Staidson and Pivotal to collaborate in European clinical trial of progressive severe COVID-19 patients

  • The phase II, multicentre, open-label, randomised and controlled clinical trial will research whether BDB-001, a recombinant injectable humanised anti-human C5a monoclonal antibody, has a promising role in the treatment of progressive severe COVID-19 patients
     
  • The trial, which plans to include a total of 60 patients in Europe, has recently begun with the first sites initiated in Madrid and will incorporate other European centres
     
  • Click here for image

Beijing, China and Madrid, Spain, 8 June, 2020 – Staidson, a biopharmaceutical company, headquartered in Beijing, developing investigational products by targeting the complement system and Pivotal, a European-wide full-service CRO, headquartered in Madrid, have today announced a new strategic collaboration to assess Staidson´s investigational product BDB-001, a monoclonal anti-C5a antibody, in a Europe-based clinical trial in progressive severe COVID-19 patients caused by SARS-CoV-2.

The cumulative evidence to date suggests that complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other immune-mediated diseases. Currently, seven types of coronaviruses (CoVs) are known to cause human diseases: three of them, recognised as Severe Acute Respiratory Syndrome (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV), and COVID-19 (SARS-CoV-2) have led to more severe clinical outcomes for infected patients. A growing body of evidence indicates that SARS-CoV infection can over activate the complement cascade, thus affecting other organs and producing disease exacerbation. It has been shown that inhibiting the strongest anaphylatoxin C5a can alleviate MERS-CoV-mediated lung tissue damage in infected preclinical models.

If the complement system does in fact promote disease progression post-CoV infection, then inhibiting complement signalling may be an effective approach: in fact, antibodies against C5a can potentially help reduce the pulmonary dysfunction observed in COVID-19 patients. The potential advantage of selectively blocking C5a without affecting C5b pathway is that the complement membrane attack complex (MAC) formation would not be altered, so the protection against several microbial infections such as Neisseria meningitidis would be preserved.

“As one of our products in our pipeline, BDB-001 has been tested in over 69 healthy volunteers and COVID-19 patients in five clinical trials running in China. The promising therapeutic results in severe COVID-19 after BDB-001 compassionate administration has already been accepted for publication by top peer-reviewed journals,” says Dr. Lixin Jiang, MD, PhD, Senior Vice President at Staidson. “We are extremely happy to collaborate with the Pivotal team for clinical trial application in Europe, who have efficiently obtained final approval in less than six weeks and have begun activating sites to enroll patients.”

BDB-001 specifically binds to C5a so that C5a loses its ability to bind to its receptors, thereby blocking its biological functions, such as neutrophil chemotaxis, intracellular lysozyme release, increased levels of inflammatory factors and oxygen Respiratory bursts – while not affecting C5 cleavage and MAC formation.

This clinical trial is a multicentre, open-label, randomised and controlled study to test the safety and efficacy of BDB-001 vs. placebo and Best Supportive Care in severe COVID-19 hospitalised patients who are suffering from severe pneumonia and acute respiratory distress syndrome. Sixty patients will be enrolled in the trial, half of them will be administered the drug and the other half will follow the standard of care used at the corresponding centre.

“The know-how and excellence in clinical research of the clinical investigators´ teams, together with Pivotal's vast experience in the implementation and performance of innovative clinical trials, will allow us to accelerate the research and to quickly test this new treatment regimen. The potential positive results could provide a therapeutic tool available to all clinicians to significantly reduce COVID-19´s mortality,” says Dr. Lourdes Huarte, PhD, Vice President of Regulatory and Clinical Operations at Pivotal. “The challenge of this trial was working in parallel to mobilise enough experienced resources in a record timeframe to finalise the protocol, quickly secure the approval of the Competent Authorities and Ethics Committees, perform the feasibility to select the appropriate centres, select a central laboratory, line up all resources to activate enrollment and launch the trial – all while the pandemic is progressing in Europe.”

 

About Staidson

Staidson is a publicly-traded pharmaceutical company headquartered in Beijing, China, focusing on drug research and development (R&D), manufacturing and sales of innovative medicines with independent intellectual property rights. The company covers early stage exploratory research, drug discovery, process development and pilot scale-up, preclinical biological evaluation, clinical development to drug production and commercialisation. Staidson is an innovative biopharmaceutical enterprise with a complete biopharma industrial chain, R&D facilities, production and marketing systems. Staidson is a listed company on the Shenzhen Stock Exchange, China and a national high-tech enterprise.

 

The company is committed to R&D, production and sales of therapeutic drugs with unmet medical needs, mainly including biological (therapeutic monoclonal antibody drugs), gene/cell therapy, and small molecule drugs. The therapeutic field covers several therapeutic areas such as CNS, infectious, gastrointestinal, urinary and autoimmune system diseases.

 

For more information, please visit www.staidson.com

 

About Pivotal

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognised the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the “co-thinkers” for their clients, through its strategic scientific advice. To date, we are the trusted adviser and counsellor for many companies to deliver maximum value in their drug and medical devices development programs. We are a leading privately held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.

Pivotal´s client portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, as well as independent investigators and cooperative groups. We have long-standing relations with over 200 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customised teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers' most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our clients' preferred outsourcing solution partner.

For more information, please visit http://www.pivotal.es

MEDIA CONTACT
Ms. Natalia Farr
M.: +34 679 488 022
natalia.farr@pivotalcr.com

To read more Press Release articles, click here.