Pipeline Watch: Phase III Progress With Roche's Baloxavir, Pfizer's Tanezumab And Takeda's Vedolizumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The progression of investigational products through a series of increasingly sophisticated and targeted clinical trials is a well-tried and tested route for the development of new medicines for commercialization. Knowing the stage that an investigational medicine has reached is information of great interest to competing companies, regulators, patients and payers.

The table below records the past week’s changes to the progress of selected potential new products through the clinical trial pipeline, using data from Informa Pharma Intelligence’s Biomedtracker. It lists drugs for which an important event was recorded between Jul. 13 and Jul. 19, 2018, divided by event type.

Events can include Phase II and Phase III trial initiations, development discontinuations, and the release of top-line and updated clinical trial results. A brief summary of product approvals is also included.

A companion resource, the Pink Sheet’s regulatory-focused FDA Performance Tracker, follows regulatory milestones such as submissions, user fee dates, complete response letters and approvals.

Pipeline Watch – Jul. 13 to Jul. 19, 2018

Lead company/partner	Compound	Indication	Comments
PHASE III SUSPENDED
Novartis AG	LIK066	obesity	The LIK066 for weight loss project has been discontinued after Phase II data.
PHASE III RESULTS PUBLISHED
AstraZeneca PLC	Lynparza (olaparib)	ovarian cancer	SOLO-2 study - The Lancet Oncology on July 16.
Emmaus Medical, Inc.	Endari (L-glutamine oral powder)	sickle cell anemia	New England Journal of Medicine.
Tesaro Inc../Johnson & Johnson	Zejula (niraparib)	ovarian cancer	ENGOT-OV16/NOVA in The Lancet Oncology in July 2018.
PHASE III INTERIM/TOP-LINE RESULTS
Roche/ Genentech Inc.	Tecentriq (atezolizumab)	non-small cell lung cancer (NSCLC)	IMpower 132 study in advanced non-squamous NSCLC positive.
Shanghai Green Valley Pharmaceutical Co. Ltd	sodium oligomannurarate (GV-971)	Alzheimer's disease	Phase III trial met its primary endpoint.
Beijing Northland Biotech. Co., Ltd.	NL-201	thrombocytopenia	Positive Phase III data. Phase IIIb study being prepared.
Roche/ Shionogi & Co. Ltd.	baloxavir marboxil (S-033188)	influenza (excluding vaccines)	CAPSTONE-2 study – primary endpoint achieved.
Johnson & Johnson	Invokana (canagliflozin)	diabetic nephropathy	CREDENCE study - renal outcomes trial stopped early based on the achievement of pre-specified efficacy criteria.
Takeda Pharmaceutical Co. Ltd.	vedolizumab sc	ulcerative colitis	VISIBLE 1 study – primary endpoint achieved.
Allergan PLC	Abicipar Pegol	wet age-related macular degeneration	SEQUOIA and CEDAR met the pre-specified primary endpoint.
Novartis AG	osilodrostat	Cushing's syndrome	LINC-3 study met the primary endpoint.
Pfizer Inc./ Eli Lilly & Co.	tanezumab	osteoarthritis	Phase III study (A4091056) met all three co-primary endpoints.
UPDATED PHASE III RESULTS
CytoDyn Inc.	PRO 140	HIV / AIDS	PRO 140 HIV combination trial - positive completed results.
PHASE II INTERIM/TOP-LINE RESULTS
Cellectar Biosciences Inc.	CLR 131	hematologic cancer	Positive interim data in diffuse large B-cell lymphoma.
Catalyst Biosciences Inc.	marzeptacog alfa	hemophilia A and B	Interim results from the Phase II/III trial support the target of achieving significant reductions in annualized bleed rate.
Biotest AG	BT-063	systemic lupus erythematosus	Study No. 990 Phase IIa study achieved its primary endpoint.
UPDATED PHASE II RESULTS
ThromboGenics NV	THR-317	diabetic macular edema	THR-317-001 study data provide continued support to the development.
Asterias Biotherapeutics Inc.	AST-OPC1	spinal cord injury	Additional positive data from the ongoing Phase I/IIa SCiStar study.
Catalyst Biosciences Inc.	CB-FIX	hemophilia B	Positive data from the CB 2679d/ISU304 Phase I/II trial.

Source: Informa Pharma Intelligence’s Biomedtracker.

Marketing Approvals – Jul. 13 to Jul. 19, 2018

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Amgen Inc.	Novartis	Aimovig (erenumab)	migraine	Switzerland	On Jul. 13.
Medical Developments International Ltd.	-	Penthrox (methoxyflurane)	pain indications	Spain	-
Siga Technologies Inc.	-	Tpoxx (tecovirimat)	smallpox	US	Available initially only through the US government’s Strategic National Stockpile.
Sun Pharmaceutical Industries Ltd.	-	Infugem (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL	NSCLC/ breast cancer/ ovarian cancer/ pancreatic cancer	US	In a ready-to-administer bag.
Johnson & Johnson	Gilead Sciences Inc.	Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg)	HIV / AIDS	US	In treatment-naïve and certain virologically suppressed adults.
SUPPLEMENTAL REGULATORY APPROVAL
Astellas Pharma Inc.	Pfizer Inc.	Xtandi (enzalutamide)	prostate cancer	US	Now including men with non-metastatic CRPC.
Novartis AG	-	Kisqali (ribociclib)	breast cancer	US	In combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

Source: Biomedtracker.

Data are from Biomedtracker, the pharmaceutical and biotechnology industries’ window into the FDA approval process, offering real-time intelligence for clinical and regulatory events. For more information on the research covered in this article, click here.