By GREGORY ZELLER //
The National Institutes of Health is backing an early-stage Kings Park biotech’s quest for non-antibiotic-based COVID-19 treatments.
CMTx Biotech has non-antimicrobials in its sights and a who’s-who of industry veterans at the helm, and now a $315,000 Clinical Trial Planning Grant from the NIH’s National Center for Advancing Translational Sciences fueling its engines.
Lorne Golub: Confident co-founder.
Launched in 2019, the company – which “pivoted to COVID” in 2020, according to Co-founder Joseph Scaduto – will use the grant to finalize a Phase II human clinical study of incyclinide, its leading drug candidate for the treatment of hospitalized COVID-19 patients. The clinical trial will also help CMTx Biotech grease the skids with the U.S. Food and Drug Administration and other regulators, with more advanced studies in mind.
It also marks a big step for the use of non-antimicrobial tetracycline formulations as a novel coronavirus treatment – but non-antimicrobial tetracycline formulations, of course, are a particular specialty of CMTx Biotech Co-Founder Lorne Golub.
And CMTx has got the goods, according to Golub.
“Incyclinide has already been shown to be highly effective in a number of animal models of acute respiratory distress syndrome across several species,” noted the SUNY Distinguished Professor of Oral Biology and Pathology, who teaches at the Stony Brook University School of Dental Medicine and says the novel compound resolves inflammation “primarily responsible for lung-tissue damage.”
“We are very confident that this promising drug candidate will benefit COVID-19 patients,” added Golub, who previously scored NIH backing for – and ultimately commercialized – non-antibiotic pharmaceuticals Periostat (for the treatment of periodontal disease) and Oracea (for the treatment of rosacea). “We look forward to the opportunity to demonstrate this in the clinic.”
Joseph Scaduto: Innovative intervention.
“We” includes fellow co-founders Scaduto – who previously partnered with Golub on Stony Brook-based biotech Traverse Biosciences, which also takes unique pharmaceutical shots at inflammation – and James Keane, the CMTx Biotech chief operations officer (along with co-founder and “Charcot-Marie-Tooth Disease Patient Advocate” Sonny Granger, a Florida-based commercial real estate advisor).
Also in the fold are Vice President of Scientific Affairs Christopher Czura – a former Feinstein Institutes for Medical Research VP with a long history of med-tech innovation and a dance card packed with board assignments and advisory roles – and Vice President of Chemistry, Manufacturing and Controls JoAnn Wilson, a California-based chemist with a PhD from Wayne State University and a track record of corporate excellence.
Czura and Wilson top an impressive list of clinical researchers and business-development professionals, all of whom joined CMTx Biotech for the wide promise of small-molecule non-antimicrobial drug candidates – incyclinide has been shown to normalize a variety of cellular and molecular “host inflammatory mediators,” according to the startup – and were all-in when the company pivoted hard toward COVID, noted Scaduto, the CMTx’s CEO.
Now, even with vaccines slowly making the rounds, the novel coronavirus is still making people sick – and “there remains a critical unmet medical need for safe and effective interventions for the treatment of COVID-19 patients,” according to Scaduto, who believes incyclinide fits the bill.
“This NCATS award will help accelerate our effort to … evaluate its ability to reduce hospital stay, prevent acute lung injury and improve survival of hospitalized COVID-19 patients,” the CEO added.
