QIDP Drug Update – Part 1: An Updated Who Is Who

It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries.

(Status: 10/18/16)

Company	Drug Name	Antibiotic Class	Action Site	Phase in US	New Antibiotic Class?
Achaogen	Plazomicin	aminoglycoside	systemic	Phase 3	NO
Actelion Pharmaceuticals	Cadazolid	oxazolidinon/quinolone combo	GI only	Phase 3	YES
Allergan	Dalbavancin	glycopeptide	systemic	Approved US	NO
Allergan	Ceftazidime + avibactam	BL/BLI	systemic	Approved US	NO
Aradigm Pharmaceuticals	Ciprofloxacin	quinolone	pulmonary	Phase 3	NO
Basilea Pharmaceutica	Ceftobiprole	BL	systemic	Phase 3	NO
Basilea Pharmaceutica	isavuconazole	azole	systemic	Approved US	NO
Bayer	Amikacin Inhale	aminoglycoside	pulmonary	Phase 3	NO
Bayer	Ciprofloxacin DPI	quinolone	pulmonary	Phase 3	NO
Cardeas Pharma	Amikacin + fosfomycin	other combination	pulmonary	Phase 2	NO
Cellceutix Pharmaceuticals	Brilacidin	defensin-mimetic	systemic	Phase 2	YES
Cempra	Solithromycin	macrolide / ketolide	systemic	Phase 3	NO
Cempra	Fusidic Acid	fusidic acid	systemic	Phase 3	NO
Cidara	CD-101	echinocandin	systemic	Phase 1	NO
Citius	Mino-Lok	tetracycline	topical	Phase 2	NO
CorMedix	Neutrolin	other	topical	Phase 3	NO
Debiopharm	Debio-1450	Fabl inhibitor	systemic	Phase 2	YES
Destiny	XF-73	other	topical	Phase 2	YES
Entasis	ETX-0914	topoisomerase II-inhibitor	systemic	Phase 2	YES
GSK	GSK-2140944	topoisomerase II-inhibitor	systemic	Phase 2	YES
Innocoll	INL-002	aminoglycoside	topical	Phase 2	NO
Insmed	INS-212	aminoglycoside	pulmonary	Phase 3	NO
Ixodes	Ixogel	macrolide / ketolide	topical	Phase 2	NO
Matinas	MAT-2501	aminoglycoside	systemic	Pre-Clin	NO
Matinas	MAT-2203	polyene	systemic	Phase 2	NO
Meiji Seika	ME-1100	aminoglycoside	pulmonary	Phase 1	NO
Melinta	Delafloxacin	quinolone	systemic	Phase 3	NO
Merck	Ceftolozane + tazobactam	BL/BLI	systemic	Approved US	NO
Merck	Surotomycin	glycopeptide	GI only	Phase 3	NO
Merck	Tedizolid	oxazolidinone	systemic	Approved US	NO
Merck	Imipenem/cilastatin + MK-7655	BL/BLI	systemic	Phase 3	NO
MGB Biopharma	MGB-BP-3	other	topical	Phase 1	YES
Microbion	MBN-101	other	topical	Phase 1	NO
MorphoChem	MCB-3837	oxazolidinon/quinolone combo	systemic	Phase 1	YES
Motif Bio	Iclaprim	DHFR inhibitor / sulfonamide	systemic	Phase 3	NO
Nabriva	BC-3781	pleuromutilin	systemic	Phase 3	YES
Paratek	Omadacycline	tetracycline	systemic	Phase 3	NO
Polyphor	POL-7080	other	systemic	Phase 2	YES
Raptor	MP-376	quinolone	pulmonary	Phase 2	NO
RedHill	RHB-105	other combination	systemic	Phase 3	NO
Savara	AeroVanc	glycopeptide	pulmonary	Phase 2	NO
Scynexis	SCY-078	other	systemic	Phase 2	YES
Summit	SMT-19969	imidazole	GI only	Phase 2	NO
Symbiomix	SYM-1219	imidazole	systemic	Phase 3	NO
TaiGen	Nemonoxacin	quinolone	systemic	Phase 3	NO
Tetraphase	TP-271	tetracycline	systemic	Phase 1	NO
Tetraphase	Eravacycline	tetracycline	systemic	Phase 3	NO
The Medicines Company	Oritavancin	glycopeptide	systemic	Approved US	NO
The Medicines Company	Meropenem + RPX7009	BL/BLI	systemic	Phase 3	NO
Valley Fever Solutions	NikZ	other	systemic	Phase 1	YES
Viamet	VT-1129	azole	systemic	Phase 1	NO
Vical	VL-2397	other	systemic	Phase 1	YES
Wockhardt	WCK-5222	BL/BLI	systemic	Phase 1	NO
Wockhardt	WCK-4873	macrolide / ketolide	systemic	Phase 1	NO
Wockhardt	WCK-2349	quinolone	systemic	Phase 2	NO
Wockhardt	WCK-771	quinolone	systemic	Phase 2	NO
Zavante	ZTI-01	fosfomycin	systemic	Phase 2	NO

Despite best efforts to provide accurate information, errors may have crept in. Please let us know if you detect mistakes. We will make corrections or post an update based on your feedback. Supporting evidence would be appreciated.

Some information is notoriously hard to come by. Is a certain drug after months or a year of inactivity still in development? When a compound fails to show up on a company’s pipeline we assume it has died even if there is no ‘official’ announcements of its demise, keeping in mind that lack of development for prolonged periods of time is not all that unusual.

There are plenty of examples of ‘sleeper’ programs that suddenly became active again, for instance after a pause due to outlicensing efforts when new sponsors have to get up to speed. Clearly, such long hibernation phases make it difficult to distinguish death from suspended animation and from other causes as may exist.

Development “Phase” designation is a dynamic property in the quick-paced world of QIDP drugs. Progress is often – but not always – faster than in standard anti-infective drug development; phases can be compressed or even skipped entirely.

Companies sometimes refer to their asset as ‘Phase 2 ready’ or indicate that an SPA has been agreed to with FDA – a sure sign that Phase 3 could start any time. Hence, Phase assignments may be outdated quickly; the attached table is no more than a snapshot in time.

Further analyses about the “State of QIDP drugs” will be the topic of an upcoming blog.

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