With franchises in dermatology, wound care and oral health, closely-held Klox Technologies has three near-term milestones this year: launching its oral care business with Colgate Palmolive; expanding the Dermatology franchise; and seeking a marketing partner for its wound care business.
“We are the only fluorescence-based, topical technology on the market for skin and soft tissue disorders,” Trevor Arsenault, VP of business development and alliance management, says in an interview with BioTuesdays. “The technology has been validated in that two of our three programs are fully partnered.”
Mr. Arsenault explains that Klox’s BioPhotonics platform consists of a multi-LED lamp and a topical photo converter media, such as a gel, which includes light-capturing molecules. Once the gel is illuminated, different molecules in the gel produce different wavelengths of light, which penetrate the skin to different depths, he points out.
“This fluorescence biomodulation can stimulate cellular responses along with controlling bacteria, modulating inflammatory mediators, stimulating fibroblasts for collagen synthesis/deposition, modulating vascular endothelial growth factors, and myofibroblast formation,” he contends.
“And these hyper-pulsed fluorescence systems are modulated to individual indications,” he says, adding that current clinical programs have shown a high degree of safety and efficacy. “A point of differentiation is that this treatment is non-systemic.”
Klox was founded in 2007 by Dr. Francesco Bellini, a biotech entrepreneur and co-founder of BioChem Pharma, which discovered the antiviral, 3TC, a cornerstone for HIV/AIDS therapy.
The BioPhotonics platform, which can be used in combination with existing therapies or on its own, has CE Mark designations in Europe for dermatology, oral health and acute chronic wounds. In Canada, Klox has approval to use its technology in dermatology for the treatment of moderate-to-severe acne.
Mr. Arsenault says the Klox and LEO Pharma of Denmark have been collaborating since 2014 to develop Klox’s dermatology business and in March of this year, the business was spun out into a new company, FB Dermatology, which is jointly owned by both companies.
FB Dermatology is commercializing Klox’s BioPhotonic technology in dermatology under the brand name, Kleresca for acne and Kleresca for skin rejuvenation.
“Down the road, we are looking to expand in other dermatology indications, such as eczema and rosacea,” he adds. FB Dermatology is currently operating in seven countries in Europe and Australia, with plans to be in 12 countries by the first half of 2018.
In oral health, which is partnered with Colgate Palmolive, Mr. Arsenault says Klox has completed a proof-of-concept study, which showed statistical significance on clinical attachment after one treatment of its PERIO-1 gel as an adjunct to scaling and root planning in periodontal patients.
Periodontitis is the number one cause of tooth loss in adults and represents a $14-billion market.
In addition, he says Klox is focusing its business development activities to partner its wound care business, which has CE Mark approval for chronic and post-surgical wounds as well as burns in Europe.
In May, Klox reported positive results of a 100-patient EUREKA study as the European Wound Management Association in Amsterdam, with its LumiHeal gel for the treatment of hard-to-heal, non-responsive, chronic wounds.
The data confirmed an interim analysis reported in September 2016 on 33 patients with Venus leg ulcers (VLUs), diabetic food ulcers (DFUs) and pressure ulcers.
Among other things, the EUREKA study demonstrated a high rate of wound closure with LumiHeal, pain reduction, improved quality of life, control of bacteria and reduction of inflammation.
In addition, 96% of wounds that closed completely, remained closed throughout the follow up period, and 69.2% of VLUs and 68.8% of DFUs were ready for skin graft, according to the clinician’s opinion. A study with patients suffering from pressure ulcers is ongoing.
Mr. Arsenault says that the final results of the EUREKA study show, that taken together with efficacy, treatment ease of use, safety, and a positive impact on pain reduction, “LumiHeal has the ability to become a leading option for the treatment and management of hard-to-heal, chronic wounds.”
Klox also has an ongoing study in post-surgical scarring with 42 patients undergoing bilateral breast reductions, with full data set to be reported in the current quarter. Interim data demonstrated lower rates of hyper pigmentation and rates of red scars and normal scar height, compared with silicone sheets.
Regarding its R&D pipeline, Mr. Arsenault says the company is working in animal health, including indications, such as pyoderma and wound care, and has established strong preliminary data; burns; additional consumer products; and rare keratin and collagen-based genetic diseases, which is at the preclinical stage.
“Our positioning is the R&D of the BioPhotonics technology, then using partnerships to go to the market,” he points out. “We will continue to push and expand where the platform can be used.”