Pipeline Watch: Top-Line Phase III Results For Satralizumab, Lemborexant 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 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 Oct. 12 and Oct. 18, 2018, divided by event type.

Events can include Phase II and Phase III clinical 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 – Oct. 12 to Oct. 18, 2018

Lead company/partner	Compound	Indication	Comments
PHASE III INTERIM/TOP-LINE RESULTS
Chugai/Roche	satralizumab	neuromyelitis optica spectrum disorder	SAkuraSky; reduced risk of relapse.
Eisai/Purdue Pharma	lemborexant	insomnia	SUNRISE 2; positive results.
Sanofi/Regeneron	Dupixent (dupilumab)	chronic rhinosinusitis with nasal polyposis	SINUS-24, -52; met primary and secondary endpoints.
Merck & Co.	Keytruda (pembrolizumab) plus Inlyta (axitinib)	renal cell cancer, first-line	KEYNOTE-426; met overall survival and PFS endpoints.
Roche	Kadcyla (trastuzumab emtansine)	breast cancer, HER-2 positive, residual disease	KATHERINE; reduced risk of recurrence or death.
Bristol-Myers Squibb	Opdivo (nivolumab)	small cell lung cancer, previously treated, relapsed	CheckMate 331; missed overall survival primary endpoint.
Novo Nordisk	FIAsp (insulin aspart)	diabetes, type 1, in children	Onset 7; an option for daily regimen.
Allergan	ubrogepant	migraine	Safe in two long-term studies.
Diurnal Group plc	Chronocort (hydrocortisone) modified release	congenital adrenal hyperplasia	DIUR-006 safety extension study; sustained benefit observed.
UPDATED PHASE III RESULTS
Trevena Inc.	oliceridine	acute pain	ATHENA-1; well tolerated in open-label safety study.
BeyondSpring Pharmaceuticals Inc.	plinabulin	neutropenia	Protective-1; mechanism of action explored.
Novartis AG	Cosentyx (secukinumab)	psoriatic arthritis, ankylosing spondylitis	FUTURE 1, MEASURE 1; improved symptoms long-term.
Cassiopea SpA	Winlevi (clascoterone) topical	acne	Met primary and secondary endpoints.
GenSight Biologics SA	GS010	Leber's hereditary optic neuropathy	REVERSE; showed clinical improvement.
Vertex Pharmaceuticals Inc.	Kalydeco (ivacaftor)	cystic fibrosis, in infants	ARRIVAL; supports early therapy.
PHASE III INITIATED
Galera Therapeutics Inc.	avasopasem manganese (GC4419)	oral mucositis	ROMAN; in cancer patients.
PHASE II INTERIM/TOP-LINE RESULTS
Krystal Biotech Inc.	KB103	epidermolysis bullosa	Clinically meaningful benefit.
Daiichi Sankyo	quizartinib	acute myeloid leukemia	Achieved primary endpoint.
Pharnext	PXT3003	Charcot-Marie Tooth disease	PLEO-CMT; met primary endpoint.
Eiger BioPharmaceuticals Inc.	avexitide	hypoglycemia	PREVENT; positive results.
Cannabics Pharmaceuticals Inc.	cannabics SR (cannabis extract)	cachexia in cancer	Signs of clinical improvement.
Eiger BioPharmaceuticals Inc.	ubenimex	lower leg lymphedema	ULTRA; missed primary and secondary endpoints.
Pharming Group NV	Ruconest (rhC1INH)	acute kidney injury	PROTECT; positive results.
ArQule Inc.	miransertib	proteus syndrome	Signs of efficacy.
UCB SA	rozanolixizumab	myasthenia gravis	MG0002; clinical benefits observed.
DS Biopharma	DS107G	atopic dermatitis	ADvance; improved symptoms.
Bone Therapeutics SA	JTA-004	osteoarthritis pain	Safe and effective.
UPDATED PHASE II RESULTS
Merck KGaA	evobrutinib	multiple sclerosis	Met primary endpoint, reduced CNS lesions.
Targovax	TG01, neoantigen cancer vaccine	pancreatic cancer	Encouraging disease-free survival.
ValiSeek Ltd.	VAL401	non-small cell lung cancer	Preliminary efficacy signal.
Cellect Biotechnology Ltd.	ApoGraft	graft-vs-host disease	ApoGraft01; signs of efficacy.
PellePharm Inc.	patidegib gel	basal cell carcinoma in Garlin syndrome	Study 201, 202; clinical clearance.
Replicor Inc.	REP 2139 Mg	hepatitis B	Functional cures achieved.
resTORbio Inc.	RTB101	respiratory tract infections in elderly.	Decreased incidence and severity.
Aeglea BioTherapeutics Inc.	pegzilarginase	arginase-1 deficiency	Clinical improvement observed.
Eiger BioPharmaceuticals inc.	pegylated interferon lambda	hepatitis D	LIMT HDV; positive activity.
Rocket Pharmaceuticals Inc.	RP-L102, gene therapy	Fanconi anemia	Signs of efficacy.
PHASE II INITIATED
Vaximm AG	VXM01	brain cancer	Plus avelumab.
Karuna Pharmaceuticals Inc.	KarXT (karuna-xanomeline-trospium)	psychosis in schizophrenia	A co-formulation.
OncoSec Medical Inc.	TAVO (tavokinogene telsepslamid)	breast cancer, triple negative	KEYNOTE-890; with pembrolizumab.
Aimmune Therapeutics Inc./ Regeneron/Sanofi	AR101 plus dupilumab	peanut allergy	Adjunctive therapy.
PolyPid Ltd.	D-PLEX (doxycycline) polymer matrix	infections following surgery	At incisional sites.
Abide Therapeutics Inc.	ABX-1431	Tourette's syndrome	An MGLL inhibitor.
Tolero Pharmaceuticals Inc.	alvocidib	myelodysplastic syndromes	Zella 102; given in sequence after decitabine.
Chimerix Inc.	brincidofovir	adenoviral viremia	Study 210, 211; at multiple sites.
Kadmon Holdings Inc.	KD025	graft-versus-host disease	ROCKstar; pivotal Phase II study.
Telix Pharmaceuticals Ltd.	TLX101	recurrent glioblastoma	In Austria.
MaaT Pharma	MaaT013	acute graft-versus-host disease	A microbiome restoration candidate.

Source: Informa Pharma Intelligence's Biomedtracker.

 

 

 

 

Marketing Approvals – Oct. 12 to Oct. 18, 2018

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Pfizer	-	Talzenna (talazoparib)	breast cancer	US	BRCA-mutated disease.
Ultragenyx Pharmaceutical	-	Mepsevii (vetronidase alfa)	mucopoly- saccharidosis VII	Brazil	Already approved in US and EU.
EyePoint Pharmaceuticals Inc.	-	Yutiq (fluocinolone acetonide)	non-infectious uveitis	US	Intravitreal implant.

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.