Alar Pharmaceuticals’ long-acting, ketamine-based therapy has shown early signs of symptom improvement in treatment-resistant depression (TRD) in a Phase I study.
In the trial (NCT06965569), ALA-3000, a sustained-release ketamine injection, met its primary endpoint, demonstrating a favourable safety and tolerability profile.
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In exploratory efficacy endpoints, ALA-3000 in combination with an oral antidepressant demonstrated rapid and sustained antidepressant effects, as assessed by the Montgomery–Åsberg Depression Rating Scale (MADRS).
MADRS total scores decreased as early as 24 hours post-dose. Improvements were sustained from day nine to day 36, where ALA-3000 demonstrated ~3 to 6 points (150mg) and ~2 to 4 points (250mg) greater reduction compared to placebo.
Response rates reached ≥60% in the 150mg cohort and up to 69% in the 250mg cohort compared with 36% to 45% for placebo-treated patients, between day 11 and day 36.
Alar noted that ALA-3000 may offer meaningful clinical advantages, including durable antidepressant effects with reduced burden of frequent dosing and clinical visits. By avoiding rapid peak plasma levels associated with acute ketamine treatment, ALA-3000 mitigates adverse events (AEs) such as dissociation and sedation. As a result, this could eliminate the need for mandatory prolonged post-dose on-site monitoring required by current ketamine therapies.
In the study, patients received two SC injections of ALA-3000 (150mg or 250mg) or placebo administered one week apart, alongside a daily oral antidepressant. Treatment-related AEs were mild to moderate in severity, with no subjects discontinuing or withdrawing from the study due to AEs or any other reasons.
Charles Lin, founder and chairman of Alar Pharmaceuticals, said: “While ketamine has shown robust clinical efficacy in TRD and holds promise in other indications such as post-traumatic stress disorder, fibromyalgia, and Parkinson’s disease, its clinical utility has been constrained by pharmacokinetic limitations and psychiatric safety concerns. ALA-3000 is designed to overcome these barriers, enabling broader adoption and maximising its therapeutic and commercial value.”
The most notable ketamine-based product approved in TRD is Johnson & Johnson’s Spravato (esketamine), which gained US Food and Drug Administration (FDA) approval in March 2019. When administered, patients must be monitored for at least two hours by a healthcare provider in case of AEs, creating a burden on healthcare settings that Alar is hoping to reduce or eliminate.
GlobalData anticipates that across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan and Canada), the major depressive disorder (MDD) market will grow to be worth approximately $9.55bn by 2029, compared with $4.73bn in 2019.
This will be buoyed by the potential launch of six new pipeline products throughout the 8MM, which will have significantly higher costs of therapy when compared to commonly used MDD treatments that have high generic availability. GlobalData is the parent company of Clinical Trials Arena.
