Drug & Device Pipeline News

October 10, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Clarametyx Biosciences	CMTX-101	Community-acquired bacterial pneumonia	IND approved by the FDA
Immuneering	IMM-1-104	RAS mutant solid tumors	IND approved by the FDA
Kezar Life Sciences	Zetomipzomib	Autoimmune hepatitis	IND approved by the FDA
Prometheus Biosciences	PRA052	Ulcerative colitis	IND approved by the FDA
Seneca Therapeutics	SVV-001	TEM8-positive and SVV-001-permissive endocrine tumors or neuroendocrine carcinomas	IND approved by the FDA
Transcenta	TST004	IgA nephropathy	IND approved by the FDA
Napo Pharmaceuticals	NP-300	Diarrhea from bacterial, viral and parasitic infections, including Vibrio cholerae	IND approved by the FDA
Kira Pharmaceuticals	KP104	Systemic lupus erythematosus-associated thrombotic microangiopathy	IND approved by the FDA for phase 2 trial
Trials Initiated
Icosavax	IVX-A12	Respiratory syncytial virus and human metapneumovirus	Initiation of phase 1 trial
Mind Medicine	R-MDMA, S-MDMA and MDMA	Psychiatric conditions	Initiation of phase 1 trial in Switzerland
Kling Biotherapeutics	KBA1412	Advanced solid tumors	Initiation of phase 1b trial
Abcuro	ABC008	T-cell large granular lymphocytic leukemia	Initiation of phase 1/2 trial
Mustang Bio	MB-106	B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia	Initiation of phase 1/2 trial
NextCure	NC410 in combination with Keytruda (pembrolizumab)	Immune checkpoint refractory or naïve solid tumors	Initiation of phase 1b/2 trial
Ascletis Pharma	ASC41	Non-alcoholic steatohepatitis	Initiation of phase 2 trial
New Amsterdam	Obicetrapib	Dyslipidemia	Initiation of phase 2 trial in Japan
Cyclo Therapeutics	Trappsol Cyclo	Early Alzheimer’s disease	Initiation of phase 2b trial
Enanta Pharmaceuticals	EDP-938	RSV infection in high-risk adults	Initiation of phase 2b trial
Monopar Therapeutics	Validive	Prevention of severe oral mucositis in patients undergoing chemoradiotherapy for oropharyngeal cancer	Initiation of phase 3 portion of phase 2/3 trial
Biogen Denali Therapeutics	BIIB122 (DNL151)	Parkinson’s disease with LRRK2 genetic mutation	Initiation of phase 3 trial
Approvals
Amylyx Pharmaceuticals	Relyvrio (sodium phenylbutyrate and taurursodiol)	Amyotrophic lateral sclerosis	Approved by the FDA
Fennec Pharmaceuticals	Pedmark (sodium thiosulfate injection)	Hearing loss associated with cisplatin in pediatric patients one month of age and older with localized, nonmetastatic solid tumors	Approved by the FDA
Taiho Pharmaceutical	Lytgobi (futibatinib)	Previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma	Approved by the FDA
Bayer	Nubeqa (darolutamide) in combination with docetaxel	Metastatic castration-sensitive prostate cancer	Approved in Canada for new indication