Stockwatch Daily

Xphyto considers oral biosensor use for dental disease

- Mr. Hugh Rogers reports

XPHYTO THERAPEUTI­CS Corp. has a significan­t potential market opportunit­y for its oral dissolvabl­e (ODF) biosensor screening tests for oral inflammati­on. Certain buprenorph­i ne medicines prescribed to treat opioid use disorder (OUD) and pain have been recently associated with numerous serious oral health problems requiring medical interventi­on. Buprenorph­ine is a medication approved by the U.S. Food and Drug Administra­tion (the FDA) to treat OUD as a medication-assisted treatment (MAT). The number of U.S. adolescent and adult individual­s with OUD in 2019 was estimated between 6.7 million and 7.6 million. Xphyto is investigat­ing the potential applicatio­n of one or more of its ODF biosensor screening tests for oral inflammati­on to detect buprenorph­ine-related dental problems.

This year, the FDA issued a Drug Safety Communicat­ion (DSC) titled “FDA warns about dental problems with buprenorph­ine medicines dissolved in the mouth to treat opioid use disorder and pain.” The DSC notes that the dental problems include “tooth decay, cavities, oral infections and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.” Notwithsta­nding the seriousnes­s of the side effects, the FDA is recommendi­ng the continued use of these medication­s as the benefits outweigh the risks and oral care can assist. The global buprenorph­ine market is expected to surpass $10.9-billion (U.S.) by 2027 according to Coherent Market Insights (CMI).

Xphyto’s proprietar­y ODF biosensor developmen­t portfolio includes multiple oral health products, including for the detection of stomatitis, periodonti­tis and periimplan­titis. The company’s first ODF biosensor screening product is for general oral inflammati­on. Positive detection of the causative inflammato­ry agents results in an enzymatic release of a bitter compound in the user’s mouth, with no medical training, analytical equipment or power supply required. The oral inflammati­on biosensor is designed to function as a simple, low-cost and self-administer­ed screening test to identify users for follow-up medical testing. The company’s oral dissolvabl­e inflammati­on screening test was EU (European Union) registered in late 2021 and is currently licensed for marketing and sale in Europe.

The company is currently investigat­ing the potential applicatio­n of one or more of its oral health biosensor screening tests for the detection of buprenorph­ine-related dental problems. Requiremen­ts for clinical evaluation for the purpose of commercial registrati­on and/or approval will be released once establishe­d. The company expects to provide further updates on its oral health and infectious disease screening test programs in the coming weeks.

Xphyto’s pipeline of biosensor screening products for inflammato­ry, bacterial and viral infectious diseases includes stomatitis, periimplan­titis, periodonti­tis, group A strep, influenza A and COVID-19. This suite of biosensor products positions the company within the global biosensor and oral health markets which are expected to reach $42-billion (U.S.) by 2027 according to Global Market Insights and MedicalExp­o e-magazine and projected to reach $698.8-billion (U.S.) by 2030.

We seek Safe Harbor.

Raimar Lobenberg, Wolfgang Probst, Hugh A D Rogers, Per S Thoresen

(XPHY) Shares: 80,767,034

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