February 3, 2020 | FDA, clinical trials, drug development, nano technology
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
Alderley Park, UK, January 2020
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.
ENDS
Blueberry Therapeutics Limited Media Contact
Elle Bell – Onyx Health
ebell@onyxhealth.com
Tel: +44 (0) 191 640 3638
Notes to Editors
About Blueberry Therapeutics Limited
Blueberry Therapeutics Ltd., incorporated in November 2011, is a drug discovery and development company focused on developing innovative nanomedicines for difficult to treat skin and nail infections. The company is using its state-of-the-art nanotechnology to develop high value medicines where a reduced dose and improved drug delivery is needed, to overcome existing efficacy, tolerability and safety profile concerns.
Blueberry Therapeutics combines expert in-house resources with selected outsource partners and collaborators to take projects through from preclinical research onto de-risked human clinical proof of concept and then on to the market. For more information, please visit http://www.blueberrytherapeutics.com
This content was provided by Onyx Health
Company Details
Latest Content from Onyx Health
Amid the formidable challenges faced by the NHS, Onyx Health delve into the pivotal role of diagnostics in healthcare transformation, showcasing how collaboration, innovation, and patient-centric approaches are revolutionising healthcare...
Technological advancements are reshaping the healthcare industry. Onyx Health's Medical Education Lead, Sarah Seilly, discusses the innovative techniques at the forefront of enhancing patient care.
Leading healthcare marketing communications agency, Onyx Health, has bolstered its team with the appointment of a new Head of Medical Education, Sarah Seilly. This strategic addition to the team reflects...
Newcastle-based creative agency Onyx Health has continued to grow and expand with the dual appointments of Rosie Thompson as Account Manager and Modupe Ayeni as a Medical Writer
MedTech company PolyPhotonix has had its innovative diabetes sleep mask adopted in the NHS for the first time
Onyx Health has announced the appointment of Trevor Pill as their new Managing Director. He will be taking over the day-to-day running of the agency from owner and founder Karen...
Onyx Health has expanded its digital content team with the appointments of Hope Johnston as Digital Content Manager and Jordan Carr as Social Media Executive.
Onyx Health will be working with Actigen to raise awareness of their innovative clinical trial work in rare diseases and the need to develop new treatment solutions.
Onyx Health continues to expand with six new appointments to its creative and communication teams, due to increased growth in its international client portfolio work.
Onyx Health has teamed up with Diabetes Lifestyle Doctors to tackle the diabetes care gap in the NHS and help patients suffering from type 2 diabetes across the UK. (Pictured...