Drug & Device Pipeline News

October 9, 2023

This week’s Pipeline features a phase 2 trial approval for bipolar disorder, a phase 3 trial initiation for advanced metastatic breast cancer, and an FDA drug approval for major depressive disorder.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Antibe Therapeutics	Otenaproxesul	Acute pain	IND for a phase 1 trial approved by Health Canada
Cabaletta Bio	CABA-201	Systemic sclerosis	IND for a phase 1/2 trial approved by the FDA
Akeso	AK117	Newly diagnosed higher-risk myelodysplastic syndromes	IND for a phase 2 trial approved by the FDA
MAIA Biotechnology	THIO	Advanced non-small cell lung cancer	IND for a phase 2 trial approved by the FDA
Alzamend Neuro	AL001	Bipolar disorder	IND for a phase 2 trial approved by the FDA
Transcenta	Osemitamab	First-line gastric/gastroesophageal cancer	IND for a phase 3 trial approved by the FDA
ReGelTec	HYDRAFIL System	Chronic low back pain due to degenerative disc disease	IDE approved by the FDA
Trials Initiated
Gain Therapeutics	GT-02287	Parkinson’s disease	Initiation of a phase 1 trial
HanchorBio	HCB101	Advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma	Initiation of a phase 1 trial
ImmunoGenesis	IMGS-001	Relapsed/refractory advanced solid tumors	Initiation of a phase 1a/1b trial
Synthekine	STK-012	Solid tumors including renal cell carcinoma and non-small cell lung cancer	Initiation of phase 1b portion of phase 1a/1b trial
Starton Therapeutics	STAR-LLD (low-dose lenalidomide)	Multiple myeloma	Initiation of a phase 1b trial
Clarity Pharmaceuticals	64Cu/67Cu SAR-Bombesin	Metastatic castration-resistant prostate cancer	Initiation of a phase 1/2 trial
Moleculin Biotech	Annamycin plus cytarabine	Acute myeloid leukemia	Initiation of phase 2 portion of phase 1b/2 trial
Mabwell	9MW2821 plus PD-1 inhibitor	Locally advanced or metastatic urothelial carcinoma	Initiation of a phase 1b/2 trial in Europe
Vedanta Biosciences	VE202	Ulcerative colitis	Initiation of a phase 2 trial
Agomab Therapeutics	AGMB-129	Fibrostenosing Crohn’s disease	Initiation of a phase 2a trial
Boehringer Ingelheim Zealand Pharma	Survodutide	Obese or overweight people with comorbidities but not type 2 diabetes	Initiation of a phase 3 trial
Boehringer Ingelheim Zealand Pharma	Survodutide	Obese or overweight people with comorbidities including type 2 diabetes	Initiation of a phase 3 trial
Boehringer Ingelheim Zealand Pharma	Survodutide	Obese or overweight people with cardiovascular disease or chronic kidney disease	Initiation of a phase 3 trial
BriaCell Therapeutics	Bria-IMT plus an immune checkpoint inhibitor	Advanced metastatic breast cancer	Initiation of a phase 3 trial
Approvals
Amicus Therapeutics	Pombiliti (cipaglucosidase alfa-atga) plus Opfolda (miglustat)	Late-onset Pompe disease	Approved by the FDA
Fabre-Kramer Pharmaceuticals	Exxua (gepirone hydrochloride extended-release tablets)	Major depressive disorder in adults	Approved by the FDA
Novo Nordisk	Rivfloza (nedosiran) injection	Patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function	Approved by the FDA
Apellis Pharmaceuticals	Empaveli (pegcetacoplan) Injector	Paroxysmal nocturnal hemoglobinuria	Approved by the FDA