terbinafine hydrochloride (BB2603) / Blueberry Therap - LARVOL DELTA

In Vitro Interaction of Tacrolimus (FK506) with Conventional and Nanoformulated Antifungal Drugs Against Clinical Dermatophyte Isolates Including Trichophyton indotineae. (PubMed, Assay Drug Dev Technol) - "Nanoposaconazole showed superior antifungal activity compared to posaconazole...Itraconazole proved to be the most effective antifungal. Combining tacrolimus with antifungal drugs, particularly nanoposaconazole, shows promise and warrants further investigation."

Journal • Preclinical • Dermatology • Infectious Disease

A Double-Blind Randomised Clinical Trial of Terbinafine-Nanostructured Lipid Carriers: Should We Anticipate This Strategy for Effective Topical Treatment of Onychomycosis? (PubMed, Mycoses) - "The application of TBF-NLCs gel 1% demonstrated a quicker clinical recovery without adverse side effects compared to TBF cream, thus highlighting the effective nature of NLCs."

Clinical • Journal • Infectious Disease

Results of a Phase 2 Randomized, Double-Blinded Trial of BB2603 Topical Treatment in Subjects with Distal Subungual Onychomycosis of the Toenail (EADV-Sp 2024) - No abstract available

Clinical • P2 data • Infectious Disease

A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail (clinicaltrials.gov) - P2 | N=111 | Completed | Sponsor: Blueberry Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Terbinafine Nanohybrid: Proposing a Hydrogel Carrying Nanoparticles for Topical Release. (PubMed, Pharmaceutics) - "Rheological properties were analyzed by temperature sweep tests at different addition orders of nanoparticles into hydrogel formation. The rheological behavior of nanohybrid hydrogels showed the influence of TBH-PCL nanoparticles addition in the mechanical properties of the hydrogel and a long-term release of the nanoparticles from it."

Journal

A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Blueberry Therapeutics | Recruiting ➔ Active, not recruiting | N=220 ➔ 132

Enrollment change • Enrollment closed • Infectious Disease

Results from Phase 1/2 trial of BB2603, a terbinafine-based topical nano-formulation, in onychomycosis and tinea pedis. (PubMed, Mycoses) - "The pharmacokinetic, safety, and efficacy data from this trial support further development of the topical terbinafine-based nano-formulation BB2603 in fungal infections of the skin and nail, including onychomycosis and tinea pedis."

Journal • P1/2 data • Dermatology • Infectious Disease

A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Blueberry Therapeutics | Trial completion date: Aug 2022 ➔ Jul 2023 | Trial primary completion date: Dec 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Infectious Disease

Effect of fluconazole and terbinafine nanoparticles on the treatment of dermatophytosis induced by Trichophyton mentagrophytes in guinea pig. (PubMed, Iran J Microbiol) - "On day 40, all groups had zero scores except the positive control group. This study indicated that nano-drugs are more suitable for the treatment of dermatophytosis and could be considered as future alternatives for the treatment of dermatophytosis."

Journal • Dermatology

A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail (clinicaltrials.gov) - P2; N=220; Recruiting; Sponsor: Blueberry Therapeutics; Suspended ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail (clinicaltrials.gov) - P2; N=220; Suspended; Sponsor: Blueberry Therapeutics; Trial completion date: Jul 2021 ➔ Aug 2022; Not yet recruiting ➔ Suspended; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Trial suspension • Infectious Disease

Newly added product (clinicaltrials.gov) - P2, Dermatology

Pipeline update