Hallux Starts Phase 2 Clinical Study Of Novel Subungual Gel For Onychomycosis

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Hallux Inc., a clinical stage pharmaceutical company, today announced that patient screening has begun for a phase 2 clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of Hallux Subungual Gel (HSG) in patients with distal-lateral subungual onychomycosis, a common fungal infection of the toenail bed.

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We are pleased to have leading foot and ankle surgeon Lewis H. Freed D.P.M. back as Principal Investigator. Podiatric physicians have a unique skill set that we want to benefit from as we optimize the safety and efficacy of this subungual approach. ~Mark Taylor, Hallux Inc. CEO

Hallux Inc., a clinical stage pharmaceutical company, today announced that patient screening has begun for a phase 2 clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of Hallux Subungual Gel (HSG) in patients with distal-lateral subungual onychomycosis, a common fungal infection of the toenail bed.

Thirty-five patients will be treated with HSG and followed for 52 weeks. The primary objective is to establish the efficacy and safety of once monthly and once bi-monthly topical doses of HSG administered directly to infection sites on the nail bed and subungual area.

Hallux has been focused for some time on the development of an effective terbinafine dosage form that when administered subungually results in high efficacy with minimal local or systemic side effects. HSG is designed for topical subungual administration to mycotic nails, said Mark Taylor, Hallux Chief Executive Officer. Our first product candidate was a micro implant that validated the subungual pathway but fell a bit short on overall efficacy at 48 weeks due in part to its limited treatment duration. We believe HSG is a better antifungal formulation for subungual performance, and it can be dosed longer. We’ve spent several years in development and are excited to return to the clinic to evaluate this product. We are also pleased to have leading foot and ankle surgeon Lewis H. Freed D.P.M. back as Principal Investigator. Podiatric physicians have a unique skill set that we want to benefit from as we optimize the safety and efficacy of this subungual approach.

Physicians Research Group of Tempe Arizona is the site management organization for the study. Interested parties may contact CEO Robert Wallace for more information. Further details on the trial can be found at clinicaltrials.gov.

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Mark Taylor, CEO
Hallux Inc
+1 (949) 637-4656
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Robert Wallace, BS, CCRC CEO
@Hallux_Inc
since: 09/2021
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