Terbinafine

Hallux Announces Poster Exhibit Abstract ID 74740 on Dermatophytoma Treatment by HSG 42 in Phase 2a trial Available for Viewing at the 2026 AAD Annual Meeting HSG-42 is uniquely administered by physicians at the point of care. This novel treatment for toenail onychomycosis includes moderate-to-severe conditions and those plagued by dermatophytoma.” — Mark Taylor CEO LAGUNA HILLS, CA, UNITED STATES, March 27, 2026 / EINPresswire.com / -- Hallux Inc. a clinical-stage pharmaceutical company focused on nail disease today announced that treatment data and toe images associated with resolution of dermatophytoma by investigational drug HSG-42 in a 56-year old active adult is available for viewing at the 2026 American Academy of Dermatology Annual Meeting being held in Denver, Colorado on March 27 – 31, 2026. Details of the Hallux Inc. Poster Exhibit Abstract (ID 74740) Title: Terbinafine Subungual Gel (HSG-42) investigated for toenail onychomycosis, including refractory dermatophytoma: a case study from a Phase 2a open-label trial Category: Infection – Fungal Authors: Tracey Vlahovic DPM FFPM RCPS (Glasg) Podiatric Physician, Member of Faculty of Podiatric Medicine of the Royal College of Physicians and Surgeons (Glascow), Terry Jones MD, Lewis Freed DPM, Mahmoud Ghannoum PhD, and Phoebe Rich MD The full abstract content is available at the AAD viewing stations and website . We have long believed that HSG-42 may be highly effective against toenail onychomycosis, including conditions compromised by dermatophytoma, because of its direct application onto the mycotic nail bed by clinicians at the point-of-care. Dermatophytoma is difficult to eradicate with conventional oral and topicals and therefore excluded from pivotal trials. In HSG-201, investigators treated 10 cases of dermatophytoma and were generally encouraged by the efficacy demonstrated, both visually and mycologically. This abstract highlights one such case. Our upcoming Phase 2b study, HSG-202, will stratify dermatophytoma patients for evaluation against a vehicle-control. About Hallux Inc. Hallux is a clinical stage pharmaceutical company determined to bring to market a novel subungual-topical form of terbinafine to treat toenail onychomycosis that is uniquely administered by physicians at the point of care, including moderate-to-severe conditions and those plagued by dermatophytoma. The Company recently completed a rigorous Phase 2a efficacy, safety, tolerability, and PK trial in 47 patients and is now preparing a Phase 2b vehicle-controlled study that in January 2026 received a study-may-proceed letter form the FDA. Mark Taylor Hallux Inc. +1 949-637-4656 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

A New Approach Enabling Physicians to Treat Toenail Fungus at the Point-of-Care HSG 42 is highly differentiated. It is the first subungual-topical treatment for toenail fungus administered by physicians in-clinic.” — Mark Taylor LAGUNA HILLS, CA, UNITED STATES, January 14, 2026 / EINPresswire.com / -- Hallux Inc. , a clinical stage pharmaceutical company focused on nail disease and common disorders of the lower extremities, today announced that it has received FDA approval to proceed with a Phase 2b clinical trial investigating lead product Hallux Subungual Gel 42% (HSG 42) in the topical treatment of toenail onychomycosis, including conditions compromised by dermatophytoma. The 56 week, vehicle controlled study evaluates the efficacy, safety and tolerability of HSG 42 administered in once monthly single doses directly onto the mycotic nail bed over 48 weeks. The primary efficacy endpoint is complete cure. Secondary endpoints include mycological cure and clinical cure. The 134 subject study, to be conducted in 12 clinical sites, will stratify subjects presenting with dermatophytoma, a common yet underdiagnosed subtype of onychomycosis characterized by fungal masses encapsulated in biofilm. Hallux CEO Mark Taylor said, “My deep appreciation goes to the small and dedicated Hallux team that ran the rigorous 47 subject, multicenter phase 2a pilot that was followed by a productive Type B meeting with the agency and the filing of this new IND enabling HSG 42 to proceed into its first well controlled study." HSG 42 is highly differentiated. It is the first subungual-topical treatment for toenail fungus administered by physicians in-clinic. It is the first antifungal agent to be evaluated against dermatophytoma in a controlled study. Pending statistically significant clinical outcomes, it could be the first terbinafine topical approved by the FDA for onychomycosis. About Hallux Inc. Hallux is a clinical stage pharmaceutical company determined to bring to market a novel subungual-topical form of terbinafine that is applied by physicians to treat nail fungus at the point-of-care. Hallux’s goal is to provide chronic sufferers of onychomycosis with a highly effective topical therapy that is quick, safe and administered by physician that kills fungi and reliably facilitates the regrowth of disease-free nail. Mark Taylor Hallux Inc. +1 949-637-4656 Mark@Halluxinc.com Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.