- HC Wainwright Matthew Caufield initiated coverage on Eyenovia Inc , focused on developing ophthalmic therapeutics based on the company’s microdose array print (MAP) platform and the Optejet spray device for optimizing topical corneal drug delivery.
- The analyst initiated coverage with a Buy rating and a $12 price target.
- The analyst notes that Optejet spray provides high precision micro-dosing and has been characterized to have greater than an 85% success rate for ocular topical delivery compared to the 40-50% for traditional eyedroppers, along with instantaneous corneal surface coating that surpasses the ocular blink reflex.
- Furthermore, Optejet’s volumetric control delivers approximately 8uL, comparable to the noted physiologic capacity of the tear film. In contrast, standard eye drops deliver upwards of 30-50uL, coinciding with prospective overdosing.
- HC Wainwright notes that the ophthalmic spray pipeline comprises:
- MicroLine pilocarpine for presbyopia, or age-related farsightedness, commonly treated with reading glasses.
- MydCombi fixed combination tropicamide 1% and phenylephrine 2.5% for pharmacologic mydriasis or induced eye dilation for comprehensive eye exams and cataract surgery.
- MicroPine atropine for the reduction of pediatric myopia progression, or nearsightedness, in children ages 3 to 12 years old.
- Eliem Therapeutics Inc 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.
- 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.
- Acer Therapeutics Inc expanded ACER-801 (osanetant) into a new indication for the reduction of the frequency and severity of acute stress disorder and post-traumatic stress disorder (PTSD).
- The company says up to 20% of people who have experienced a traumatic event will develop PTSD leading to over 12 million adults in the U.S. who have PTSD during a given year.
- Studies conducted at Emory University screened thousands of genes activated in mice's brains following fear conditioning events.
- The top gene identified was Tac2, responsible for producing the peptide Neurokinin B (NKB) in mice. The researchers showed that the Tac2 gene, expressed by neurons specifically within the amygdala, is required for modulating fear memories. NKB, and its specific receptor, NK3R, are also involved in consolidating fear memories.
- By administering the potent and specific NK3R antagonist, osanetant, they could block fear memory consolidation shortly after exposure to trauma.
- Acer licensed exclusive worldwide rights from Emory University to patents and patent applications for certain methods of treating or preventing PTSD with osanetant.
