Open Orphan (ORPH ) said its subsidiary Venn Life Sciences has secured a further contract win to support a Phase II trial in an infectious disease commonly known as ‘river blindness’. 

Venn is to supply consultancy services to support the Phase II trial of an antibiotic drug candidate for Drugs for Neglected Diseases initiative ("DNDi"), a not-for-profit research organisation developing new affordable treatments for neglected patients around the world. 

Onchocerciasis, which is commonly called ‘river blindness’, is a parasitic disease particularly prevalent in Africa, where more than 99% of all cases occur. The disease, which is caused by the filarial worm Onchocerca volvuluscan, cause blindness and permanent skin damage. 

The Phase II study, which has already commenced in the Democratic Republic of Congo, will evaluate ABBV-4083, a product owned by the pharmaceutical company AbbVie and licensed to DNDi, as a potential antibiotic treatment for patients with Onchocerciasis or ‘river blindness’, the second-most common cause of blindness due to infection, after trachoma. 

Open Orphan said Venn’s team in the Paris office will provide support for the Phase II trial. The Company outlined that Venn offers ‘a unique set of high quality, innovative, methodology, data management and biostatistics services utilising the very best technologies and clinical trial expertise to help their clients have access to their data faster and at a lower cost.’ 

Cathal Friel, Open Orphan’s Executive Chairman said ABBV-4083 could be a game-changing drug to help people affected by river blindness in some of the world's poorest nations. 

He commented, "We are delighted to announce another contract win for the business which underpins our confidence in the continued growth we expect to see in 2021. Our teams have a unique knowledge of multiple clinical data management systems and our team of biostatisticians have extensive experience to bring to bear on such studies.” 

Commenting on the win, Sabine Specht, Head of the Filarial Clinical Programme at DNDi, said: "We are delighted that Open Orphan has joined DNDi, AbbVie and multiple partners involved in the development of ABBV-4083 for those at risk or suffering from onchocerciasis.   

The Democratic Republic of Congo is one of the most affected countries by this debilitating disease, so it is especially important that our clinical trials will take place there, where we will be working with national authorities to test out this potentially innovative treatment." 

View from Vox 

The Group told investors in April 2021 that it was at “an advanced stage” of a possible spin out of some of its non-core development intellectual property assets which it believes would be ‘best developed separately from the core services business’ to drive shareholder value.    

Last Monday, Open Orphan’s spin out, Poolbeg Pharma, announced that it had raised £25 million on its first day of dealings as part of its floatation on London’s junior AIM market.  

In recent weeks, the Company has informed investors that it has earmarked some of the £25m proceeds to fund clinical trials for its advanced pipeline therapy for severe influenza.   

Open Orphan said Poolbeg’s IPO comes at a time when, post-pandemic, there has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250 billion by 2025.    

Open Orphan’s Board has said it believes that the assets in Poolbeg would be ‘best developed separately from the core services business’ to maximise shareholder value.    

A spin-out transaction could secure separate financial resources for the assets, enable their accelerated development and achieve commercial milestones, the Company told investors.     

In a research note released at the time, analysts at UK broker finnCap wrote of the news: ‘Having demonstrated its ability to spin-out non-core assets through Poolbeg Pharma, we have confidence in assigning value to Open Orphan’s portfolio of non-core assets.’   

Also commenting on ORPH’s outlook, analysts at research firm Arden Partners said the group’s pipeline is ‘continuing to grow through interactions with key global pharma players with signed deals in 2021 already ahead of 2020, underpinning confidence in the outlook.’     

Reasons to  ORPH

Open Orphan is a rapidly growing Contract Research Organisation and world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials.     

The Group comprises two commercial specialist CRO services businesses, hVIVO and  Venn Life Sciences and is also building out a valuable data platform business. All businesses are now working closely together to offer upselling and cross selling opportunities.      

World Class Facilities     

Open has Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and specialist laboratory facilities. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.      

Largest Test Portfolio     

Open Orphan has a leading portfolio of 8 viral challenge study models, which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March 2020, it is rapidly advancing several COVID-19 challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines.      

hVIVO works with UK and Irish companies to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.      

The company announced that its first volunteer had been dosed with the Codagenix needle free, intranasal COVID-19 vaccine, COVI-VAC as part of a Phase I clinical trial of COVI-VAC currently being carried out by hVIVO, at its facility in the UK.      

Rapidly Expanding Market     

The market for vaccine development and testing has grown rapidly over the past six months, largely due to the outbreak of Covid-19.     

However, ORPH believes Governments and International pharmaceutical companies around the world will be making enormous ‘catch-up investments’ in all types of vaccine development to ensure the effects of any pandemic can be mitigated in the future, which it said should result in the hIVO facility being booked out for months, if not years, in advance going forward.      

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