLE-400 is an investigational drug and is currently not approved for commercial distribution. For more information on CLE-400: https://lnkd.in/dQ-GJkwE #clexio #clinicaltrials #notalgiaparesthetica #itch #dermatology #neuropathy

We are pleased to announce that Clexio has initiated enrollment in the SOLEO study, a Phase 2 study assessing the safety and efficacy of CLE-100 as an adjunctive treatment in subjects with Major Depressive Disorder. The study will enroll 90 subjects across the US. The first subject was randomized today. This new study follows the encouraging results from the CLEO proof of concept study, in which CLE-100 showed a good safety profile and, in the subgroup of subjects enrolled during the post-acute Covid period, promising efficacy. The CLEO study results were presented at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2023). https://lnkd.in/dGSeqvpn CLE-100 is an investigational, oral, NMDA receptor antagonist being studied as a potential treatment for Major Depressive Disorder with an inadequate response to previous treatment with antidepressants. For more information on CLE-100, please visit: https://lnkd.in/dr5VefZ2 For more information on the SOLEO study, please visit: https://lnkd.in/dA6EwaUk #Clexio #MDD #Depression #clinicaltrial

We are excited to have presented our CLE-100 phase 2 results at the prestigious 'Oxford on Ketamine and related compounds' Conference. #clexio #mentalhealth #ketamine #clinicaltrials

We are excited to update that Clexio has initiated a Phase 2 Proof of Concept study, to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adults with Notalgia Paresthetica. The study is a randomized, double-blind, vehicle controlled multicenter study enrolling in the US.   Notalgia Paresthetica is a type of sensory neuropathy responsible for chronic itch in the upper back. Many who suffer from this condition find it affects their days and nights, their everyday functions, and may impact their quality of life and well-being. To-date, there are no approved treatments for this condition. CLE-400 is a topical formulation containing a potent α2-adrenergic agonist molecule that is both a non-opioid and a non-steroid.   For more information on CLE-400: https://lnkd.in/dqsbbiEJ #nervepain #notalgiaparesthetica #clexio #clinicaltrials  

Some insights into Clexio’s approach to New Technology and Innovation, as shared in the recently published article in ONdrugDelivery which was written by our own Shai Assia in partnership with CDP. For the full article: https://lnkd.in/dXpKNg-d www.clexio.com #drugdelivery #drugdevelopment #clexio  

Clexio is looking for a top CMC Project Manager! Responsibilities:    -Overall responsibility for managing key activities across CMC disciplines, including formulation and analytical development, CMO selection and Tech transfer to CMO, clinical Trial material manufacturing and establishing CMC documentation for regulatory submissions. -Formulation design/development. -Write and reviewin documents for INDs / regulatory section submissions. -Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. -Establish and manage integrated CMC timelines for formulation development, analytical development, clinical trial material manufacturing and release of clinical batches.   Skills & Qualifications: -PhD in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutical Science, or related scientific discipline- a must. -At least 10 years’ relevant experience in development and manufacturing of oral dosage forms (e.g., tablets, capsules, etc.,) under pharmaceutical CMC/cGMP environment, for Phase 1 through Phase 3 clinical trials. -Extensive knowledge of the manufacturing process, related equipment for oral dosage form products. In-depth, hands-on experience in formulation development of oral solid and liquid pharmaceutical dosage forms. -Substantial experience in managing International CMOs for the manufacture of cGMP Drug Product. -Experience with cGMP manufacturing ; IND, IMPD, CTA and NDA filings; -Thorough knowledge of relevant FDA and EMEA regulations. -Excellent written and verbal communication skills in English. -Exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).   Please send CVs to: cjobs@clexio.com #clexio #hiringnow #pharmaceuticalindustry