CLINICAL TRIALS
Figure 3: Metabolic trials initiated in the past 12 months by disease
120
By Dr Cydney Brooks, Citeline’s metabolic/endocrinology director
In the metabolic/endocrinology therapeutic area, a total of 265
100
industry-sponsored Phase II to Phase III trials were initiated between
Phase III
September 1st, 2007 and August 31st, 2008. Of these, the number
initiated in type 2 diabetes and diabetic complications tops those in
other indications, paralleling the overall growing diabetes market and
80
Phase II/III
current lack of effective therapeutics. Fully 50% of trial initiations in type
2 diabetes, and 20% of all trials, involve approved or recently submitted
ts drugs targeting the incretin pathway, either as GLP-1 agonists or DPP-IV
inhibitors. Most (83%) of these incretin pathway trials involve 11
60 Phase II
different drugs that are in late-stage Phase II/III or Phase III
T
rial star development. Conversely, nearly 80% of recently initiated trials for later
stage disease, in the form of diabetic complications, represent earlier
Phase II trials.
40
Two companies and two molecular approaches dominate in recent
Phase III clinical trials activity in anaemia therapy; trials involving
Roche’s recently-approved third-generation erythropoiesis-stimulating
20 agent Mircera, and the Takeda/Affymax collaboration to develop the
synthetic erythropoietin-mimetic peptide Hematide account for 86% or
24 of 28 recent trials in anaemia. In obesity, development is weighted
toward earlier stage trials and companies with more nascent pipelines
0 that are striving to overcome the lack of effective agents and steep
osis
challenges to commercialisation success in this area. Recently initiated
GERD
emia
Anaemia
Obesity obesity
obesity trials involving pipeline drugs outweigh those for approved
agents 15 to 1. Moreover, approximately 50% of these obesity trials are
T
ype 2 diabetes
Renal disease
Osteopor
Constipation
T
ype 1 diabetes
type 1 diabetes
Hyponatr evaluating combination products, one or more components of which
Functional dyspepsia
may be approved in other indications, reflecting the concept that
Diabetic complications
T
ype 2 diabetes; targeting multiple metabolic pathways will be required for effective
weight loss.
T
ype 2 diabetes;
Source: TrialTrove; accessed September 17th, 2008
Figure 4: Metabolic trials initiated in the past 12 months by company (top 20; Phase II-III)
For diseases covered in metabolic/endocrinology in TrialTrove, 104
sponsors have initiated 265 Phase II, Phase II/III or Phase III clinical
20
trials between September 2007 and September 2008. Among the top
20 sponsors, Roche leads the list with 9% of trials, most of which
stem from its Phase III programme for its recently-approved
Phase III
anaemia drug Mircera. Of note, Roche has no other drugs in Phase II
metabolic trials initiating during this time span, and its late-stage
pipeline in the metabolic area originates from Ipsen, in a
15 co-development of the GLP-1 agonist taspoglutide that recently
Phase II/III
entered Phase III. Targeting the incretin pathway as therapy for type
2 diabetes is a prevalent approach, and nine of the top 10
companies shown in Figure 4 have either a DPP-VI inhibitor or a
ts
Phase II
GLP-1 agonist in Phase III clinical development. The smaller and
predominantly metabolic-focused Novo Nordisk is balancing
10 development of the pipeline GLP-1 agonist liraglutide in type 2
T
rial star diabetes and obesity with continued development of insulin
products. Co-development practices are common, and of the top 20
sponsors of trials initiating within this one-year period, five
programmes represent co-development efforts. Four of these are
more “traditional” partnerships between a large pharmaceutical
5 player and a smaller biotech or pharma company. Noteworthy
among this group of five, however, is the alliance between the two
giants AstraZeneca and Bristol-Myers Squibb for late-stage
development of two novel type 2 diabetes therapies, the DPP-IV
inhibitor saxagliptin and the SGLT-2 inhibitor dapagliflozin. Apart
from this collaboration, BMS has initiated one trial in the metabolic
0 area during this timeframe and AstraZeneca appears as solo
disk
tis
y
eda ylin ylin
sponsor of a few trials in gastroesophageal reflux disease. Also
Roche
v
entis
var
Lill
Vivus Eisai
y
eth
noteworthy is the lack of recently-initiated, earlier stage metabolic
ck & Co
No
peuticsT
ak Pf_izer
Am Am
ohnson T
anabe
y;
MDRNA
W Roche
v
o Norers Squibb
trials from Sanofi-Aventis; trials initiated by Sanofi-Aventis in the
Mer
eda;
No
Sanof_i-A
Thera
Lill
Ipsen;
T
ak
ogenics;
past year are all Phaase III, half of which are for the company’s
J
ohnson & J
Mitsubishi Pr GLP-1 agonist AVE0100. Trial initiations from many of the larger
Bristol-My Boehringer Ingelheim
exigen
Or
pharmaceutical companies are weighted toward Phase III
programmes, while smaller companies such as Orexigen and
MDRNA (formerly Nastech) weigh in on the Phase II side. Of the large
pharmaceutical companies, Johnson & Johnson is the only firm with
AstraZeneca;
purely early-stage pipeline development during the examined
timeframe.
Source: TrialTrove; accessed September 17th, 2008
www.scripnews.com/supplements Scrip 100
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