A quick glance at the Ceragenix technology portfolio could likely result in the assumption that the company is developing two unrelated medical products. But CEO Steven Porter has a different understanding, seeing a connective theme behind the science of each product and similar types of business opportunities. Ceragenix possesses exclusive licenses to skin barrier repair technology (BRT) and to Ceragenin™ and CeraShield™ Antimicrobial Technology.
From a scientific perspective, these technologies both relate to the body’s natural defense system. The human skin serves as the body’s first defense against pathogens, a function it can only perform properly if it remains intact. Ceragenix’s BRT focuses on repairing the skin by providing three key lipids in the appropriate ratio that essentially serve as the mortar holding together the outermost layer of skin to keep pathogens out and prevent the body’s inflammatory and immune response. The company’s other technologies, Ceragenins and Cerashield, serve as “small molecule mimics to antimicrobial peptides” (AMPs) which are highly effective parts of the body’s innate immune response. Like naturally occurring AMPs, these Ceragenins kill bacteria through interacting with and disrupting the negatively charged cell membranes of bacteria. This process makes it extremely unlikely that bacteria can or will develop resistance, which is historically the case with traditional antibiotics that operate on specific pathways within cells. Where Ceragenins diverge from naturally occurring AMPs is both through increased potency and ease of synthesis relative to long-chain peptides. The lead Ceragenin, CSA-13, has shown broad activity against a wide variety of bacteria in testing, including 120 days of continuous antimicrobial effect against E. Coli on a silicon ring.
From a business perspective, first and foremost Porter looks to products that offer “several shots on goal.” He is not interested in the 10 years and one chance model provided in traditional drug development, instead gravitating to technologies with a variety of potential applications and relatively shorter regulatory paths. The other commercial factor Porter looks for are markets that recently experienced “tectonic events,” as such major disruptions generate opportunities for new entrants. Both the BRT and Cerashield are entering markets with just such conditions.
The BRT is currently used in EpiCeram®, a product launch in the US in October for the treatment of atopic dermatitis through a 510(k) approval by the FDA. In trials it was proven to work as well as mid-strength topical steroid applications, which generally serve as the first-line treatment. Like topical steroid applications, the second line systemic biologic immunosupressants focus on the immune response to skin problems – an approach that can lead to some serious complications which resulted in a blackbox warning for systemic drugs. Porter believes these warnings have created an opening in the market for patients – and especially the parents of the many young children afflicted – seeking an effective but safe option. Porter sees products using BRT as the answer to this concern because instead of altering the immune system, they rather “fix the skin.” Along with EpiCeram’s currently approved indications, the technology is being evaluated for use in babies as well as for licensing opportunities in markets outside the US. Potential also exists for testing and eventual use in other skin conditions that involve barrier disruption.
Ceragenins and Cerashield could be applied to any medical device where bacterial growth – and especially the growth of difficult to eradicate biofilms – is of major concern, which includes such significant markets as urinary catheters and ventilation tubes. The company has received notification that devices combined with Cerashield will be regulated as devices and not drugs, substantially reducing time to market if the technology proves successful. While Porter expects some may require the more extensive PMA regulatory process, other products may get approved with the more streamlined 510(k) procedure with a “robust toxicity package.” Porter is also confident that devices incorporating Cerashield could charge a substantial premium, as infection prevention is a core focus within hospitals – especially since the recent Medicare announcement that it would no longer reimburse for the costs associated with certain hospital acquired infections. Porter notes “Cerashield will work better in some applications than others – that’s inevitable.” But with negotiations ongoing with over 20 medical device manufacturers to incorporate the technology into existing devices, the company can succeed with a few misses. Ceragenix is also afforded more “shots on goal” with this partnering approach, as other companies take on many of the development costs.
While the potential for an array of products remains highly promising from a corporate perspective, Porter understands that the medicinal opportunity of Cerashield is the paramount benefit. Speaking of drug resistant bacteria, he confides, “We are one or two mutations away from the Dark Ages.” Yet if the promise of the technology bears out, this self-proclaimed “marketing and sales guy” and the company he leads might just keep the darkness from the dawn.
