- Eliem Therapeutics Inc (NASDAQ:ELYM) announced interim results from its ongoing Phase 1 trial of ETX-155 for major depressive disorder (MDD) and epilepsy.
- Following lower-than-expected drug exposure levels in the three subjects in a Phase 1b photosensitive epilepsy (PSE) trial, Eliem initiated a Phase 1 trial in healthy subjects to confirm the pharmacokinetic profile of ETX-155.
- ETX-155 demonstrates exposures in single dose 60-milligram cohorts of ongoing Phase 1 pharmacokinetic trial consistent with prior trials.
- Also see: Eliem Therapeutics Shares Fall On Lower Back Pain Trial Setback.
- Eliem plans to evaluate a 75-milligram dose of ETX-155 in the repeat dose part of the ongoing Phase 1 pharmacokinetic trial in healthy subjects.
- Final results, including the repeat dose cohort, are expected in Q4 of 2022.
- The company plans to start the Phase 2a MDD trial in Q1 of 2023, with the topline data expected in mid-2024.
- The company also said it will not reinitiate the PSE proof-of-concept trial but will continue to pursue the development of ETX-155 in focal onset seizures.
- The company is progressing two preclinical candidates from the Kv7.2/3 channel opener program for IND-enabling safety studies, expected in Q1 of 2023, with Phase 1 studies expected to start in 1H of 2024.
- The company has discontinued the preclinical development of a non-sedating anxiolytic for generalized anxiety disorder because none of the compounds achieved the required profile.
- The company ended the September quarter with a cash balance of $129.8 million, expected to fund operations into 2025.
- Price Action: ELYM shares are trading lower by 1.97% at $2.98 on the last check Wednesday.
CBD-Focused Avicanna Taps Into European Market Via Exclusive Pharma Supply Deal
Canadian cannabinoid-based biopharmaceutical firm Avicanna will supply two proprietary topical products to an unnamed multinational pharmaceutical firm in six European countries in 2024. The deal will commercialise Avicanna's RHO Phyto brand in Europe for the first time. The company praised its own proprietary patent-protected technologies being entered into "the European market without competition" as testament to its "scientific and technical leadership in the cannabinoid clinical and commercialisation field", highlighting the deal's strategic nature and geographic position, as well as the expected rapid expansion into other European countries. The unnamed pharmaceutical company manufactures and markets a wide range of pharmaceuticals across four continents and has established a commercial infrastructure in Europe. These manufacturing plants will produce Avicanna's Ultra-CBD cream and CBG Transdermal Gel in 2024.
