- Once-weekly formulation of setmelanotide achieved weight
loss efficacy comparable to daily-dosing formulation
- Both weekly and daily formulations of setmelanotide were
observed to be safe and well-tolerated
LUND, Sweden, June 24, 2020 /PRNewswire/ -- Camurus'
partner Rhythm Pharmaceuticals, Inc. today announced interim data
from a Phase 2 study evaluating once-weekly setmelanotide, CAM4072,
an investigational melanocortin-4 receptor (MC4R) agonist. Healthy
people with obesity treated with the weekly formulation of
setmelanotide achieved comparable weight loss to those treated with
the daily formulation, and both weekly and daily setmelanotide were
observed to be safe and well-tolerated. Pharmacokinetic analyses
showed similar trough drug concentrations for the daily and weekly
formulations over the duration of therapy.
"The Phase 2 results are promising and show that our weekly
FluidCrystal® formulation of setmelanotide delivers
similar clinical benefits in terms of weight loss as the daily
formulation, but with a more convenient dosing regimen for patients
and potential for improved treatment adherence," said Fredrik Tiberg, President & CEO of Camurus.
"We look forward to Rhythm's next steps towards registering weekly
setmelanotide for the treatment of patients with rare genetic
disorders of obesity for whom there is a high unmet medical
need."
The Phase 2 study was designed to assess the pharmacokinetics,
safety and tolerability of the weekly formulation of setmelanotide
and its effect on reducing body weight in healthy individuals with
a body mass index (BMI) of 40kg/m2 or greater. A total
of 75 individuals were included in this interim analysis: 42
individuals were treated with weekly setmelanotide (10mg, 20mg, or
30mg doses) for 12 weeks; 23 individuals were treated with placebo
for 12 weeks; and ten individuals were treated with daily
setmelanotide (2mg daily for 1 week, followed by 3mg daily for 11
weeks).
The interim data analysis demonstrated that individuals treated
with weekly setmelanotide achieved similar weight loss to those
treated with the daily formulation over 12 weeks of therapy. The
mean difference in change from baseline on weight between each
weekly dose of 10mg, 20mg or 30mg and daily dose of 2mg/3mg was
-0.69kg (p=0.659), -0.02kg (p=0.990), and -1.71kg (p=0.296),
respectively.
The weekly setmelanotide formulation was well tolerated with no
serious adverse events, and the safety profile was similar to the
daily formulation and consistent with prior clinical experience.
Incidents of injection site reactions, hyperpigmentation and nausea
or vomiting were classified as mild by investigators.
In addition, an analysis of pharmacokinetic data measuring mean
trough drug concentrations in plasma samples taken weekly for the
duration of treatment showed that 20mg and 30mg doses of the weekly
setmelanotide formulation were very similar to the 3mg daily dose
of setmelanotide with greater through drug concentrations seen in
the 30mg weekly dose.
Rhythm is continuing to analyze the efficacy, safety and
pharmacokinetic data for weekly setmelanotide, and plans to share
these data at an upcoming medical meeting. Rhythm also plans to
discuss next steps towards registration of the weekly formulation
with the FDA.
The weekly formulation of setmelanotide, CAM4072, is based on
Camurus' FluidCrystal® injection depot technology
which Rhythm licensed to develop with setmelanotide in 2016.
About setmelanotide
Setmelanotide is an investigational, melanocortin-4 receptor
(MC4R) agonist. The MC4R is part of the key biological pathway that
independently regulates energy expenditure and appetite. Variants
in genes may impair the function of the MC4R pathway, potentially
leading to insatiable hunger and early-onset, severe obesity.
Rhythm is currently developing setmelanotide as a targeted therapy
to restore the function of an impaired MC4R pathway and, in so
doing, reduce hunger and weight in patients with rare genetic
disorders of obesity. Currently, no pharmacologic therapies exist
to treat these conditions. The FDA has granted Breakthrough Therapy
designation to setmelanotide for the treatment of obesity
associated with genetic defects upstream of the MC4R in the central
melanocortin pathway, which includes pro-opiomelanocortin (POMC)
deficiency obesity and leptin receptor (LEPR) deficiency obesity.
The European Medicines Agency (EMA) has also granted PRIority
MEdicines (PRIME) designation for setmelanotide for the treatment
of obesity and the control of hunger associated with deficiency
disorders of the MC4R pathway. Both the FDA and EMA have granted
orphan drug status to setmelanotide for POMC and LEPR deficiency
obesities. The FDA has accepted Rhythm's New Drug Application (NDA)
for daily administered setmelanotide for the treatment of POMC and
LEPR deficiency obesities, granted Priority Review of the NDA and
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
November 27, 2020. Rhythm expects to
complete submission of a Marketing Authorization Application (MAA)
for daily administered setmelanotide to treat individuals living
with POMC deficiency obesity or LEPR deficiency obesity to the EMA
in the second quarter of 2020.
About Rhythm Pharmaceuticals
Rhythm is a late-stage biopharmaceutical company focused on
the development and commercialization of therapies for the
treatment of rare genetic disorders of obesity. In August 2019, the company announced positive
topline results from pivotal Phase 3 clinical trials of
setmelanotide, its MC4R agonist, in people living with POMC
deficiency obesity or LEPR deficiency obesity and, in March 2020, completed its first rolling NDA
submission to the FDA. Rhythm is also evaluating setmelanotide for
reduction in hunger and body weight in a pivotal Phase 3 trial in
people living with Bardet-Biedl and Alström syndromes, with topline
data from this trial expected in the fourth quarter of 2020 or
early in the first quarter of 2021. Rhythm is based in Boston, MA, US.
About Camurus
Camurus is a Swedish, science-led biopharmaceutical company
committed to developing and commercializing innovative, long-acting
medicines for the treatment of severe and chronic conditions. New
drug products with best-in-class potential are conceived based on
the company's proprietary FluidCrystal® drug
delivery technologies and its extensive R&D expertise. Camurus'
clinical pipeline includes products for the treatment of cancer,
endocrine diseases, pain and addiction, which are developed
in-house and in collaboration with international pharmaceutical
companies. The company's shares are listed on Nasdaq Stockholm
under the ticker CAMX. For more information, visit
www.camurus.com.
For more information
Fredrik Tiberg PhD, President & CEO
Tel. +46 (0)46-286-46-92
fredrik.tiberg@camurus.com
Fredrik Joabsson PhD
Chief Business Development Officer
Tel. +46 (0)70-776-17-37
ir@camurus.com
This is information that Camurus AB is obliged to make public
pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the managing
director, at 2:00 pm CET on
24 June 2020.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/camurus-ab/r/positive-results-from-phase-2-study-of-once-weekly-fluidcrystal--formulation-of-setmelanotide-in-hea,c3140955
The following files are available for download:
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