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It is being developed in different strength formulations for the treatment of fungal infections of the nail and skin, including onychomycosis and tinea pedis, with BB2603\u20101 (0.01% terbinafine) tested in the present trial. The aim of this study was to assess systemic exposure, safety and tolerability of BB2603\u20101 compared with Lamisil<jats:sup>\u00ae<\/jats:sup> AT 1% spray and BB2603\u20101 vehicle control in onychomycosis and tinea pedis. Preliminary mycological and clinical activity were also investigated. This was a single\u2010centre Phase\u00a01\/2, randomised, partially blinded, active\u2010 and vehicle\u2010controlled, parallel\u2010group trial in 46 subjects with onychomycosis associated with tinea pedis. Part 1 investigated BB2603\u20101 versus Lamisil AT 1% spray and BB2603\u20101 vehicle (4\u00a0weeks treatment). Part 2 investigated BB2603\u20101 versus BB2603\u20101 vehicle (additional 48\u00a0weeks treatment). No measurable systemic exposure of terbinafine was shown over 52\u00a0weeks of treatment with BB2603\u20101. BB2603\u20101 had an excellent safety and tolerability profile with no drug\u2010related safety findings and no evidence of skin sensitisation. BB2603\u20101 showed preliminary evidence of anti\u2010dermatophyte activity, demonstrated by a reduction in dermatophyte positive cultures and a reduction in microscopic evidence of dermatophytes. The pharmacokinetic, safety and efficacy data from this trial support further development of the topical terbinafine\u2010based nano\u2010formulation BB2603 in fungal infections of the skin and nail, including onychomycosis and tinea pedis.<\/jats:p>","DOI":"10.1111\/myc.13448","type":"journal-article","created":{"date-parts":[[2022,4,25]],"date-time":"2022-04-25T08:10:24Z","timestamp":1650874224000},"page":"661-669","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Results from a Phase 1\/2 trial of BB2603, a terbinafine\u2010based topical nano\u2010formulation, in onychomycosis and tinea pedis"],"prefix":"10.1111","volume":"65","author":[{"given":"Rainard","family":"Fuhr","sequence":"first","affiliation":[{"name":"Parexel International GmbH  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Cook","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Ridden","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerry","family":"Nield","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3445-9971","authenticated-orcid":false,"given":"Emma","family":"Leigh","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Cook","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Davies\u2010Strickleton","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juergen","family":"Dobmeyer","sequence":"additional","affiliation":[{"name":"Blueberry Therapeutics Limited  Macclesfield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,5,20]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Lamisil tablets 250\u00a0mg Summary of Product Characteristics September2020.https:\/\/www.medicines.org.uk\/emc\/medicine\/1290\/SPC\/Lamisil%20Tablets%20250mg#ORIGINAL"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00128071\u2010200304010\u201000005"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD012093.pub2"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/mmy\/myw084"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468\u20103083.2011.04373.x"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.18646.1"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.4103\/idoj.IDOJ_280_18"},{"key":"e_1_2_9_9_1","unstructured":"Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review. 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