The spread and incidence of gonococcal antimicrobial resistance (AMR) is rapidly outpacing the development of new medicines. Without action, untreatable gonorrhoea will soon become a reality, bringing with it a host of clinical manifestations and complications (increased risk of HIV infection, pelvic inflammatory disease, ectopic pregnancies, infertility, neonatal conjunctivitis and blindness).

Gonorrhoea is a community-acquired infection and patients are treated within their localities based on symptoms experienced, as diagnostic capabilities in such settings are limited. Antibiotics are chosen based on early recognizable signs and which ones will handle the most organisms and the essential ones responsible for the disease. Knowing this, it is critical that the broader public health framework of STI management be considered when defining R&D priorities and activities.

With the support of gonorrhoea experts the world over, GARDP has devised short- and long-term Target Product Profiles (TPPs) to guide the development of an R&D strategy for STIs. The goal of this strategy is to deliver, within seven years, at least one treatment that:

  • works against drug-sensitive and drug-resistant gonorrhoea
  • is suitable for integration into international and national STI treatment guidelines
  • can address both uro-genital and extra-genital infections.

As no current programmes target all three of the above criteria, GARDP will fill this gap to by partnering with key stakeholders involved in tackling drug resistant gonococcal infections to develop reliable and sustainable treatment options for the post-cephalosporin era.

 

Components of GARDP’s R&D strategy for STIs include:

  1. Accelerating the development of an NCE for the treatment of gonorrhoea;
  2. Evaluating the utility of existing antibiotics and their combinations for the treatment of STIs;
  3. Exploring co-packaging of optimal combinations and development of fixed-dose combinations (FDCs); and
  4. Supporting the development of simplified treatment guidelines for the empiric management of STIs.

 A far-reaching first approach

By 2023, GARDP aims to register a new drug for gonorrhoea in a number of high burden countries, ensure its integration into relevant policies and guidelines, and initiate its implementation together with a suitable treatment conservation and access strategy.

 

 

More information:

Read the programme strategy

Read a snapshot of the programme  English Deutsch

 

  Ideal

Acceptable

Indication

First line treatment of uncomplicated, uro-genital gonorrhoea (sensitive and MDR)

First line treatment of extra-genital gonorrhoea (ano-rectal and oro-pharyngeal)

First line treatment of uncomplicated, uro-genital gonorrhoea (sensitive and MDR)

Activity against co-infecting STI pathogens

Chlamydia trachomatis  

Patient population

Adults and adolescents Adults and adolescents

Clinical efficacy

97% (95% CI, 95-100) 95% (95% CI, 90-100)

Activity against ESC and macrolide-resistant NG strains

Yes

Yes

Mechanism of action (target site, -cidal vs static; broad-spectrum vs narrow spectrum)

Bactericidal/static

Intracellular activity

No cross resistance

Bactericidal/static

Limited cross-resistance

Safety and tolerability

Safe in pregnancy and lactation

No patient monitoring required post treatment

Minimal outpatient monitoring required post treatment

Contraindications

None Pregnancy and lactation

Drug-drug interaction profile

None Minimal

Route of administration / formulation

Oral/IM, loose combination  

Dosing schedule

Single dose Multiple doses

Treatment duration

One day Up to 5 days

Stability

Heat stable, 3-year shelf-life in region 4 Heat-stable, 3-year shelf life

Cost (price /day of therapy)

Equivalent to current treatment regimens Oral/IM, loose combination

Time to patient availability

5 years 7 years
  Ideal Acceptable

Indication

First line treatment of uro-genital gonorrhoea (sensitive and MDR, complicated and uncomplicated)

First line treatment of extra-genital gonorrhoea (ano-rectal and oro-pharyngeal)

Treatment of chlamydia infections

First line treatment of uro-genital gonorrhoea (sensitive and MDR)

First line treatment of extra-genital gonorrhoea (ano-rectal and oro-pharyngeal)

Treatment of chlamydia infections

Activity against co-infecting STI pathogens

Chlamydia trachomatis, Mycoplasma genitalium Chlamydia trachomatis

Patient population

Adults, children and adolescents Adults, children and adolescents

Clinical efficacy

97% (95% CI, 95-100) 95% (95% CI, 90-100)

Activity against ESC and macrolide-resistant NG strains

Yes

Yes

Mechanism of action (target site, -cidal vs static; broad-spectrum vs narrow spectrum)

Unique mechanism

Bactericidal/static

Intracellular activity

No cross resistance

 

Bactericidal/static

Limited cross-resistance

Safety and tolerability

Safe in pregnancy and lactation

No patient monitoring required post treatment

Minimal outpatient monitoring required post treatment

Contraindications

None Pregnancy and lactation

Drug-drug interaction profile

None Minimal

Route of administration / formulation

Fixed-dose combination (FDC)  Co-packaged loose combination

Dosing schedule

Single dose Multiple doses

Treatment duration

Up to 3 days Up to 5 days

Stability

Heat stable, 3-year shelf-life in region 4 Heat-stable, 3-year shelf life

Cost (price /day of therapy)

Equivalent to current treatment regimens  

Time to patient availability

7 years 10 years

 

July 2017 Update