Pipeline Watch: Phase III Readouts For Guselkumab, Volanesorsen And Dupilumab

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 more 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 March 3 and March 9, 2017, 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 filings of marketing applications, orphan drug designations, submissions, complete response letters and launches.

Pipeline Watch – March 3 to March 9, 2017

Source: Informa Pharma Intelligence’s BiomedTracker.

Lead company/partner	Compound	Indication	Comments
Phase III Results Published
Array BioPharma Inc. /Pierre Fabre Group	binimetinib	NRAS-mutant melanoma	NEMO; in The Lancet Oncology, March 8, 2017.
OncoGenex Pharmaceuticals Inc.	custirsen	prostate cancer	SYNERGY; The Lancet Oncology, March 7, 2017
Updated Phase III Results
Eli Lilly & Co.	Taltz (ixekizumab)	plaque psoriasis	UNCOVER 3; maintained efficacy over two years.
Eli Lilly & Co.	Taltz (ixekizumab)	plaque psoriasis	IXORA-S; better than Stelara on response rates .
Sun Pharmaceutical Industries Ltd.	tildrakizumab	plaque psoriasis	reSURFACE 1; maintained to week 64.
Sanofi/Regeneron Pharmaceuticals Inc.	Dupixent (dupilumab)	atopic dermatitis	CHRONOS; further data on efficacy .
Amgen Inc.	Kyprolis (carfilzomib)	multiple myeloma	ENDEAVOR, ASPIRE, CLARION; effective and well tolerated.
UCB Group/Dermira Inc.	Cimzia (certolizumab pegol)	psoriasis; psoriatic arthritis	CIMPASI-1, -2; RAPID PSA; further positive data .
Amgen Inc.	Xgeva (denosumab)	multiple myeloma, skeletal-related events	Non-inferior to zoledronic acid.
Phase III Completed
TiGenix NV	Cx601	perianal fistula in Crohn’s disease	ADMIRE-CD; effective and well tolerated.
Phase III Interim/Top-line Results
Janssen R&D LLC /MorphoSys AG	guselkumab	plaque psoriasis	VOYAGE 2; NAVIGATE; improved skin clearance .
Aimmune Therapeutics Inc.	AR101	peanut allergy	PALISADE; screening data collected for the study.
GlaxoSmithKline PLC	Nucala (mepolizumab)	severe eosinophilic asthma	MUSCA; improved quality of life and lung function.
Ionis Pharmaceuticals Inc.	volanesorsen	familial chylomicronemia syndrome	APPROACH; met primary endpoint, reduced triglycerides .
Sanofi/Regeneron Pharmaceuticals Inc.	Dupixent (dupilumab)	atopic dermatitis	LIBERTY AD Open-Label; sustained efficacy.
TG Therapeutics Inc.	ublituximab	chronic lymphocytic leukemia	GENUINE; met primary endpoint, increased overall response rate.
Sandoz Pharma Ltd.	adalimumab, biosimilar	psoriasis	ADACCESS; equivalent efficacy and safety to Humira.
Hutchison China MediTech Ltd.	fruquintinib	colorectal cancer	FRESCO; positive results .
Phase III Initiated
Daiichi Sankyo Co. Ltd.	Savaysa (edoxaban)	stroke prevention	The ENTRUST-AF PCI study.
ObsEva SA	nolasiban (OBE001)	reproductive disorders	To improve live birth rates in embryo transplant procedures.
AB Science	mastinib	uncontrolled asthma	Uncontrolled by steroids.
Phase III Announced
Gilead Sciences Inc.	Epclusa (sofosbuvir/velpatasvir)	hepatitis C	Expected to enrol 125 patients.
Roche/MorphoSys AG	gantenerumab	Alzheimer’s disease	In prodromal to mild disease .
ObsEva SA	OBE2109	uterine fibroids	PRIMROSE-1.
Updated Phase II Results
Ocera Therapeutics Inc.	OCR-002	hepatic encephalopathy	STOP-HE; more encouraging results.
Aimmune Therapeutics Inc.	AR101	peanut allergy	95% adherence to daily at-home dosing.
DBV Technologies SA	Viaskin Peanut (transdermal allergen)	peanut allergy	OLFUS-VIPES; effect sustained over three years in children.
Viamet Pharmaceuticals Holdings LLC	VT-1161	onychomycosis	RENOVATE; durable responses, favourable safety.
Dermira Inc.	olumacostat glasaretil	acne	Early and sustained efficacy.
Dermira Inc.	glycopyrronium tosylate (DRM04)	axillary hyperhidrosis	Topical agent producing sustained clinical effects
Revance Therapeutics Inc.	daxibotuliniumtoxinA (RT002)	wrinkles	BELMONT; extended duration of benefits.
Phase II Interim/Top-line Results
Anergis SA	AllerT (peptides from birch pollen allergens)	allergic rhinitis	Dose-dependent IgG responses.
Menlo Therapeutics Inc.	serlopitant	pruritus due to prurigo nodularis	Reduced pruritus, well tolerated.
PolyPid Ltd.	D-Plex (doxycycline) lipid matrix	post-cardiac surgery sternal infection	No infections during use, planning Phase III.
Sanofi/Regeneron Pharmaceuticals Inc.	Dupixent (dupilumab)	atopic dermatitis	Well tolerated in pediatric patients.
Knopp Biosciences LLC/Biogen	dexpramipexole	eosinophil-associated conditions	Lowered eosinophils, well tolerated.
Samumed	SM04554	androgenetic alopecia	Increased follicle counts, well tolerated.
Tamir Biotechnology Inc.	ranpirnase, topical	human papillomavirus anogenital warts	Showed clinical benefits, well tolerated.
Leo Pharma AS	tralokinumab	atopic dermatitis	Improved itching, quality of life and well tolerated.
Phase II Initiation
Ionis Pharmaceuticals Inc./Novartis AG	AKCEA-APO(a)-LRx	hyperlipoproteinema	antisense to Lp(a) gene.
CyTuVax	HBAI20	hepatitis B prevention	In non-responders.
Esperion Therapeutics Inc.	ETC-1002	dyslipidemia	A triple oral therapy.

Marketing Approvals – March 3 to March 9, 2017

Source: Biomedtracker.

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Allergan PLC	-	Noctiva (desmopressin acetate) nasal spray	nocturnal polyuria	US	A nasal spray .
Actelion Pharmaceuticals Ltd.	-	Ledaga (chlormethine) gel	mycosis fungoides-type cutaneous T-cell lymphoma	EU	Already available in the US as Valchlor.

Data is 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 .