DelNova
Advanced Therapeutics for Botulinum Toxin Complications

Botulinum toxin type A is widely used in non-surgical cosmetic procedures and medical therapies. This drug remains highly controversial owing to several undefined adverse side effects. With more than two decades of experience in the life sciences and pharmaceutical industry, Mary Gardner was alerted to the complications created by botulinum. She wanted to change the status quo through innovative therapeutics. This goal materialized in 2016 when Mary laid the foundation of DelNova. It is the only company in the industry that is developing a feasible solution, ReViVox™, to address botulinum toxin type A complications following aesthetic and medical neurotoxin therapies.

Neutralizing the Botulinum toxin type A Drawbacks

“Botulinum neurotoxin blocks muscle function, leading to muscular paralysis,” says Mary, who is currently donning the role of CEO and Founder at DelNova. In fact, the FDA requires black box labeling on botulinum toxin type A and similar products to warn about the rare but potentially life-threatening complications when the toxin’s effects spread systemically beyond the injection site.

When it comes to cosmetic/ aesthetics treatments, botulinum toxin type A can cause ptosis (droopy eye) or a droopy brow. It can also create facial misalignment if the injection is administered without proper understanding of muscle structure. On the medical side, the drug is used totreat overactive bladder. This may result in serious side effects, including urinary retention and infection, and may require catheterization. Botulinum toxin type A has also been used to provide relief for migraines but has in some cases triggered the problem of weak neck muscles. As a result, patients may be impelled to wear uncomfortable neck braces.

Most of the patents filed to address side-effects of botulinum toxin type A have been for antitoxins. These antitoxins need to be administered almost immediately after the drug is administered to patients. They fail to serve the problem of adverse effects of the toxin as it is too soon to identify the side effects.

Even though these side-effects are temporary and fade away after a few weeks or months, they cause immense distress and discomfort to patients.

Unlike others in the industry who have tried to resolve this issue by focusing on the toxin, DelNova addresses these complications ‘outside of the neuron.’ Its novel solution, ReViVox, acts as the perfect rescue product for all these complications without changing the toxin.

ReViVox: Reversing Botulinum toxin type A Complications

DelNova is formulating ReViVox, based on a clinicallyvalidated molecule used for reversing residual paralysis following an anesthesia procedure. However, the company has radically transformed the use of this molecule to enable physicians to administer this drug locally rather than systemically. ReViVox is expected to be a safe, low-dose formulation of an anticholinesterase which is under development to remedy off-target muscle paralysis owing to botulinum toxin type A.

ReViVox is currently being developed as an injectable formulation that experts can administer in a targeted area. The company is also looking at the potential for transdermal or topical formulation in the future.

DelNova is currently in the preclinical stage and is working toward collecting clinical data to validate the initial success of ReViVox. The company has already conducted a preliminary nonclinical proof of concept, collaborating with CRO partners to generate positive proof-of-concept data. DelNova’s team has demonstrated the successful reversal of muscle weakness in animal muscle using ReViVox. The company is planning for a Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA to confirm a 505b2 regulatory pathway. If confirmed, DelNova anticipates conducting a combined phase 1/phase 2 study followed by a phase 3 pivotal study. Based on preclinical data, DelNova’s patent has already been issued in the U.S. The company’s primary goal is to establish itself in the medical aesthetics market, which represents 40 percent of the $5 billion botulinum neurotoxins market.

Moving ahead, DelNova will continue to actively pursue additional equity investment, which will be critical to propel the company forward in its endeavors. Once human data is available, it will become an attractive target for potential partners in the marketplace. DelNova’s core strategy is to partner with one of the leading botulinum neurotoxin manufacturers to further its studies. “There is no biosimilar for botulinum neurotoxins. It is therefore important to study each independent neurotoxin to determine the dosage of our product. With our robust solutions, we offer comfort and assurance to both patients and practitioners,” concludes Mary.