Monday 20 July 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Positive results from trial of SNG001 in hospitalised COVID-19 patients
Patients who received SNG001 had a 79% lower risk of developing severe disease compared to placebo
Patients who received SNG001 were more than twice as likely to recover from COVID-19 as those on placebo
A briefing for journalists will be held via webinar at 12:30 BST today
Synairgen plc, the respiratory drug discovery and development company which originated from research at the University of Southampton, announced positive results from its clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalised COVID-19 patients.
Richard Marsden, CEO of Synairgen, said:
"We are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalised COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation’. It also showed that patients who received SNG001 were at least twice as likely to recover to the point where their everyday activities were not compromised through having been infected by SARS-CoV-2. In addition, SNG001 has significantly reduced breathlessness, one of the main symptoms of severe COVID-19. This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalised COVID-19 patients. Our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible."
The double-blind placebo-controlled trial recruited 101 patients from 9 specialist hospital sites in the UK during the period 30 March to 27 May 2020. Patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG001).
The odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were significantly reduced by 79% for patients receiving SNG001 compared to patients who received placebo (OR 0.21 [95% CI 0.04-0.97]; p=0.046).
Patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period compared to those receiving placebo (HR 2.19 [95% CI 1.03-4.69]; p=0.043).
Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.007).
Three subjects (6%) died after being randomised to placebo. There were no deaths among subjects treated with SNG001.
In the patients with more severe disease at time of admission (i.e. requiring treatment with supplemental oxygen), SNG001 treatment increased the likelihood of hospital discharge during the study, although the difference was not statistically significant (HR 1.72 [95% CI 0.91-3.25]; p=0.096). Median time to discharge was 6 days for patients treated with SNG001 and 9 days for those receiving placebo. Furthermore, patients receiving SNG001 appeared to be more than twice as likely to have recovered by the end of the treatment period (HR 2.60 [95% CI 0.95-7.07]; p=0.062), although this strong trend did not reach statistical significance. However by day 28, patients receiving SNG001 treatment had statistically significantly better odds of recovery (OR 3.86 [95% CI 1.27-11.75]; p=0.017).
Interestingly, the efficacy analyses indicate there is no evidence of an association between the SNG001 positive treatment effects and prior duration of COVID-19 symptoms.
Further analysis will be conducted over the coming weeks and reported in due course.
Inland Homes (INL.LSE)
Inland Homes signs £49m agreement with B3Living
Inland Homes plc, the leading brownfield developer, housebuilder and partnership housing company with a focus on the south and south-east of England, today announced that it has exchanged unconditional contracts via its joint venture, Cheshunt Lakeside Developments Limited, to sell Phase 1a at its Cheshunt Lakeside, Hertfordshire project to a local housing association, B3Living, for £15 million with a payment in full on completion in September 2020.
In addition, Inland Partnerships entered into a contract with B3Living to construct 195 apartments in this Phase in a deal worth £34.5 million. Construction will commence in October this year.
Inland Homes is also pleased to announce the following transactions:
The completion of the sale of a development site in Staines for £6.6 million where Inland has entered into an agreement with the purchaser to manage the planning process and will receive a share of the profits once planning consent is obtained.
The completion of the sale of Burleighfield House in High Wycombe for £1.65 million.
An unconditional exchange of contracts for the forward sale of 24 apartments under construction at its Chapel Riverside development to a housing association for £4.5 million with completion expected in December 2020.
Stephen Wicks, Group Chief Executive commented:
"These recent transactions, at attractive prices and in a difficult economic environment, are a testament to the high quality of Inland's assets.
"The new partnership housing contract with B3Living takes our forward order book in this division to over £100 million.
"We have a number of further significant sales in the pipeline and we will update the market in due course."
B3living's Chief Executive, Steve Woodcock, said:
"This project represents a real milestone for B3Living. This will be our largest project to date and a significant growth for our size.
"This development will also transform the local area and local lives. In our borough, we see many people who can't afford to buy outright or pay private sector rents, so homes like these are desperately needed."
OptiBiotix Health (OPTI.LSE)
Trading and commercial update
OptiBiotix Health plc, a life sciences business developing compounds to tackle obesity, cardiovascular disease and diabetes, provided the following unaudited preliminary revenue figures for the first six months of the financial year and a commercial update.
This update reports on the first six months of this financial year to 30 June 2020. These figures are unaudited and based on invoiced sales from divisional sales reports. They are provided to give investors an insight into the commercial progress of the Company in the current financial year and may differ from reported half year results.
Total invoiced sales of LPLDL® and SlimBiome® as ingredient or final product were £741,504 representing a 398% increase over the H1 period last year (£148,818). The Company is pleased to note the year on year increase in revenue growth from 7.7% (H1: 2017-2018) to 84.7% (H1: 2018-2019) to 398% (H1: 2019-2020) as more agreements generate revenues and partners continue to grow sales from successful product launches.
We are pleased that these preliminary figures show that each division is making progress against the aim of becoming profitable this year. The functional fibres division led by Dr Fred Narbel reported a profit during this period, the ProBiotix division was profitable in three of the six months, and the consumer health division was profitable in one of the six months.
The Company also received £747,500 of investment income in this period from the disposal of shares in SkinBioTherapeutics plc which is not included in these figures.
Investors are cautioned that at this stage of a Company's development, both costs and income can vary widely month to month and the Company is not yet at a stage where it believes half yearly income figures can be extrapolated to full year results.
OptiBiotix has signed 15 commercial agreements in this period, 11 for SlimBiome®, and four for LPLDL®. Of particular note are the deals with Holland and Barrett, Optipharm, and USA partners opening up retail opportunities in the UK, Australia, parts of Asia, the Middle East, and North America. Announcing deals increases industry awareness of OptiBiotix's brands within the industry and changes the nature of partner discussions as the commercial benefits are established in more territories. Growing brand awareness increases the value of a product, and ultimately shareholder value, and is particularly important and valued by large corporates. This is in line with our strategic aim of growing the awareness of our brands around the world.
Sales of LPLDL® as an ingredient or final product grew by 477% compared to the same period last year. Of particular note was the successful launch of AlfaSigma's Ezimega 3 product and the commercial growth of Seed Health's Daily Synbiotic. Post period, the signing of an agreement with Actial Farmaceutica Srl for the distribution of CholBiome® products was a significant achievement and brings further credibility to the LPLDL® brand. Actial is the developer of one of the world's best-known probiotic brands - VSL#3® and their products have a reputation for their strong science and clinical studies amongst hospital clinicians, GPs and pharmacists. LPLDL® is now building an industry brand presence with a growing list of pharmaceutical partners who recognise the value of a natural product with a known mechanism of action, human studies, and a portfolio of trademarks and patents which protect their commercial interests. In addition to growing interest from pharmaceutical groups commercialising LPLDL® as a supplement, it is being used in a wide range of other applications. These include dairy (RNS: 12 February 2020), anti-aging products and with a blood pressure, CholBiomeBP, and vascular health product CholBiomeVH, to be launched with partners later this year. This will complete a suite of cardiovascular applications of different formulations which should meet the regulatory and market needs of most countries around the world.
Sales of SlimBiome®as an ingredient or final product grew by +1,309% compared to the same period last year. This was largely driven by partners in the UK, Australia and the USA either launching retail products or building stock levels for launch of products. Of particular note is the extension of SlimBiome®into everyday foods like muesli and porridge and the development of healthy snacks like fruit and fibre gummies under the SnackSmart® brand. The launch of WellBiome® at the end of the period reflects the growing interest from partners in a science backed Health and Wellbeing microbiome product which taps into a global trend for Health & Wellness industry, a market estimated to be worth US$4.2 trillion in 2019 with the digestive health segment accounting for US$60 billion.
SweetBiotix ® are a family of products based on a concept of creating a sweet fibre that has a low glycaemic index which enhances the microbiome. The concept uses new science, new manufacturing processes, and is a step change from existing products on the market or known to be under development. This creates a large opportunity but a challenge working with multiple partners on application opportunities as diverse as dairy, cereals, and hot & cold beverages. Each of these have to be assessed in terms of flavour optimisation (as this will depend on the food matrix), stability (which is different in a yoghurt to an acidic carbonated beverage), dosage (which will effect cost and sweetness levels), safety, tolerance, health benefits, and the final product cost profile.
One SweetBiotix ® product has undergone pilot manufacturing scale up and OptiBiotix raised funds in April 2020 to scale up additional SweetBiotix®products with partners.
Discussions with manufacturing and application partners are taking place against a background of development and optimisation under heads of terms or 'open innovation' arrangements. These allow parties to share information and samples whilst protecting OptiBiotix's IP in an area increasingly seen as of growing strategic importance to the industry. Larger partners often want exclusivity for the complete SweetBiotix® portfolio to protect their commercial interests. An agreement with a single partner would be simpler and quicker but could potentially limit the opportunity and create a reliance on a single partner to commercialise. It is in OptiBiotix's best interests to negotiate multiple agreements to reduce this risk. Discussions are taking place with a number of partners within a corporate process and timescale, and are subject to strict confidentiality clauses. We hope to close out one or more agreements within the coming months subject to successful negotiations. Further announcements will be made in due course if or when these discussions materialise into binding commercial agreements.