B2iDigital
Sep 29, 9:04 PM
Lakewood-Amedex Biotherapeutics Inc. (Nasdaq:
$LABT ) Chief Executive Officer Kelvin Cooper, Ph.D., sat down with Proactive after the company dosed the first patient in its Phase 2a trial of Nu-3, a topical antimicrobial gel for mildly infected diabetic foot ulcers, and explained why that indication came first.
Lakewood-Amedex Biotherapeutics Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/lakewood-amedex-biotherapeutics-inc-1
Cooper described an approach that runs against the usual course of oral antibiotics, in his words "a different approach than many antibiotic approaches, which typically go through an oral, a tablet that you take for a whole course of treatment":
• The company's compounds target antimicrobial-resistant bacteria, and, as Cooper put it, "we treat a disease where it occurs, the infection where it occurs": skin on the skin, lung in the lung, bladder in the bladder
• Infected diabetic foot ulcers came first because a regulatory filing requires a single indication, and, in Cooper's words, "it's a very serious disease, not well treated"
• The Phase 2a study is multicenter, single-blinded and dose-finding, evaluating Nu-3 gel at 2%, 5% and 10%, with topline data expected in the first quarter of 2027
On the trial's purpose, Cooper said: "And what we are aiming to do with our clinical trial is to go into a patient that's just discovered they've got an infection and sort of cap it right there. So we've got a topical drug. You apply it directly to the wound. It's a gel, and it will kill the bacteria in the wound."
Watch the full segment: https://www.proactiveinvestors.com/companies/news/1099239/lakewood-amedex-doses-first-patient-in-phase-2a-trial-for-diabetic-foot-infections.html
On what the trial is meant to establish, Cooper noted, "We call this trial a proof of concept trial. In clinical terminology, you don't know you've got something until you prove it in human beings, and that's our proof." He was explicit that any broader use depends on the result: "If it works, then yes, if we can apply the drug into the lung, we should be able to treat lung infections. Into the bladder, we should be able to treat bladder infections."
Lakewood-Amedex Biotherapeutics Inc. (Nasdaq: LABT) is a clinical-stage biotechnology Company developing a novel class of fast-acting, broad-spectrum antimicrobials, the Bisphosphocin® class, to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit https://lakewoodamedex.com.
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