Gonorrhoea is an urgent and growing public health problem
The World Health Organization (‘WHO’) estimates there are approximately 78 million new cases of gonorrhoea globally per year. Neisseria gonorrhoeae has consistently developed resistance to each class of antibiotics recommended for treatment. There is now only one treatment recommended by the US Centers for Disease Control and Prevention (‘CDC’).
Cases per year in US & EU & 78m worldwide
N. Gonorrhoeae has consistently developed resistance to known classes of antibiotic
Using last CDC recommended treatment option; no new treatment options available
This is a combination of two antibiotics, and its use is approaching a rate of resistance at which we believe it will no longer be recommended for treatment. There are currently no other CDC recommended antibiotics that can be effectively deployed to target the disease. The WHO ranks R&D investment into the search for antibiotics which are effective against N. gonorrhoeae as high priority. N. gonorrhoeae is also identified as one of three urgent threats by CDC requiring aggressive action.
Using our Discuva Platform, we have identified two novel targets to kill the N. gonorrhoeae bacteria and discovered a new series of antibiotic compounds against each of these targets. In early testing, these two-distinct series of antibiotics have been shown to have high potency against gonorrhoea, including drug resistant strains.
Our lead candidate from the first programme is SMT-571. SMT-571 has shown in vivo preclinical activity and oral bioavailability. We expect to initiate a Phase 1 clinical trial of SMT-571 in the second half of 2019.
In 2018, we were awarded up to $4.5 million from CARB-X, a public-private partnership devoted to accelerating early antibiotic research and development. The funding is supporting the development of SMT-571 through preclinical studies and a Phase 1 clinical trial.
With only one currently recommended treatment option for gonorrhoea, we believe both series of antibiotics have the potential to meaningfully contribute to the fight against the disease. Our goal is to be adopted onto the WHO guidelines, which are widely accepted and followed by healthcare providers when treating gonorrhoea. To do so, we need to show that our compounds fit the needs of patients and healthcare providers: that the antibiotics are new mechanisms, oral, narrow spectrum and target the three sites of gonorrhoea infection (throat, genitals and rectum).
With 1.4 million cases in the US and Europe and 78 million worldwide and rising resistance to existing treatments, gonorrhoea is a major problem. We believe there is value in developing new mechanism antibiotics to become the new standard of care for the treatment of gonorrhoea.