Pipeline Watch: Phase III Readouts For Daprodustat, Delafloxacin And Venetoclax

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. 26 and Nov. 1, 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. 26 to Nov. 1, 2018

Lead company/partner	Compound	Indication	Comments
PHASE III RESULTS PUBLISHED
Alkermes	ALKS 5461 (bupren- orphine/samidorphan)	major depressive disorder	FORWARD-4, -5; Molecular Psychiatry; Oct. 29, 2018.
PHASE III INTERIM/TOP-LINE RESULTS
GlaxoSmithKline plc	daprodustat	anemia due to chronic renal failure, dialysis-dependent	Met primary endpoint in Japan study.
Melinta Therapeutics Inc.	Baxdela (delafloxacin)	community-acquired pneumonia	Study 306; positive results.
AbbVie/Roche	Venclexta (venetoclax) plus obinutuzumab	chronic lymphocytic leukemia, front-line	CLL14; met primary endpoint.
ViiV Healthcare	cabtegravir/rilpivirine once-monthly injectable formulation	HIV/AIDS	FLAIR; met primary endpoint.
Theratechnologies Inc.	Trogarzo (ibalizumab-uiyk)	HIV/AIDS	Clinical benefit over the longer term.
Pharmacosmos	Monofer (iron isomaltoside)	anemia	FERWON-IDA; met primary endpoint.
Ultragenyx Pharmaceuticals Inc.	UX007 (triheptanoin)	glucose transporter type-1 deficiency syndrome	Glut1 DS; missed primary endpoint, development stopped in this disorder.
Genmab/ Johnson & Johnson	Darzalex (daratumumab) plus lenalidomide, dexamethasone	multiple myeloma	MAIA; met primary endpoint.
Esperion Therapeutics Inc.	bempedoic acid	dyslipidemia	CLEAR Wisdom; effective and well tolerated.
Novo Nordisk	oral semaglutide	diabetes, type 2	PIONEER 8; improved blood sugar control.
Takeda/Lundbeck	Trintellix (vortioxetine)	major depressive disorder	Promising personal goals approach to assessment.
UPDATED PHASE III RESULTS
Shanghai Green Valley Pharmaceutical	GV-971	Alzheimer's disease, mild-to-moderate	Improved cognition.
Novartis AG	brolucizumab	wet age-related macular degeneration	HARRIER, HAWK; more effective than aflibercept.
Astellas/Fibrogen	roxadustat	anemia due to chronic renal failure, dialysis dependent	Safe and effective in Japan study.
GenSight Biologics SA	GS010, gene therapy	Leber's hereditary optic neuropathy	REVERSE; clinical improvements.
Allergan plc/Molecular Partners AG	abicipar pegol	wet age-related macular degeneration	CEDAR, SEQUOIA; met primary endpoints.
Johnson & Johnson	Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide)	HIV/AIDS	AMBER; durable responses after 96 weeks.
ViiV Healthcare	fostemsavir (BMS-663068)	HIV/AIDS	BRIGHTE; positive results at 48 wks.
Clearside Biomedical Inc.	Xipere (triamcinolone acetonide)	macular edema due to non-infectious uveitis	PEACHTREE; effective and well tolerated.
Seattle Genetics Inc.	Adcetris (brentuximab vedotin) after ASCT	Hodgkin's lymphoma	AETHERA, ECHELON-1; clinical responses.
EyePoint Pharmaceuticals Inc.	Yutiq (fluocinolone acetonide) intravitreal implant	chronic non-infectious uveitis	Inflammation controlled.
Gilead Sciences Inc.	Biktarvy (bictegravir/ emtricitabine/tenofovir alafenamide)	HIV/AIDS	Study 1490; durable responses at 96 wks.
PHASE III COMPLETED
Esperion Therapeutics Inc.	bempedoic acid	dyslipidemia	CLEAR Harmony, Tranquility, Wisdom, Serenity; effective and well tolerated.
PHASE III INITIATED
CymaBay Therapeutics Inc.	seladelpar	primary biliary cholangitis	ENHANCE; a 52-week study.
Suzhou Kintor Pharmaceutical Inc.	proxalutamide plus abiraterone	prostate cancer, metastatic castration-resistant	A second Phase III study.
Merck & Co/Pfenex	V114 vaccine	Prevention of S pneumoniae infection	PNEU-DIRECTION; in 900 patients.
PHASE II SUSPENDED
GlaxoSmithKline plc	GSK-1325756 (danirixin)	COPD	Missed endpoint, development ended.
PHASE II INTERIM/TOP-LINE RESULTS
Grifols	albumin plus plasmapheresis	Alzheimer's disease	AMBAR; reduced disease progression.
Roche	faricimab	wet age-related macular degeneration	STAIRWAY; effective and well tolerated.
Zion Medical	Gammora	HIV/AIDS	Reduced HIV levels.
Acadia Pharmaceuticals	Nuplazid (pimavanserin)	major depressive disorder	CLARITY; encouraging results.
Galderma	nemolizumab	atopic dermatitis	Improved symptoms.
Sierra Oncology Inc.	momelotinib	myelofibrosis	Clinical benefit seen.
Trovagene Inc.	onvansertib	acute myeloid leukemia	Encouraging signs of activity.
UPDATED PHASE II RESULTS
Seattle Genetics Inc.	Adcetris (brentuximab vedotin) plus Opdivo (nivolumab)	Hodgkin's lymphoma	Clinical responses seen.
Quark Pharmaceuticals Inc.	QPI-1002	acute kidney injury after surgery	Clinical activity observed.
Retrophin Inc.	sparsentan	focal segmental glomerulosclerosis	DUET; nephroprot- ective effects seen.
Roche	PDS-1.0 (ranibizumab in port delivery system)	wet-age related macular degeneration	LADDER; patients went six months or longer between refills.
Amo Pharma Ltd.	tideglusib (AMO-02)	autism spectrum disorder	TIDE; signs of efficacy noted.
BioTime Inc.	OpRegen, cell therapy	dry age-related macular degeneration	Clinical improvements noted.
Aura Biosciences Inc.	AU-011, light activated	choroidal melanoma	Biological activity confirmed.
Horizon Pharma	teprotumumab	active thyroid eye disease	Improved diplopia.
Immune Pharmaceuticals Ltd.	bertilimuab	bullous pemphigoid	Signs of clinical activity observed.
ViiV Healthcare	cabotegravir/rilpivirine injectable regimen	HIV/AIDS	LATTE-2; durable responses at 3 years.
Integrative Research Labs Therapeutics AB	IRL752	Parkinson's disease	Signs of clinical effects.
Medicenna Therapeutics	MDNA55	brain cancer	Promising signs of clinical benefit.
NewLink Genetics Corp.	indoximod combination therapy	acute myeloid leukemia	Promising responses.
TG Therapeutics Inc.	umbralisib plus ublituximab and pembrolizumab	chronic lymphocytic leukemia	Durable responses observed.
argenx NV	cusatuzumab (ARGX-110)	acute myeloid leukemia	Reduced leukemic stem cells.
PHASE II COMPLETED
GlycoMimetics Inc.	uproleselan (GMI-1271)	acute myeloid leukemia	Clinical benefits observed.
PHASE II INITIATED
ActoBio Therapeutics/Intrexon Corp.	AG019	diabetes, type 1	Designed to induce immune tolerance with engineered Lactococcus lactis.
Janssen Biotech Inc./Tesaro	Zejula (niraparib)	prostate cancer	GALAHAD; in metastatic castration-resistant disease.
Novartis AG	asciminib	chronic myeloid leukemia	Added to imatinib therapy.
Anavex Life Sciences Corp.	ANAVEX 2-73	dementia in Parkinson's disease	In around 120 patients.
Achieve Life Sciences Inc.	cytisine	smoking cessation	ORCA-1; a plant-based alkaloid.
InflaRx NV	IFX-1	ANCA-associated vasculitis	Targets the complement system.
Sellas Life Sciences Group	Zeltherva (galinpepimut-S)	cancer	Potential vaccine.
Bavarian Nordic	BN-Brachyury	chordoma	A cancer immunotherapy.
AzurRx BioPharma Inc.	MS1819	exocrine pancreatic insufficiency	In cystic fibrosis.

Source: Informa Pharma Intelligence's Biomedtracker.

 

 

 

Marketing Approvals – Oct. 26 to Nov. 1, 2018

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Vertex Pharmaceuticals	-	Symkevi (tezacaftor/ ivacaftor)	cystic fibrosis	EU	In combination therapy.
Sandoz Inc. (Novartis)	-	Hyrimoz (adalimumab-adaz)	various	US	Biosimilar.
TherapeuticsMD Inc.	-	Bijuva (estradiol/ progesterone)	vasomotor symptoms due to menopause	US	In capsules.
Grupo Juste/IntelGenx	-	Rizaport (rizatriptan)	migraine	Spain	Oral thin film.
SUPPLEMENTAL REGULATORY APPROVAL
Merck & Co	-	Keytruda (pembrolizumab)	metastatic squamous NSCLC, first line	US	Based on the KeyNote-407 trial.
Johnson & Johnson	-	Invokana (canagliflozin)	CV event reduction	US	In type 2 diabetics with CV disease.
Johnson & Johnson	-	Invokamet (canagliflozin/ metformin)	CV event reduction	US	In type 2 diabetics with CV disease.
AbbVie/Roche	-	Venclyxto (venetoclax)	chronic lymphocytic leukemia, second-line	EU	With rituximab.
Jazz Pharmaceuticals plc	-	Xyrem (sodium oxybate)	cataplexy in pediatric patients	US	Previously approved for adults.
Astellas Pharma	-	Xtandi (enzalutamide)	high-risk non-metastatic castration resistant	EU	Based on the Phase III PROSPER trial.
Novartis AG	-	Mekinist (trametinib) plus Tafinlar (dabrafenib)	BRAF V600 mutation melanoma	Canada	After surgical removal of tumor.

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.