Blueberry Therapeutics has received an investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to proceed with the clinical development of BB2603 for the treatment of onychomycosis.

The IND is a crucial milestone in the continued development of BB2603, a nanoformulated, topical form of terbinafine for the treatment of onychomycosis (fungal toenail). With the IND in place the company has initiated a Phase IIb international, multicentre double-blinded study.

The primary outcome of this study is to look at the efficacy BB2603 in onychomycosis, with a secondary dose finding outcome also being investigated.

John Ridden, CEO said: “Having received clearance from the FDA we are looking forward to the opportunity to work with over 20 international sites on the Phase IIb trial of BB2603 with the first patient expected to be recruited in March 2020.This is a key milestone in our path to commercialisation of our nanotechnology product portfolio.”

With BB2603, Blueberry Therapeutics aim to maintain the efficacy of the oral gold standard treatment, but at a lower dose. Delivering the active pharmaceutical ingredient using nanotechnology ensures it penetrates across the nail plate and reaches the target site of action in a controlled manner, meaning lower doses can be used and systemic side effects are minimised.

Blueberry Therapeutics are delighted to welcome Emma Leigh as Medical Writing Lead, responsible for oversight of medical writing across nonclinical, clinical and regulatory deliverables. Prior to joining Blueberry, Emma has 18 years’ experience as a regulatory/medical writer within pharmaceutical companies (AZ and GSK), medical communications agencies, and in a freelance capacity. Emma has a PhD in Medical Genetics and a BSc (hons) in Biochemistry and Genetics. Outside of work, Emma enjoys camping and walking with her family in the Peak District.

Emma Leigh

Blueberry CEO John Ridden has been invited to speak at BioCap this October at Alderley Park. John is pleased to have been invited to showcase the company’s success over the last 6 years. The 1-day conference allows for significant networking opportunities and brings together international investors and companies seeking finance. It is aimed at highlighting the wealth of life science investment opportunities in the North of England and generally raising the national and international profile of the sector.

Blueberry Therapeutics are delighted to welcome Dave Edwards as Pharmaceutical Development Director, where he is responsible for CMC aspects of the manufacture of clinical supply materials through Phase II and III studies as well as subsequent commercialisation. Prior to this, Dave was Development Manager for Teva Pharmaceuticals for 10 years, specialising in development and bioequivalence of complex formulations. Before that, Dave gained his Ph.D from Manchester University in medicinal organic chemistry, and previous to that a 1^st Class honours degree from Imperial College in Chemistry. Dave enjoys drumming in a local band and fell running.

We are delighted to welcome Jessica Harrison to the Blueberry team as an Office Assistant. Jess has vast experience in IT and holds a degree in Video Game Design. Outside of work, Jess likes to create concept art, pet cats and bake cakes.

We are delighted to welcome Diane Lee to the Blueberry Clinical Team. Diane has over 15 years’ experience in clinical research in different settings; Clinical Research Organisations, pharmaceutical companies and academic research.  She has a science background with a BSc in Zoology and a PhD in developmental neuroscience. In her spare time, Diane enjoys running and learning Spanish.

Blueberry Therapeutics would like to extend a warm welcome to our newly appointed Regulatory Affairs Director, Anita Murray. Anita has an extensive background in both pharma and academia and brings with her many years of experience in Regulatory Compliance, managing agency interactions and in the preparation and submission of Clinical Trial Applications. In her spare time, Anita enjoys walking, cycling and helping to run the local Scout group. Welcome Anita!

Blueberry Therapeutics are delighted to welcome Heather Davies to the team as an Analytical Scientist. Heather is a biochemist by training and joins Blueberry after completing a post doc in France. She brings with her a wealth of experience from across a variety of scientific disciplines within biology, chemistry and physics. In her spare time Heather enjoys hiking, home brewing and baking.

Blueberry Therapeutics would like to extend a warm welcome to Christian, who joins us with a wealth of experience as a Senior Clinical Project Manager. Christian has over 15 years’ experience in the pharmaceutical industry; three years in pipeline drug development, seven years in clinical project management and three years as a Clinical Research Associate. Christian has a background in early phase drug discovery after graduating with honours in Human Physiology and Pharmacology. In his spare time, Christian has a keen interest in sailing and motorsport.

Blueberry CEO, John Ridden, will be attending the 2nd Dermatology Drug Development Summit in Boston, 27-29^th November 2018. The event is a unique industry-led conference focusing on innovating & accelerating the development amd commercialisation of dermatological medicines.

Alderley Park, UK, 21^stNovember 2018– Blueberry Therapeutics Limited (“Blueberry Therapeutics”), a modern drug discovery and development company committed to the development of innovative new therapies for the treatment of common and difficult to treat dermatological disorders, today announces that BB2603 has successfully met its primary endpoint from the recently completed Phase I/II trial of 46 patients with both onychomycosis (fungal nail infection) and concomitant tinea pedis (athletes foot).

The trial was a single centre, vehicle and active controlled, randomized investigation, undertaken in Germany, with primary endpoints of systemic pharmacokinetics and secondary endpoints in safety and local tolerability. Efficacy signals were assessed at day 42 for tinea pedis and week 52 for onychomycosis.

The study met all its primary and secondary endpoints to assess pharmacokinetic, safety and local tolerability. The topical nano-formulation BB2603 was shown to have an excellent safety profile with good local tolerability and no systemic exposure. Efficacy assessments were highly encouraging with demonstrable anti-fungal activity against dermatophytes, the causative pathogens for both onychomycosis and tinea pedis. Clinical improvements were noted in both indications.

John Ridden, CEO, commented “we are delighted that our Phase I/II trial of BB2603 has met both its primary and secondary endpoints and that we are able to use our nanotechnology platform to develop medicines such as BB2603 for diseases where there is a significant medical need, particularly where improved drug delivery or optimised treatment regimes can overcome tolerability and safety concerns and better suit the patient needs”.

Blueberry Therapeutics has a number of pipeline treatments focussing on common high value dermatological diseases where there is a significant clinical need […]

John Ridden, Blueberry CEO will be attending BIO International convention in Boston, 4th-7th June. 2018 is the 25th year for the BIO Convention, and attracts more than 16,000 biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships.

John Ridden, David Cook and Mark Hollingworth will be attending BioTrinity London 23-25 April. BioTrinity is Europe’s leading biopartnering and investment conference, and is in its 12^thconsecutive year. The theme for 2018 is “Next Generation Healthcare”. We look forward to seeing you there!