Drug & Device Pipeline News

May 1, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Invivyd	VYD222	Prevention of COVID-19 in vulnerable people	IND for a phase 1 trial approved by the FDA
Bridge Biotherapeutics	BBT-207	Non-small cell lung cancer with EGFR mutations	IND for a phase 1/2 trial approved by the FDA
Direct Biologics	ExoFlo	Medically refractory perianal fistulizing Crohn’s disease	IND for a phase 1/2 trial approved by the FDA
Stoke Therapeutics	STK-002	Autosomal dominant optic atrophy	IND for a phase 1/2 trial approved by the UK’s regulatory authority
Trials Initiated
Avacta	AVA6000	Locally advanced or metastatic solid tumors	Initiation of a phase 1 trial
Janux Therapeutics	JANX008	Advanced or metastatic solid tumors	Initiation of a phase 1 trial
Oblato	OKN-007	Recurrent high-grade glioma	Initiation of a phase 1 trial
AbbVie Calico Life Sciences	ABBV-CLS-7262	Vanishing white matter disease	Initiation of a phase 1b trial
Elicio Therapeutics	ELI-002 7P	KRAS/NRAS mutated solid tumors	Initiation of a phase 1/2 trial
Contrafect	Exebacase	Chronic prosthetic joint infections of the knee	Initiation of a phase 1b/2 trial
Artelo Biosciences	ART27.13	Cancer-related anorexia and weight loss	Initiation of a phase 2a trial
Aphaia Pharma	APH-012	Prediabetes	Initiation of a phase 2 trial
CinRx Pharma	Deudomperidone	Diabetic gastroparesis	Initiation of a phase 2 trial
Okyo Pharma	OK-101 ophthalmic solution	Dry eye disease	Initiation of a phase 2 trial
Sunovion Pharmaceuticals Otsuka Pharmaceutical	Ulotaront	Generalized anxiety disorder	Initiation of a phase 2/3 trial
Galapagos	Filgotinib	Active radiographic and nonradiographic axial spondyloarthritis	Initiation of two phase 3 trials
I-Mab Biopharma	Lemzoparlimab plus azacitidine	Higher-risk myelodysplastic syndrome	Initiation of a phase 3 trial in China
Approvals
Biogen Ionis	Qalsody (tofersen)	SOD1-amyotrophic lateral sclerosis	Accelerated approval granted by the FDA
Galderma	Sculptra (injectable poly-L-lactic acid)	Cheek wrinkles	Approved by the FDA
Seres Therapeutics Nestlé Health Science	Vowst (fecal microbiota spores, live-brpk)	Recurrent C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI	Approved by the FDA
Vertex Pharmaceuticals	Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor)	Treatment of children with cystic fibrosis age two through five years with certain mutations	Approved by the FDA for expanded age indication