25 April 2017
Blueberry Therapeutics commence Phase I-II clinical trial of lead product BB2603
Blueberry Therapeutics are pleased to announce they have dosed the first patient in a Phase I/II clinical trial of BB2603 in fungal infection of the skin and nail following successful regulatory and ethics approvals. The trial, which is a safety and efficacy study in onychomycosis (fungal nail infection) and associated tinea pedis (athlete’s foot), began on March 28th 2017, with primary and secondary endpoints expected to read out during the second half of this year.
BB2603 is an innovative new treatment concept using nanotechnology to deliver terbinafine, a potent antifungal, through the nail and into skin to treat fungal infection. This novel patented nanomedicine will initially be used to treat onychomycosis which is a highly infectious disease with a high medical need that is currently poorly managed by current treatments.
Dr Mike Davies, Chief Medical Officer and co-founder of Blueberry Therapeutics, said, “This is a great achievement by the team at Blueberry that has led to approvals and the start of our first clinical trial with BB2603 – our exciting, novel nanoformulation of terbinafine to treat onychomycosis and associated tinea pedis”
Progression of the lead product into the clinic has been a major step forward for Blueberry in the development of its lead topical anti-fungal. The resultant data will be used to support the opening of an Investigational New Drug Application later this year in the United States.
John Ridden, CEO of Blueberry Therapeutics said, ‘This is an exciting time for Blueberry – we are making excellent headway in the development of BB2603 to establish its effectiveness in treating onychomycosis and associated tinea pedis. These are highly infectious fungal diseases which affect a large number of patients. Current treatments can take up to 18 months, have poor efficacy or cause unpleasant side effects. We hope that BB2603 will provide a safe and very effective alternative.’
Blueberry will be seeking to raise a further £30m in 2018 to run phase III clinical development planned to take place in 2019.
Andrew Kay Chairman of Blueberry commented, ‘There remains high medical need for an effective drug to topically treat fungal nail infection, and we look forward to fundraising following the current clinical trial to enable Blueberry to enter phase III development for this major blockbuster market.’