Blueberry Therapeutics receives clearance from the FDA to proceed with the clinical investigation of BB2603

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.

2020-01-28T09:58:10+00:00January 28th, 2020|Latest News|

Blueberry Therapeutics Appoints Dr. Adrian Howd to Board of Directors

Drug discovery and development company Blueberry Therapeutics announced the appointment of Dr. Adrian Howd to its Board as an independent Non-Executive Director, strengthening its strategic, financial and therapeutic expertise 

Dr. Howd has over 20 years’ experience in the life science sector. He has held various private and public company Executive and Board roles in the UK, EU and USincluding ImmunocorePoseida TherapeuticsViamet and MalinAs CEO of Malin, he led equity capital raises totalling EUR 430and implemented the operational and strategic refinement and priority asset focus for the company.  

Prior to this, Dr. Howd also held numerous investment andfinance roles within global financial institutions. He received his PhD in Neuroscience from St. Thomas’s Hospital, University of London and undertook a postdoctoral fellowship at the National Institutes of Health, Bethesda Maryland. 

Andrew Kay, Chairman, said: “We are delighted to welcome Adrian to our Board and I am certain he will provide Blueberry Therapeutics with solid counsel. He has a proven track record of working with fast growing companies, including those witdermatology and anti-infective focus 

“Adrian’s experience of senior Executive and Board roles and numerous investment and financing roles will help to drive the company forward and achieve our continued success. 

2020-01-15T13:12:58+00:00January 15th, 2020|Latest News|

Blueberry Therapeutics completes BB2603 Investigator meeting

The Blueberry Therapeutics project team along with CEO John Ridden, and their partner Iqvia Biotech, held an Investigator meeting in Vienna, Austria on November 8th 2019. The meeting was attended by over 50 site staff from both private and hospital based dermatology clinics across Poland, Czech Republic and Germany, and was the first opportunity for the Principal investigators to meet face-to-face with Blueberry Therapeutics. The Investigator meeting is a major step in kicking off the Phase  II study in Onychomycosis and the feedback from the event was hugely positive, with real enthusiasm for the study and future potential. BB2603, which is a nanoformulation of Terbinafine, will be evaluated in a Phase II clinical trial focusing on efficacy and safety.

2019-11-15T13:42:27+00:00November 15th, 2019|Latest News|

Blueberry Therapeutics extends a warm welcome to Emma Leigh

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 Medical Writing Lead Emma Leigh

2019-10-28T13:24:30+00:00October 21st, 2019|Latest News|

John Ridden invited to showcase Blueberry’s success at BioCap

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.

 

2019-09-25T09:25:50+00:00September 25th, 2019|Latest News|

Dave Edwards joins Blueberry Therapeutics

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 1st Class honours degree from Imperial College in Chemistry. Dave enjoys drumming in a local band and fell running.

Dave Edwrds e1563269258190

 

2019-07-16T09:28:46+00:00July 1st, 2019|Latest News|

Diane Lee joins the Blueberry team

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.

diane e1562187601377

 

2019-07-03T21:01:54+00:00June 4th, 2019|Latest News|

Anita Murray joins the Blueberry team as a Regulatory Affairs Director

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!

Anita Murray

2019-06-24T07:17:26+00:00June 3rd, 2019|Latest News|

CEO Dr. John Ridden talks Biotech Strategy & Nanomedicine

Blueberry Therapeutics’ CEO, Dr. John Ridden sat down with Pharmaphorum’s Dominic Tyer to talk strategy and bringing innovation to life through Blueberry Therapeutics’ nanomedicine approach. Dr. Ridden also spoke about the concept of risk management in small biotech companies and the latest funding deal with China Medical Venture Investment (CMS).

Listen to the podcast here: https://pharmaphorum.com/r-d/biotech-strategy-and-nanomedicine/

2019-02-08T13:11:03+00:00February 8th, 2019|Latest News|

Blueberry Therapeutics welcomes Heather Davies!

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.

Heather

2019-02-08T13:02:24+00:00January 7th, 2019|Latest News|

Blueberry Therapeutics wins Bionow’s Company of the Year Award

Alderley Park, UK, 4thDecember 2018– Blueberry Therapeutics won the coveted ‘Company of the Year’ award after another remarkable year of progress and innovation. 2018 has seen many great achievements for Blueberry Therapeutics including the completion of £10m Series B Fundraising with investment from China Medical Venture Investment (HK) Limited alongside the recently announced BB2603 Phase I/II trial reaching all primary endpoints in patients with both onychomycosis (fungal nail infection) and concomitant tinea pedis (athletes’ foot).

The 17thannual Bionow Awards were held this year at the Mere Golf Resort and Spa on Thursday 29thNovember. The companies involved in the awards are all leaders in the North’s life sciences sector, which is worth more than £13bn to the economy.

David Cook, Chief Scientific Officer at Blueberry Therapeutics said he was ‘truly honoured by the award and the recognition of the team’s outstanding expertise and achievement’. He believes that the award supports Blueberry Therapeutics’ overarching vision ‘to bring high value, innovative medicines to the market’ and is excited to share future programme developments in 2019.

Geoff Davison, CEO of Bionow, congratulated Blueberry Therapeutics and the other winners on the night and said: “The 2018 Awards reflect the superb efforts by companies in the Life Sciences sector in the North to innovate and commercialise great ideas and IP into new medicines and treatments.”

Rowena Burns, Chair of sponsor Manchester Science Partnerships, added: “This has been a landmark year for the life sciences sector in the North. Confidence amongst investors is high, and company growth rates are strong.

The 17thannual awards were a fantastic success and accurately showcased the excellence […]

2018-12-19T08:29:46+00:00December 19th, 2018|Latest News|

Noria joins Blueberry as a CRA

Blueberry Therapeutics are delighted to welcome Noria Mbuisa to the team! Noria joins us as a Clinical Research Associate, where she leads the review of study regulatory documents and data analysis.

Noria has a Bachelor of Science Hons degree in Pharmaceutical Science from the University of Huddersfield, which led to a career in clinical research.

Before moving to Biotech, Noria’s clinical research experience has been with the NHS, Global Pharma organisations, and Clinical Research Organisations. She also has over 15 years’ experience in health and finance sectors. In her spare time, Noria loves to dance and also knits clothing for her local Neonatal Unit.

Noria

2018-12-18T08:31:40+00:00December 10th, 2018|Latest News|

Blueberry Therapeutics welcomes Christian Little to the team

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.

 

cl

 

2018-12-18T08:26:22+00:00December 4th, 2018|Latest News|

Blueberry Therapeutics Announce Positive Results from a Phase I/II Clinical Trial

Alderley Park, UK, 21stNovember 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 […]

2018-11-21T15:03:08+00:00November 21st, 2018|Latest News|

CSO David Cook presents at ELRIG Drug Discovery Conference

David Cook presented at the recent ELRIG (European Laboratory Research and Innovation group) Drug Discovery Conference. David was invited to present in a workshop called “Build Biotech Success: A practical case study with CROs at Alderley Park”. The session focused on how Blueberry Therapeutics has grown as a business and how it successfully develops partnerships and collaborations to help deliver our drug programs.

2018-12-13T13:35:52+00:00October 11th, 2018|Latest News|

Blueberry Therapeutics Limited closes £10m funding to support development of nanomedicines portfolio

Alderley Park, UK, 14 August 2018– Blueberry Therapeutics Limited, (“Blueberry Therapeutics”) a drug discovery and development company focused on developing innovative nanomedicines for difficult to treat skin and nail infections, today announces that it has successfully completed its £10m Series B Fundraising with investment from China Medical Venture Investment (HK) Limited, a wholly owned subsidiary of China Medical System Holdings Limited (“CMS”), and A&B (HK) Company Limited (“A&B”).

Blueberry Therapeutics will use the net proceeds of the Series B Fundraising to fund its development programme for BB2603 for the treatment of onychomycosis and tinea pedis, as well as progressing its earlier stage acne, topical analgesia and atopic dermatitis programmes.

The company’s vision is to discover, develop and bring to market high value nanomedicines that will overcome existing efficacy, tolerability and safety profile concerns and positively impact on treatment outcomes.

Blueberry Therapeutics has a number of pipeline nano-formulated treatments focussing on skin and nail infections where there is a significant clinical need for treatments with improved efficacy, safety, tolerability and patient compliance.

BB2603 (terbinafine-nano) is Blueberry Therapeutics’ lead development drug candidate and will complete a Phase II dose finding study as we approach Phase III clinical development in the US and EU for the treatment of onychomycosis. BB2603 is a novel topical nanoformulation of the established antifungal terbinafine, delivered as a hand pump spray.

Using nanotechnology, BB2603 is designed to greatly enhance delivery of terbinafine to target fungal infection under the nail. BB2603 aims to demonstrate equivalent efficacy and treatment duration but at a dose which is several thousand-fold lower than documented for oral terbinafine, thereby […]

2018-08-14T13:28:49+00:00August 14th, 2018|Latest News|

CEO attending BIO International, Boston

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.

2018-06-06T10:59:40+00:00May 29th, 2018|Latest News|
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