E. Kick et al. / Bioorg. Med. Chem. Lett. 25 (2015) 372–377
373
O
Several different approaches have been undertaken in an
attempt to reduce the lipogenic properties of LXR agonists while
maintaining robust RCT and anti-inflammatory properties. Based
NHNH2
O
O
R1
R2
c
a or b
S
S
N
+
Br
Br
R1
11
on work with knock-out mice showing that LXR
lipid production in liver, whereas LXRb was able to maintain RCT
functionality in LXR null mice, it has been hypothesized that LXRb
a was able to drive
R1
a
R2
N
N
R2
d
N
SO2Me
S
selective agonists would induce lower levels of triglycerides and
LDL-C.19–21 Partial agonism of NHRs has also been shown to yield
differential recruitment of co-activators and co-repressors affect-
S
Br
12
R1
5, 6, 9
R1
ing tissue selectivity, so partial agonism of LXR
a may provide an
MeO
improved therapeutic window by differentially regulating genes
in liver.22–24,13 The goal for our optimization effort was to combine
partial agonism with LXRb selectivity to achieve LXR agonists that
maintain favorable RCT and anti-inflammatory effects with
reduced lipid liabilities.
HO
N
e
N
N
N
O
SO2Me
SO2Me
S
S
9
10
Scheme 1. Synthesis of pyrazole agonists. Reagents and conditions: (a) LiHMDS,
R2CO2Me, THF, ꢀ78 °C to rt, (>98% yield); (b) (CO2CH3)2, NaOMe, MeOH, (88% yield);
(c) MeOH, reflux or AcOH, DMF, 80 °C, (65–98% yield); (d) [(3-methylsulfo-
nyl)phenyl]boronic acid, Na2CO3, Pd(PPh3)4, dioxane, H2O, 90 °C, (25–80% yield);
(e) MeMgCl, THF, 20 °C, (52% yield).
Since we initiated our effort several LXRb selective agonists
have been reported in the literature including 2a,12 2b25 and
2c.13 Agonist 2a was shown to have an improved LDL and TG lipid
profile in cynomolgus monkey plasma, possibly due to weak partial
activity at LXRa.
26 While 2a was taken into the clinic, adverse CNS
effects during the single ascending dose clinical trial resulted in the
termination of further studies,27 so it is not known if the favorable
lipid results would have been observed in humans with chronic
dosing.
In pursuing the optimization of the full pan-agonist leads 3a,
3b, and 3c28 we discovered that a pyrazole was a good replacement
for the pyridone heterocycle, and benzyl pyrazole 4 was a potent,
full pan-agonist with efficacy >90% when compared to the refer-
ence 3b. Optimization of the pyrazole was undertaken with many
analogs prepared both in array synthesis and single compound
synthesis (data not shown), and from that effort the phenyl pyra-
zole 5 was prepared with potent 12 nM binding to LXRb and 5 fold
LXR
a activity, and to identify a potent, LXRb selective partial
agonist for study in animal models.
Investigation of pyrazole 5 indicated that the ortho chlorine (R1)
on the phenyl could be effectively replaced with a trifluoromethyl
(6) improving the LXRb binding selectivity to 15 fold (Table 1).
With this compound, LXR
a efficacy was reduced to 39% while
maintaining LXRb agonist activity. Replacement of the thiophene
with a phenyl provided the biphenyl sulfones 7 and 8, which both
had similar 10–14 fold binding selectivity. However, the 4-substi-
tuted phenyl (7) yielded the more potent LXRb activity (EC50 = 49 -
nM, 61% efficacy). Agonists 5–8 all were potent agonists inducing
selectivity against LXR
ity in a cellular transactivation assay (EC50 = 108 nM, 90% efficacy)
with 65% efficacy for LXR (Fig. 1, Table 1). We were very inter-
ested in pursuing compounds that afforded <40% LXR
activity when compared to 3b. Due to the partial LXR
a
. Pyrazole 5 had potent LXRb agonist activ-
ABCA1 in HeLa cells with endogenous LXRa and LXRb receptors
providing potencies of 8–38 nM (Table 1). In order to study induc-
tion in a more physiological system, potency was also assessed in a
human whole blood assay (hWBA) for selected compounds.29
When tested for ABCA1 induction in the hWBA 7 had potent
a
a
a
agonist
agonist
activity, additional optimization was undertaken to modulate the
0.48
30 mpk 7 had only 0.6
7.8 M liver exposure at 24 h (Table 3). Since efficacy is desired
in the arterial tissues, and the undesirable triglyceride and LDL-C
production was thought to be driven by hepatic LXR activity we
did not progress compounds such as 7 with high liver drug expo-
sures. Since other pyrazoles bearing the CF3 also had high liver lev-
els in pharmacokinetic (PK) studies (data not shown), alternative
substitutions at R2 were investigated.
Replacement of the CF3 with an ester afforded 9, which had
good binding and efficacy for LXRb, although poor stability in
mouse microsomes was observed. The ester 9 served as a chemical
intermediate for the preparation of gem-dimethyl carbinol 10
(Scheme 1). The carbinol 10 had an encouraging 18 fold binding
selectivity, although the LXRb agonist potency was 10 fold lower
than 9. In mouse PK studies, 10 had an improved profile with high
4 h plasma exposures and a 3 fold liver/plasma exposure ratio at
24 h (Table 3). Due to this favorable PK profile and partial agonist
activity the carbinol was a preferred substituent as the SAR
progressed.
l
M activity (Table 3). However, when dosed to mice at
lM plasma exposure at 4 h with high
l
F3C
OH
Cl
CF3
O
O
N
HO2C
CF3
N
a
O
S
Ph
F3C
Ph
GW3965, 1b
TO-091317, 1a
F
MeO OMe
F
S
O
S
O
N
N
N
N
F
N
O
Cl
N
F
CF3
CF3
F
LXR-623, 2a
2b
2c
F
F
F
S
O
F
O
O
F
O
F
O
S
NC
NC
NC
F3C
N
N
N
S
F3C
F3C
Ph
3b
3c
3a
O
The pyrazole synthesis was initiated by Claisen condensation of
2-acetyl-5-bromo thiophene with an appropriately substituted
ester to obtain the diketone 11 (Scheme 1). Condensation with
an aryl hydrazine provided the pyrazole 12. Coupling with [(3-
methylsulfonyl)phenyl]boronic acid using palladium tetrakistri-
phenyl phosphine gave the final biaryl pyrazoles 5, 6, and 9.30
The ester 9 was treated with a methyl Grignard reagent to afford
carbinol 10. The biphenyl analogs 7 and 8 were prepared by similar
routes.
F
O
OH
F
Cl
O
O
O
O
S
S
N
N
N
N
F3C
F3C
S
S
4
5
Figure 1. Examples of LXR agonists reported in literature, and leads 3a, 3b, 3c, 4
and 5 described herein (see Table 1 for associated data).