Staidson links with Pivotal to test BDB-001 in severe COVID-19 patients

Shares of China-based biotech Staidson (SHE: 300204) closed down 2.14% at 10.99 renminbi today, after it said it has partnered with Spanish full-service contract research organization (CRO) Pivotal 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 pre-clinical 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, according to Staidson. 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.

BDB-001 already tested in over 69 healthy volunteers

“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, 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,” he added.

Dr Lourdes Huarte, vice president of regulatory and clinical operations at Pivotal, commented: “The challenge of this trial was to mobilize enough experienced resources working in parallel in a record timeframe to finalize the protocol, expeditiously secure the approval of the Competent Authorities and Ethics Committees, perform the feasibility to select the appropriate centers, select a central laboratory, and line up all resources to activate enrollment and launch the trial while the pandemic is progressing in Europe.”