08 Aug Delnova Announces First-In-Human Demonstration Of Reversal Of Neurotoxin Muscle Weakness
Neurotoxins, such as Botox®, Dysport®, Xeomin®, Jeauveau® and, most recently, Daxxify®, are used for wrinkle reduction in facial aesthetics. Despite botulinum neurotoxin efficacy in reducing wrinkle severity, several adverse effects may arise from spread of toxin beyond the target treatment area, and yet there is no reversal agent. In this proof-of-concept human study, we investigated the potential for ReViVox® as a candidate small molecule drug to reverse muscle paralysis or weakness. Results were positive in showing the reversal effect in a small cohort of healthy subjects.
SAN DIEGO, Aug. 8, 2023 /PRNewswire/ — DelNova Inc., is developing a rescue drug, ReViVox®, to resolve side effects that may result from botulinum neurotoxin treatment. Neurotoxins, such as Botox®, Dysport®, Xeomin®, Jeauveau® and, most recently, Daxxify®, are used for wrinkle reduction in facial aesthetics.
Although neurotoxins are effective in reducing wrinkle severity, several known adverse effects, such as ptosis (e.g. droopy eyes or low-lying brows), can arise from spread of neurotoxins beyond the target treatment area. Although these adverse events are transient, they can severely impact a patient’s quality of life, and there is currently no commercially available reversal agent for neurotoxins.
In a proof-of-concept study, volunteer subjects who experienced wrinkle reduction from the neurotoxin treatment were subjected to reversal therapy. Based on a 4-point validated photo-numeric scale, subjects treated with the ReViVox® active drug demonstrated recovery in muscle movement as soon as 5 minutes after treatment. This is the first human demonstration of the reversal of muscle weakness caused by a neurotoxin via a local muscle injection. These results further validate the potential for ReViVox® as a candidate drug for neurotoxin rescue.
This study was conducted by Steve Yoelin, M.D. (Newport Beach, CA), a board-certified ophthalmologist who is a leading practitioner, researcher, and trainer of neuromodulators, dermal fillers, and other medical aesthetic products in the United States. Dr. Yoelin delivered a compelling presentation at the 17th Annual Botulinum Research Symposium on July 21st. We are excited to be the first to demonstrate evidence of reversal in a clinically relevant patient setting. We congratulate Dr. Yoelin for bringing to bear his renowned expertise in the design and conduct of this study.
Botulinum neurotoxins represent over $5 billion in revenues worldwide for both aesthetic and medical therapies, yet there is no treatment to reverse potentially undesirable side effects. DelNova is poised to deliver on this unmet need with a transformative patent-protected drug candidate.
About DelNova, Inc.
DelNova, Inc. is a privately held biopharmaceutical company developing innovative therapeutics using clinically validated molecules linked to advances in drug delivery to solve unmet medical needs. The company’s lead clinical candidate, ReViVox®, is designed for the rescue of complications caused by off-target muscle paralysis following aesthetic and medical neurotoxin therapies, specifically botulinum toxins type A (e.g., Botox®).
Mary Gardner, Chief Executive Officer
About DelNova, Inc.
Solving Botulinum Treatment Complications