Target product profile for pandemic preparedness

Pandemic preparedness

Target product profile for pandemic preparedness

Target product profile for mild/moderate outpatient COVID-19

The ANTICOV consortium, led by DNDi, aims to identify treatments suitable for outpatient delivery to prevent the progression of mild or moderate COVID-19 to severe disease and spikes in hospitalizations that could overwhelm overburdened health systems in low-resource settings.

	Ideal	Acceptable
Indication	For treatment of non-severe and uncomplicated, symptomatic COVID-19 disease and clear the virus This will not address potential other use for asymptomatic or contacts (this would require another TPP)	For treatment of non-severe and uncomplicated, symptomatic COVID-19 disease (with the intent to prevent progression to severe disease) Complicated cases to be defined in an Appendix based on agreed criteria (WHO/ACT-A, ANTICOV Consortium)
Target population(s)	Adults, pregnant and breastfeeding women, and children who are > 6 years Can be treated as outpatients Can be used in HIV+ patients (provided no DDI)	Adults Can be treated as outpatients
Target countries	Global	Global
Expected efficacy/ endpoints	Primary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment Secondary: improvement of pre-existing symptoms Direct antiviral efficacy measured as a proportion of patients with negative respiratory swab on Day 7 after treatment initiation measured by RT-PCR	Primary: decrease progression of disease vs SoC by 50% measured as SpO2 ≤ 93% at end of treatment Secondary: improvement of pre-existing symptoms
Safety	No need for laboratory or ECG monitoring (including for treatment initiation)	No need for systematic follow-up laboratory or ECG monitoring Clinical benefit outweighs risks during active infection and transmission – SAEs are no higher than for SoC
Coadministration	Combination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators).	Combination with other COVID-19 interventional agents not contraindicated (antibiotics, immunomodulators)
Contraindications, warnings, precautions, interactions, and use during pregnancy and lactation	Could be co-administered in TB, HIV and malaria co-infected patients (no DDI with rifampicin) Efficacy and safety in malnourished patients Could be administered with antidiabetics, anti-hypertensive treatments	Cannot be administered in loa-loa patients (specific to ivermectin)
Route of administration	Multiple formulations – oral and pediatric formulations	Oral tablet or capsule preferred Sub-cutaneous or depot IM only if single dose treatment
Dosage form and schedule	Once a day ≤ one week (including for children, adolescents)	Up to 3x per day (oral) if limited to 3 days max 2x per day – up to 2 weeks max
Shelf-life	Finished product stable for 5 years	Finished product stable for 2 years
Cost	Under 5 USD/regimen	Under 10 USD/regimen
Storage	Store at room temperature (defined as 30 °C/75 % RH (zone IV B conditions)	Store at room temperature (defined as 30 °C/75 % RH (zone IV B conditions)
Product registration path	Label extension via AMA – WHO-PQ	Label extension via AMA – WHO-PQ

Abbreviations: ACT-A : Advancing Cryptococcal Meningitis Treatment for Africa; AMA: American Medical Association; ASAQ: Artesunate + amodiaquine; DDI : drug-drug interactions; ECG: electrocardiogram; IM: intramuscular; PQ: Prequalification; RH: relative humidity; SAE: severe adverse effect; SoC : standard of care; SpO2 : peripheral capillary oxygen saturation; TB: tuberculosis; TPP: Target Product Profile; WHO: World Health Organization.

Making medical history for neglected patients

We develop urgently needed treatments for neglected patients and ensure they’re affordable, available, and adapted to the communities who need them

Young boy sitting on a hospital bed being examined by a nurse

Chagas disease

Causes heart and vital organ damage, after people are bitten by blood-sucking bugs

We delivered the first-ever treatment for children; now we’re searching for new drug candidates and working to boost access to care

Cryptococcal meningitis

Without treatment, deadly for thousands of people with advanced HIV

We’re working to improve access to life-saving treatments and developing an easier-to-use formulation

Cutaneous leishmaniasis

Leaves disfiguring, life-long scars that lead to severe social stigma

We’re working to develop safer, shorter treatments for this disabling disease

Doctor with young patient in hospital setting

Dengue

Rapidly spreading climate-sensitive disease with no specific treatment

We’re building a global partnership with dengue-endemic countries to develop a first treatment

Father walking in rural village with a cane and holding his son's hand

Filaria: river blindness

Lead to unbearable itching, disfiguring skin lesions, and even blindness

We’re working to develop a safe, effective, and affordable drug for the prevention and treatment of this debilitating disease

Hepatitis C

Millions are left without treatment even though effective drugs exist

We’ve delivered a treatment as simple, safe, and effective as the best drugs available today – at a fraction of the cost

Woman standing in front of her door house in a rural village in Sudan

Mycetoma

Often ends in amputation, after people get infected from stepping on a thorn

We conducted the world’s first trial for an alternative to current treatments, which are toxic and difficult to administer

Mother holding her baby in her arms smiling

Paediatric HIV

Without treatment, half of children die before their second birthday

We’ve developed a strawberry-flavoured treatment to meet the needs of children long neglected by the global HIV response