Pipeline Watch: Phase III Starts With Atezolizumab, CNTX-4975 And WTX101

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 Feb. 16 and Feb. 22, 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 – Feb. 16 to Feb. 22, 2018

Lead company/partner		Compound	Indication	Comments
Phase III Suspended
Merck & Co. Inc.		verubecestat	Alzheimers disease, prodromal	APECS; unlikely to show positive benefit/risk profile.
Phase III Results Published
Gilead Sciences Inc.		Descovy (tenofovir alafenamide plus emtricitabine)	HIV/AIDS	ABC/3TS Switch; The Lancet online, Feb. 20, 2018.
Roche		Zelboraf (vemurafenib)	melanoma	BRIM8; The Lancet Oncology online, Feb. 21, 2018.
Phase III Interim/Top-line Results
Novo Nordisk AS		semaglutide, oral	diabetes, type 2	PIONEER 1; effective and well tolerated.
AbbVie Inc./Neurocrine Biosciences Inc.		elagolix	uterine fibroids	ELARIS UF-I; met efficacy endpoints.
Eli Lilly & Co.		Taltz (ixekizumab)	genital psoriasis	IXORA-Q; reduced impact on sexual activity.
Evolus Inc.		prabotulinumtoxinA	glabellar lines	EVB-003; met primary endpoint.
Mesoblast Ltd.		Prochymal	graft vs host disease	Met primary endpoint.
Updated Phase III Results
Aimmune Therapeutics Inc.		AR101	peanut allergy	PALISADE; met primary efficacy endpoint.
CytoDyn Inc.		PRO 140 (CCR5 MAb)	HIV/AIDS, refractory	Reduced HIV-1 viral load.
Dermira Inc.		glycopyrronium tosylate, topical	primary axillary hyperhidrosis	ATMOS-1, -2; improved disease symptoms, well tolerated in extension study.
AbbVie Inc./ Boehringer Ingelheim GMBH		risankizumab	psoriasis, moderate to severe	ultima-1; ultima-2; high levels of clear skin.
Celgene Corp.		Otezla (apremilast)	Behcet syndrome	RELIEF; reduced oral ulcers.
Eli Lilly & Co.		Taltz (ixekizumab)	psoriasis, moderate to severe	UNCOVER-3; efficacy sustained for three years.
Eli Lilly & Co.		Taltz (ixekizumab)	psoriatic arthritis	SPIRIT-2; sustained efficacy for one year.
Novartis AG		Cosentyx (secukinumab)	psoriasis, moderate to severe	SCULPTURE; efficacy sustained at five years.
Janssen Pharmaceutical Cos./MorphoSys AG		Tremfya (guselkumab)	psoriasis, moderate to severe	VOYAGE 2; sustained responses at 72 weeks.
Leo Pharma AS		Kyntheum (brodalumab)	psoriasis, nail	AMAGINE-2, -3; sustained symptom improvement.
Phase III Initiated
Roche		Tecentriq (atezolizumab)	liver cancer, untreated advanced	IMbrave150; combined with bevacizumab.
Centrexion Therapeutics Corp.		CNTX-4975	arthritis pain	VICTORY-1; a trans capsaicin non-opioid injection.
Vertex Pharmaceuticals Inc.		VX-659, tezacaftor and ivacaftor	cystic fibrosis	Triple combination therapy.
Wilson Therapeutics AB		WTX101	Wilson's disease	FOCuS; a copper-binding-protein.
Phase III Announced
Eli Lilly & Co./ Incyte Corp.		baricitinib	atopic dermatitis	BREEZE-AD5; in adult patients.
Seikagaku Corp./Ferring Pharmaceuticals AS		SI-6603 (Condoliase)	radicular leg pain (sciatica)	Due to lumbar disc herniation.
Amgen Inc.		Repatha (evolocumab)	hyperlipidemia	In China.
Sanofi		Soliqua (insulin glargine plus lixisenatide)	diabetes type 2	Versus Lantus in
Recro Pharma Inc.		N1539	post-surgical pain	Administered pre-surgery.
Updated Phase II Results
Apellis Pharmaceuticals Inc.		APL-2	dry age-related macular degeneration	FILLY; reduced growth rate of geographic atrophy.
Brickell Biotech Inc.		sofpironium bromide	primary axillary hyperhidrosis	Promising efficacy, well tolerated.
Gamida Cell Ltd.		NiCord, engineered umbilical cord derived cells	sickle cell anemia, cancer	Signs of efficacy.
Glenmark Pharmaceuticals Ltd.		GBR 830	atopic dermatitis	Benefits observed, well tolerated.
AbbVie Inc.		upadacitinib	atopic dermatitis	Reduced itch, improved skin lesions.
AnaptysBio Inc.		ANB020	atopic dermatitis	Rapid and sustained efficacy.
Eli Lilly & Co.		mirikizumab	psoriasis, moderate to severe	Clinically effective.
Immune Pharmaceuticals Inc.		bertilimumab	bullous pemphigoid	Positive interim results.
Seres Therapeutics Inc.		SER-287	ulcerative colitis	Clinical benefits observed.
UCB Group		bimekizumab	psoriasis, moderate to severe	BE ABLE; positive results.
AbbVie Inc.		upadacitinib	Crohn's disease	CELEST; sustained efficacy at 52 weeks.
Phase II Interim/Top-line Results
Aeras Global TB Vaccine Foundation/ Sanofi Pasteur		H4:IC31 subunit vaccine	tuberculosis prophylaxis	Prevented sustained infections in high-risk adolescents.
Athenex Inc./ Almirall SA		KX2-391 (KX01)	actinic keratosis	Well tolerated and active.
Sterna Biologicals GmbH		SB012	ulcerative colitis	SECURE; signs of efficacy, well tolerated.
Adgero biopharma		REM-001	basal cell carcinoma	Clinical responses seen
GW Pharmaceuticals PLC		GWP42006	focal epilepsy	missed primary endpoint; studies continue in autism.
Phase II Initiation
La Jolla Pharmaceutical Co.		Giapreza (angiotensin II)	hypotension/shock	Pediatric patients.
Vical Inc.		ASP2397	fungal infections	Eligible for limited use indication.
DiaMedica Inc.		DM199	ischemic stroke	REMEDY; in acute disease.

Source: Informa Pharma Intelligence’s BiomedTracker.

 

 

Marketing Approvals – Feb. 16 to Feb. 22, 2018

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Osmotica Pharmaceutical Corp.	-	Osmolex ER (amantadine)	Parkinson's disease	US	Tablets with immediate and extended release.
SUPPLEMENTAL REGULATORY APPROVAL
Torii Pharmaceutical Co. Ltd.	ALK Laboratorierne AS	Miticure (house dust mite allergens)	house dust mite allergy in children	Japan	Sublingual tablet, pediatric use.
Shionogi & Co. Ltd.	Stallergenes Greer PLC	Actair (house dust mite allergen)	house dust mite allergy in children	Japan	Sublingual tablet, pediatric use.
AstraZeneca PLC	-	Imfinzi (durvalumab)	stage III non-small cell lung cancer	US	Unresectable disease not progressing after chemotherapy and radiation therapy.

Source: Biomedtracker.

 

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.