QUAY EXPERTISE SUPPORTS NEW DRUG FOR TACTIC-E COVID-19 TRIAL

Pharmaceutical outsourcing specialist Quay Pharma’s acknowledged expertise in microbial biotherapeutics has played a crucial role in the development of an experimental therapy with the potential to prevent and treat the complications from COVID-19.

Quay has been working with Evelo Biosciences, Inc, a clinical stage biotechnology company, on Evelo’s EDP1815, which has so far become one of only two drugs to be selected to take part in the TACTIC-E trial. Prof. Sir Mark Walport, at a recent COVID-19 Therapeutic webinar hosted by the BIA, explained the rational behind the choices of the emerging drugs and that over 700 had been reviewed during the process.  

The TACTIC trials (Multi-Arm Therapeutic Study in Pre-ICU Patients Admitted with COVID-19) is being led by the Cambridge Clinical Trials Unit at the Cambridge University Hospitals NHS Foundation Trust. Some people with COVID-19 develop severe symptoms which are thought to be the result of a heightened immune response leading to organ damage and, in some cases, death. The TACTIC programme is designed to assess selected medications which modify the immune response. There are two trials in the programme: TACTIC-R is testing existing drugs (known as re-purposing) while TACTIC-E is looking at the use of new (experimental) treatments.

Quay Pharma is the only CDMO (Contract Development and Manufacturing Organisation) licensed globally for the support of oral drug product manufacture utilising microbial therapies. The company’s expertise in this area is based on its breadth of expertise in formulation development across many delivery routes, along with its understanding of isolation and containment techniques.

In particular, Quay has introduced procedures in order to effectively handle many types of microbes during the development and manufacture of drug products in order to maintain their potency.

EDP1815 is the first microbial biotherapeutic of its class to take part in this type of trial and Quay has worked closely with Evelo to rapidly bring the product to clinic. The progression to severe COVID-19 is associated with cytokine storm and hyperinflammation. Based on data from a Phase 1b clinical trial in psoriasis, EDP1815 has the potential to modulate multiple immune pathways associated with cytokine storm and resolve the inflammation without the risks associated with immunosuppression.  If approved for the treatment of COVID-19, Evelo could quickly scale up its manufacturing of EDP1815 to supply the drug at a reasonable cost.

Quay was the first UK company to be granted an MHRA licence to provide clinical trials materials for BSL Class II microbes to be administered in non-sterile forms to target the digestive, urogenital, otorhinologic and pulmonary pathways. The company’s expertise and GMP accredited state-of-the-art manufacturing facilities enable it to offer the development of crucial early stage clinical formulations and clinical manufacturing for First in Man (FIM) trials.

“We are extremely proud to be involved in this important project to help counter and reduce the effects of this terrible virus,” commented Quay Pharma CEO Maireadh Pedersen.

“The potential for microbes to treat a huge variety of gastrointestinal as well as many other disorders via the non-sterile delivery route is immense and we believe  our experience and extensive facilities make us the ideal partner to help bring new treatments rapidly and successfully to market.”

The EDP1815 project is one of several involving companies worldwide on which Quay is currently working to support the commercialisation of new therapeutics derived from the microbiome.