Drug & Device Pipeline News

December 19, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Erasca	ERAS-3490	KRAS G12C-mutated solid tumors, including non-small cell lung cancer	IND approved by the FDA for a phase 1 trial
Vertex Pharmaceuticals	VX-522	Cystic fibrosis in patients with a CFTR genotype not responsive to CFTR modulator therapy	IND approved by the FDA for a phase 1 trial
AnHeart Therapeutics	Safusidenib	IDH1 mutant glioma	IND approved by the FDA for a phase 2 trial
NMD Pharma	NMD670	Spinal muscular atrophy type 3	IND approved by the FDA for a phase 2 trial
Recce Pharmaceuticals	RECCE 327	Diabetic foot infections	Approval from Australia’s regulatory authority for a phase 1/2 trial
Trials Initiated
Indaptus Therapeutics	INDP-D101	Advanced/metastatic solid tumors	Initiation of a phase 1 trial
Frequency Therapeutics	FX-345	Sensorineural hearing loss	Initiation of a phase 1b trial
Rigel Pharmaceuticals	R289	Treatment of patients with lower-risk myelodysplastic syndromes who are refractory/resistant to prior therapies	Initiation of a phase 1b trial
Small Pharma	SPL026	Major depressive disorder	Initiation of a phase 1b trial in the UK
Dermaliq Therapeutics	DLQ01	Androgenic alopecia	Initiation of a phase 1b/2a trial
SpliSense	SPL84	Cystic fibrosis in patients carrying the 3849+10 Kb C->T mutation in the CFTR gene	Initiation of a phase 1/2 trial
SwanBio Therapeutics	SBT101	Adrenomyeloneuropathy	Initiation of a phase 1/2 trial
Asieris Pharmaceuticals	APL-1202 in combination with tislelizumab	Muscular invasive bladder cancer	Initiation of phase 2 portion of a phase 1/2 trial
Actinogen Medical	Xanamem	Major depressive disorder and cognitive impairment	Initiation of a phase 2 trial
Cardiol Therapeutics	CardiolRx	Recurrent pericarditis	Initiation of a phase 2 trial
MoonLake Immunotherapeutics	Sonelokimab	Active psoriatic arthritis	Initiation of a phase 2 trial
Rezolute	RZ402	Diabetic macular edema	Initiation of a phase 2 trial
Chimerix	ONC201	Recurrent H3 K27M-mutant diffuse glioma	Initiation of a phase 3 trial
Approvals
Pfizer BioNTech	Omicron BA.4/BA.5-adapted bivalent	COVID-19 vaccine	Emergency Use Authorization granted by the FDA for use in children under age five years
Mirati Therapeutics	Krazati (adagrasib)	KRASG12C-mutated non-small cell lung cancer	Approved by the FDA
Mirum Pharmaceuticals	Livmarli (maralixibat)	Cholestatic pruritus in patients with Alagille syndrome age two months and older	Approved by the European Commission
Regeneron Sanofi	Dupixent (dupilumab)	Prurigo nodularis	Approved by the European Commission