Drug & Device Pipeline News

January 17, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aramis Biosciences	A197	Dry eye disease	IND approved by the FDA
atai Life Sciences	PCN-101 (R-ketamine)	Treatment-resistant depression	IND approved by the FDA
Black Diamond Therapeutics	BDTX-1535	Glioblastoma multiforme and nonsmall-cell lung cancer	IND approved by the FDA
Peptilogics	PLG0206	Periprosthetic joint infection	IND approved by the FDA
Evolved by Nature	Activated Silk Dermal Filler	Moderate-to-severe facial wrinkles and folds	Investigational Device Exemption granted by the FDA
Reviva Pharmaceuticals	Brilaroxazine	Schizophrenia	Study May Proceed letter issued by the FDA
Laekna Therapeutics Innovent	Afuresertib (LAE002), sintilimab and chemotherapy	Solid tumors refractory to treatment with PD-1/PD-L1 inhibitors	IND approved by China’s regulatory authority
Starton Therapeutics	STAR-LLD	Multiple myeloma and chronic lymphocytic leukemia	Clinical trial authorized by the Netherland’s regulatory authority
Biomica	BMC-128 plus Opdivo	Lung cancer, melanoma or renal cell carcinoma	Approval for a phase 1 trial granted by Israel’s regulatory authority
InFlectis BioScience	IFB-088	Amyotrophic lateral sclerosis	Approval for a phase 2 trial granted by France’s regulatory authority
Trials Initiated
Cyteir Therapeutics	CYT-0851	Hematologic malignancies and solid tumors	Initiation of phase 1 trial
Dynavax	CpG 1018 adjuvant vaccine	Shingles	Initiation of phase 1 trial
Viking Therapeutics	VK2735	Metabolic disorders	Initiation of phase 1 trial
HutchMed	HMPL-760	Hematological malignancies	Initiation of phase 1 trial in China
4D Molecular Therapeutics	4D-150	Neovascular age-related macular degeneration	Initiation of phase 1/2 trial
Adagene	ADG106 plus nivolumab	Advanced nonsmall-cell lung cancer in patients who have progressed on prior therapy	Initiation of phase 1b/2 trial in Singapore
Nuvalent	NVL-520	Advanced solid tumors	Initiation of phase 1/2 trial
Rubius Therapeutics	RTX-224	Certain relapsed/refractory or locally advanced solid tumors	Initiation of phase 1/2 trial
Theseus Pharmaceuticals	THE-630	Advanced gastrointestinal stromal tumors	Initiation of phase 1/2 trial
SciSparc	SCI-110	Alzheimer's disease and agitation	Initiation of phase 2a trial in Israel
Ascletis	ASC42	Chronic hepatitis B	Initiation of phase 2 trial
Ascletis	ASC40	Moderate-to-severe acne	Initiation of phase 2 trial
Glaukos	GLK-302	Presbyopia	Initiation of phase 2 trial
I-Mab	Efineptakin alfa plus Keytruda	Advanced solid tumors	Initiation of phase 2 trial in China
Rhythm Pharmaceuticals	Setmelanotide	Severe obesity and hyperphagia potentially caused by predefined genetic variants	Initiation of phase 2 trial
IMV	Maveropepimut-S in combination with Keytruda	Relapsed/refractory diffuse large B-cell lymphoma	Initiation of phase 2b trial
Gritstone bio	Granite neoantigen vaccine	Maintenance treatment for newly metastatic, microsatellite-stable colorectal cancer	Initiation of phase 2/3 trial
Arrowhead Pharmaceuticals	ARO-APOC3	Familial chylomicronemia syndrome in adults	Initiation of phase 3 trial
Rhythm Pharmaceuticals	Setmelanotide weekly formulation	Obesity due to predefined genetic variants or Bardet-Biedl syndrome with genetic confirmation enrolled in a previous study	Initiation of phase 3 trial
SK Life Sciences	Carisbamat	Seizures associated with Lennox-Gastaut syndrome	Initiation of phase 3 trial
Approvals
Idorsia	Quviviq (daridorexant)	Insomnia	Approved by the FDA
Otsuka H. Lundbeck	Rexulti (brexpiprazole)	Schizophrenia in pediatric patients 13 to 17 years of age	Approved by the FDA for expanded indication
Cochlear Limited	Cochlear nucleus implants	Unilateral hearing loss/single-sided deafness	Approved by the FDA for expanded indication