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So far Susan Yau has created 56 blog entries.

Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis

Primary endpoint (negative culture and/or clear nail growth) met with 83.3% response rate 

Secondary endpoints met at Week 52 after 9-months off treatment

Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical nanomedicines to treat dermatological conditions, announces that BB2603, a novel topical terbinafine antifungal product, has met the primary endpoint in the Phase 2b trial (BBTAF202) in patients with onychomycosis, showing superiority over placebo (vehicle) with a high level of statistical significance.

BBTAF202 was a European trial conducted in 111 subjects with mild to moderate distal subungual onychomycosis (DSO) of the toenail, recruited from sites in Germany, Poland and the Czech Republic. This trial assessed the efficacy, safety and pharmacokinetics of 3 months twice-daily treatment of BB2603-10 versus vehicle, along with 2 lower formulation strengths of BB2603-3 and BB2603-1. A 3‑month treatment duration is considerably shorter than for other topical agents used for onychomycosis (~11 months).

The primary objective was an assessment of early clinical and/or mycological activity of BB2603-10 versus vehicle at Week 16, 1 month after end of treatment. Significantly more subjects treated with BB2603-10 (83.3%) had a response of negative dermatophyte culture and/or clear nail growth at Week 16 compared with those who received vehicle (51.8%, p=0.004). This treatment difference was driven by an early effect of BB2603-10 on negative culture (80.6% vs 40.5%, p<0.001). Growth of clear nail was observed in many subjects as early as Week 4. Clear nail and improvement in the appearance of fungally-infected toenail addresses an important aesthetic need of patients.

2023-11-13T09:28:27+00:00November 13th, 2023|Latest News|

A warm welcome to Megan!

Megan Dawson October 2023

We’d like to extend a warm welcome to our new Laboratory Technician, Megan Dawson. Megan joins us with a Masters in Medical Microbiology from the University of Manchester, and after gaining lots of relevant skills in an associate practitioner role at Alder Hey Children’s Hospital. In her spare time, Megan’s interests include attending festivals and gigs, and reading (she is a huge Harry Potter fan). Welcome to Blueberry, Megan!

2023-10-31T14:29:43+00:00October 17th, 2023|Latest News|

Phase 2b Trial in Fungal Nail Infection Completed

Alderley Park, 04 July 2023 – Blueberry Therapeutics is pleased to announce the completion of our European Phase 2b trial of BB2603 (BBTAF202). This trial is assessing the efficacy and safety of different doses of BB2603, a new topical anti-fungal spray formulation, in subjects with fungal nail infection (onychomycosis). The last subject entered has attended their last visit for the final Week 52 endpoint. We now turn our attention to preparing for the trial results. We would like to express our gratitude to all sites and participants for their continued involvement through this year-long trial period.

2023-07-04T15:23:13+00:00July 4th, 2023|Latest News|

Nature’s Nanotechnology

Nanotechnology is a revolutionary field of science and technology, with significant developments over the last few decades spanning medicine, cosmetics, agriculture, and engineering. The simple definition of ‘nano’ means particles sized 1 to 100 nm (1 billionth of a metre, not even visible with standard microscopy). They have a large surface area to volume, which can alter properties such as strength, dynamics, stability and reactivity – and it is this that makes them of huge scientific interest. It is often assumed that ‘nano’ always means ‘artificial’ or ‘engineered’. That’s not the case – nanoparticles are all around us in the natural world and have been for billions of years. Indeed, nature has been described as an ‘excellent nanotechnologist’.

In the atmosphere
Volcano erupting ash
The land, sea and air are rich in examples of nanomaterials. In the atmosphere, nanoscopic ash or soot particles are present due to volcanic activity or near open fires, and dust storms from deserts contain many mineral-based nanoparticles. Mineral springs are full of nanoscopic solid material, and clay is a natural nanomaterial, made of silicon, aluminum and hydroxyl components forming sheets of nanometric size. These sheets give plasticity to the clay when wet, which then hardens upon drying or firing.

In living organisms…

Nanotechnology is also an integral part of the living world. The living cell is microscopic in size (animal and plant cells are in the range of 0.01 – 0.10 mm, and bacteria are smaller), but many biological processes involve nanoparticles. A remarkable example is […]

2023-04-24T16:02:45+00:00April 24th, 2023|Blog Articles|

Update on Phase 2b Trial in Fungal Nail Infection

Alderley Park, 17 February 2023 – Blueberry Therapeutics is pleased to announce further progress on our Phase 2b European trial of BB2603 (BBTAF202). We previously announced the completion of recruitment, and we now provide an update that the final subject in this trial has passed through the Week 16 primary endpoint assessment time point.

This trial is assessing the efficacy and safety of different doses of BB2603, a new topical anti-fungal spray formulation, in subjects with fungal nail infection (onychomycosis). These subjects will continue through to the end of this 1-year trial, when the trial will readout and we will assess final efficacy and safety. We would like to express our gratitude to all participants for their continued involvement.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

2023-02-17T11:12:56+00:00February 17th, 2023|Latest News|

Blueberry Therapeutics Announce Nomination of BB1511 for Clinical Development for the Treatment of Atopic Dermatitis (Eczema)

Alderley Park, 22 November 2022 – Blueberry Therapeutics are pleased to announce that their novel cream formulation for the treatment of atopic dermatitis (BB1511) has been nominated for clinical development.

This nomination decision was unanimous following review of pharmaceutical development and pre-clinical data, which demonstrated the required drug attributes to progress towards regulatory advice and then clinical trials. The nomination of BB1511 followed on from the development of BB0107, which although did not quite meet our high standards for nomination, provided valuable insight to allow us to adapt the formulation development for BB1511.

BB1511 is a light cream formulation designed to support skin barrier function whilst reducing the inflammation associated with atopic dermatitis, which we hope will help many patients in managing their disease more effectively.

BB1511 adds to our expanding drug portfolio in the clinical phase (alongside BB2603 for onychomycosis and BB1202 for tinea pedis).

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic […]

2022-11-22T14:07:04+00:00November 22nd, 2022|Latest News|

A new Analytical Scientist joins the Preclinical team

Blueberry extends a warm welcome to Sinead Sunner, who joins our preclinical team as an Analytical Scientist. Since graduating with an MSc with Honours in Medicinal and Biological Chemistry from the University of Nottingham, Sinead has worked at LCG in Cambridge and Alderley Analytical here at Alderley Park. Sinead describes herself as having a passion for physical and medicinal chemistry! In her free time, she grows her own chilli plants and plays women’s football.

Welcome to Blueberry Sinead!

2022-10-27T12:51:13+00:00October 27th, 2022|Latest News|

Blueberry Therapeutics Announce Recruitment Complete to Phase 2b Trial

Alderley Park, 29 July 2022 – Blueberry Therapeutics are pleased to announce that recruitment into our Phase 2b European trial of BB2603 for fungal nail infection is now complete.

This trial (BBTAF202) assesses the efficacy and safety of different doses of BB2603, a new topical anti-fungal formulation, in patients with fungal nail infection (onychomycosis). Data from the primary endpoint (an early response assessment at 16 weeks) are expected in Q1 2023, with final results to follow for the 52-week endpoints.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic dermatitis (eczema).

2022-07-29T11:28:23+00:00July 29th, 2022|Latest News|

Blueberry Clinical Trial Data Published in the Journal Mycoses

We are delighted to share that the results from our Phase 1/2 trial of BB2603 in subjects with onychomycosis (fungal nail infection) and tinea pedis (athlete’s foot) have now been published in the peer-reviewed journal, Mycoses.

BB2603 is our topical formulation of the antifungal agent terbinafine complexed with a polymer that enhances delivery through the nail and into the upper layers of the skin.

In summary:

  • BB2603 was shown to be safe and very well-tolerated, with active drug detected at the site of infection (nail) and not in circulation.

  • There was impressive anti-mycological activity seen, especially in eradication of the causative fungi.

  • BB2603 is a promising topical drug, and further trials in OM and TP are either ongoing or planned. See our clinical trials page for details of our ongoing European Phase 2 trial in onychomycosis.

For a read-only copy of the paper, click here.

We would like to thank all the patients who participated in this trial.

2022-05-25T10:41:41+00:00May 25th, 2022|Blog Articles|

Blueberry Therapeutics Provides Regulatory Update on Phase 2b Trial

Alderley Park, 24 May 2022 – Blueberry Therapeutics are pleased to report significant progress in our Phase 2b European trial of BB2603 in onychomycosis (BBTAF202).

The COVID-19 pandemic led to operational challenges in all 3 participating countries (Germany, Poland and Czech Republic) – including a trial pause to ensure patient and site staff safety. Blueberry has worked creatively to implement strategies to boost patient numbers and minimise delays, including protocol changes and roll-out of a multi-media advertising campaign to increase awareness of clinical research in this area. These have required multiple regulatory submissions to notify or obtain approval from Ethics Committees and Competent Authorities. We are delighted to share that the final approval in this jigsaw has been received and recruitment is expected to complete in July 2022. The primary endpoint is expected 1Q23.

For more information about Blueberry Therapeutics please contact:

Dr Emma Leigh, Director of Communications

info@blueberrytherapeutics.com

About Blueberry Therapeutics

Blueberry Therapeutics is a pharmaceutical company focused on the discovery, development and commercialisation of high value medicines for the treatment of common dermatological conditions that will positively impact on treatment outcomes and improve patient quality of life.

Blueberry applies innovative technologies to improve the delivery of existing drugs through the skin and nail. This enables better efficacy, safety and patient compliance while reducing drug dosage and cost of goods. The Company has a de-risked portfolio of best-in-class [advanced stage] clinical and preclinical assets addressing high value and poorly served indications in dermatology, including onychomycosis (fungal nail infection), tinea pedis (athletes’ foot) and atopic dermatitis (eczema).

2022-05-25T09:44:07+00:00May 25th, 2022|Latest News|

Blueberry Therapeutics provides R&D update and reports progress across dermatology portfolio

  • Phase 2 trial with BB2603 in onychomycosis: continues, with initial readout expected in Q1 2023
  • Phase 3 trial with BB1202 for tinea pedis: ready to enter late-stage clinical development with Blueberry seeking advice from regulatory agency to finalise trial design
  • Phase 1 trial with BB0107 for atopic dermatitis: expected to move into the clinical phase in the second half of 2022

Alderley Edge, 24 March 2022 – Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical medicines to treat dermatological conditions, today provides an update on its research and development activities. The Company is progressing a de-risked portfolio of best-in-class assets addressing high value markets, including onychomycosis (fungal nail infection), tinea pedis (athlete’s foot) and atopic dermatitis (eczema).

Blueberry has applied innovative formulation technologies to improve the delivery of existing drugs through the skin and nail. These enhanced formulations support better efficacy, safety and compliance, representing significant improvements over existing prescribed and over-the-counter treatments, with the potential to reduce dose and cost of goods.

Dr John Ridden, CEO of Blueberry Therapeutics, commented:

 “Over the past year, we have made significant clinical progress with our lead programmes, BB2603 for onychomycosis and BB1202 for the treatment of tinea pedis, with further important milestones expected this year. We anticipate that recruitment into our ongoing Phase 2 study with BB2603 will be complete by July 2022 with the primary endpoint data anticipated in Q1 2023.

 “For BB1202, in tinea pedis, we are currently designing a Phase 3 clinical programme to support registration, with the aim of initiating a Clinical Trial Application in […]

2022-03-30T08:04:29+00:00March 24th, 2022|Latest News|

The Blueberry Team complete 546 km challenge to raise money for In2Science!

From the 19-25th April, Blueberry employees took on a challenge to collectively reach a target distance of 200 km in one week to raise money for the charity In2Science. Our active bunch answered this call by walking, running, swimming, cycling, rowing and kayaking and went above and beyond our target to reach a final distance of 546 km! In doing so we have raised £1,412 in sponsorship for In2Science, who improve access and remove barriers to STEM careers to young people from low income and disadvantaged backgrounds. Blueberry will top up this fundraise to donate a total of £2,000 for this great cause!

Blueberry will also join the mentorship program run by In2Science later this year, to mentor Year 12 students in the North West – a program which has already had great success in other parts of the UK where 83% of students who have taken part have progressed to University. We’re proud to contribute to this great cause and help the next generation of scientists, engineers and mathematicians.

2021-05-10T10:14:53+00:00May 6th, 2021|Latest News|

Blueberry Therapeutics announces extension of its Series B round with investment from Medical Incubator Japan and US Dermatology Syndicate

Blueberry Therapeutics Limited would like to announce that it has completed a £3.6m extension to the previously successful Series B Fundraising of £10.8m. This investment is from a Japanese investor, Medical Incubator Japan (MIJ) and a private syndicate of US Board Certified Dermatologists led by Dr Omar Ibrahimi of Stamford, CT. Blueberry Therapeutics is a dermatology-focused drug discovery and development company focused on developing innovative nanomedicines for difficult to treat diseases of the skin and nail, with a lead candidate in Phase II development.

The fundraise is partly in response to the COVID-19 pandemic, which has affected clinical trials globally, but primarily because of a series of pre-clinical successes during 2020, which have broadened the company’s drug portfolio. Blueberry Therapeutics will use the Series B extension proceeds to continue its development programme for BB2603 for the treatment of onychomycosis, and additional funding will be used to advance other programmes, including in tinea pedis, where there are encouraging efficacy and safety data, and a potentially efficient route to market.

BB2603 is Blueberry Therapeutics lead development drug candidate; after completing a Phase I/II study in 2018, this is now in Phase II clinical development. Using nanotechnology, BB2603 is designed to greatly enhance delivery of terbinafine to target fungal infection under the nail and within the upper layers of the skin. In onychomycosis, BB2603 aims to achieve equivalent efficacy and treatment duration but at a dose which is several thousand-fold lower than approved for oral terbinafine, thereby avoiding the systemic side effects and patient monitoring requirements of oral administration. The additional funding supports completion of […]

2021-05-18T14:01:03+00:00January 29th, 2021|Latest News|

Blueberry expansion at Alderley Park

Blueberry expansion at Alderley Park. The Blueberry team are delighted to be moving into a larger, more spacious office area on the Alderley Park site, with views over the Cheshire plains. The move will bring the whole team together into one office, and provides space for further expansion, with integrated meeting rooms and a board room.

Office viewView of offices

2021-05-13T10:12:59+00:00September 23rd, 2020|Latest News|

COVID-19: We all have skin in the game

Blueberry Therapeutics is a drug development company committed to finding new and improved treatments for a range of dermatological conditions affecting the skin and nails. The future and long‑term effect of the global COVID-19 pandemic (caused by severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2 virus]) on dermatology practice and skin health is still unknown, but here we provide some insights on the potential challenges for dermatology patients and practitioners.

Skin diseases are frequently neglected as they are not an immediate threat to life, and do not generally cause serious complications or require hospitalisations. Lockdown and other measures implemented in many countries to reduce the spread of SARS-CoV-2 infections and protect people and healthcare resources, have led to a notable decrease in the number of patients attending face-to-face outpatient dermatology consultations, both in hospitals and in specialist clinics1,2. Although teledermatology appointments (using telecommunication technology) have been recommended and successfully implemented to allow consultations3, there is concern of a build-up of undiagnosed and untreated skin conditions. These may become more burdensome and some cases may require urgent medical attention if patients continue to be unable to seek help. Some inflammatory skin diseases, such as psoriasis or atopic dermatitis, are treated with systemic immunosuppressive drugs, which reach the bloodstream and affect the bodies capacity to fight off an infection4. In this COVID‑19 era, patients under treatment with these drugs that work through the modulation of the immune system should be monitored closely, so appointments with their dermatologist are important.

As well as this potential issue of under-diagnosis and undertreatment, there may be a delay in […]

2022-03-24T14:10:32+00:00September 22nd, 2020|Blog Articles|

Senior Analytical Scientist completes LC-MS training

Blueberry’s Senior Analytical Scientist Dr Heather Davies-Strickleton recently attended LC-MS Interpretation Level 1 training. Dr Davies-Strickleton said “This is an exciting opportunity for the Blueberry team to extract as much data as we can from the samples we analyse on our mass spectrometer. This is a vital tool to help us progress our formulations in the early stages of drug development pre-clinically. This training also provides an excellent way for our lab team to enhance their knowledge and expertise, and I look forward to Level 2 training later this month”

2020-09-21T10:40:13+00:00September 21st, 2020|Latest News|

CSO David Cook presenting at Alderley Park Science Seminar series

Dr David Cook

Blueberry’s CSO, Dr David Cook has been invited to present at the Alderley Park Science Seminar series with his talk “Understanding what makes a good drug discovery project: can we ever really predict success?” on Tuesday 21st July 2020 12.00-13.00.

The seminar will be virtual and you can find out more, and register for the event here: https://www.alderleypark.co.uk/events/2020/7/21/alderley-park-science-seminar-series-with-dr-david-cook

2020-07-02T12:32:40+00:00July 2nd, 2020|Latest News|

What is the true burden of nail infections on patients’ well-being?

Written by Emma Leigh, Medical Writing Lead.

Blueberry Therapeutics hopes to make a real difference to the quality of life for people who suffer from skin and nail conditions by curing the symptoms they experience. To do this, it is key to understand exactly what issues affect people with these conditions, how this makes them feel, and how much this impacts their daily way of life.

Our most advanced area of research is fungal infection of the nails, also called onychomycosis, which leads to thickening, splitting, roughening, discolouration and eventually destruction of the nail. This is an extremely common ailment that affects hundreds of millions of people around the world, with prevalence rates up to 23% in Europe, 20% in East Asia and 14% in North America.1 Experts believe that these rates are set to increase even further, partly because of our ageing population, increased migration and changes in lifestyle.

Nail infections should not be considered as simply a cosmetic problem but need to be recognised as an important condition that must be treated. Firstly, for medical reasons as they can lead to more serious infections elsewhere in the body, infections in other family members, and can cause other medical complications. And secondly, as the impact on an individual can be considerable – sadly much greater than is generally recognised. Patients can suffer pain, disability, psychological and social problems, which can affect their work and leisure activities, and ultimately reduce their quality of life.2 Therefore, treatment is key, but importantly, a treatment that fixes the problem without it recurring.

Various studies have assessed the […]

2021-05-18T14:06:53+00:00June 18th, 2020|Blog Articles|

Blueberry publishes latest peer-reviewed scientific paper

Today, Blueberry Therapeutics published our latest peer-reviewed scientific paper. The paper entitled “Assessment of the nail penetration of antifungal agents, with different physico-chemical properties” was published in PLoS One (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0229414) and describes our research into antifungal drugs and their ability to penetrate through human nail. We demonstrate the importance of “water solubility” in dictating the ability of drugs to effectively pass through nail, supporting observations made in other research labs. Chief Scientific Officer, David Cook said “These findings may lead to important new thinking in drug design for nail diseases. It is also great for us to be able to get this research out to the broader scientific community.  This is just one project amongst many exciting programmes at Blueberry and we hope we’ll be sharing more of our research from the team soon.”

 

2020-03-03T10:03:51+00:00February 27th, 2020|Latest News|
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