Awakn Life Sciences Enters Into Global Licensing Agreement For Sublingual Delivery Formulation
Awakn Life Sciences (NEO: AWKN, OTCQB: AWKNF), a clinical-stage biotechnology company specializing in the development of ketamine-assisted treatments for addiction, has entered into a global licensing agreement with LTS Lohmann Therapie-Systeme AG. Headquartered in Andernach, Germany, LTS focuses on creating advanced therapeutic solutions, including transdermal and oral thin film drug delivery technologies in the biotechnology industry.
The agreement pertains to an exclusive proprietary S-ketamine formulation, administered sublingually via an oral thin film (OTF). This formulation, successfully evaluated in a Phase 1 clinical trial by LTS, holds global exclusivity for Awakn in its application to addiction, anxiety and eating disorders. LTS has also secured patents in key international markets, including the US, China, Canada, Europe, and Japan.
By securing access to the Phase 1 clinical trial data and obtaining exclusive global rights to the proprietary formulation for the specified indications, Awakn ensures robust intellectual property protection and expedites the potential progression to late-stage clinical trials. The sublingual S-ketamine formulation represents a significant advancement in addiction treatment, offering the potential for faster onset of action, precise dosing, and reduced adverse effects compared to traditional delivery methods.
The comprehensive licensing agreement encompasses terms related to milestone payments, royalties, and the commercial manufacturing of the drug product by LTS.
Sublingual & Transdermal Administration Offers Therapeutic Benefits
Sublingual administration is often faster than other forms of therapeutic administrations due to the unique physiological characteristics of the sublingual route. When a medication is administered sublingually, it is placed under the tongue, allowing for direct absorption into the bloodstream through the rich network of blood vessels located in the sublingual mucosa. The sublingual mucosa is thin and highly permeable, providing a rapid and efficient pathway for the drug to enter the systemic circulation.
By avoiding the digestive tract and liver, sublingual administration allows for a more direct and immediate absorption of the medication. This can result in a faster onset of therapeutic effects because the drug quickly enters the bloodstream, reaching systemic circulation without undergoing significant alteration or degradation.
Additionally, the sublingual route is associated with increased bioavailability, meaning a higher proportion of the administered drug ultimately reaches the bloodstream in its active form. The avoidance of first-pass metabolism and the rapid absorption contribute to the overall efficiency of sublingual administration, making it a preferred method for certain medications where rapid onset of action is critical for therapeutic success.
As well, transdermaladministration involves delivering therapeutic agents through the skin for systemic absorption into the bloodstream.
This method typically utilizes adhesive patches containing the medication, allowing it to permeate the skin and enter the circulation over an extended period. Transdermal delivery offers several benefits, including sustained and controlled release of the drug, leading to consistent therapeutic levels in the bloodstream.
Awakn Life Sciences Already Engaged In Late-Stage Ketamine Trial
In November 2023, Awakn attained regulatory and ethical clearance for the commencement of a phase III clinical trial. The Medicines and Healthcare products Regulatory Agency (MHRA) granted clinical trial authorization, while the Health Research Authority in the UK provided ethical approval for Awakn’s flagship program, AWKN-P001. This phase III trial aims to evaluate the efficacy of the treatment for Severe Alcohol Use Disorder (SAUD).
AWKN-P001 is a novel combined therapeutic of a N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho-social support to treat SAUD.
Currently, there are no indications on whether Awakn has compound AWKN-P001 in mind in regards to future delivery mechanism alterations.
