· First-in-class oral mechanism triggers natural satiety hormones, addressing key limitations of GLP-1 therapies
· Phase I data demonstrate fat mass reduction, preservation of lean mass, 80% responder rate, and no serious adverse events
Dijon, France, May 12, 2026 — EktaH, a clinical-stage biotechnology company, today reported positive preliminary Phase I results and preclinical data for its lead compound NKS-3, a modified fatty acid molecule and the first oral therapy designed to address key limitations of current GLP-1 obesity treatments.
While
GLP-1 receptor agonists such as semaglutide and tirzepatide have demonstrated
significant weight loss, patients typically regain their baseline weight within
18 months of discontinuing treatment. In addition, current therapies are
associated with loss of lean muscle mass and gastrointestinal side effects that
drive discontinuation rates above 60%. Equally important, up to one third of
obese individuals do not respond to GLP-1 treatments.
Addressing
Fat Taste Receptor Dysfunction as a Main Cause of Obesity EktaH’s
approach directly targets these limitations. NKS-3 is an orally administered
small molecule that reactivates the fat taste receptors CD36 and GPR120 in the
tongue epithelium, which are downregulated in most obese individuals. Preclinical
data have demonstrated that NKS-3 restores normal function to these receptors,
triggers the body’s own natural release of satiety hormones including GLP-1,
cholecystokinin (CCK), and peptide YY (PYY), and reduces food intake through
the body’s endogenous signaling without the need of exogenous hormone
administration.
“Our data
demonstrate that fat taste receptor dysfunction is a measurable and treatable
feature of obesity,” said
Professor Naim Khan, CSO and Co-founder of EktaH. “By restoring the body’s
own ability to sense dietary fat and regulate satiety, we are addressing
obesity at its physiological origin rather than overriding the system with
exogenous hormones. More importantly, this mechanism of action reduces the
number of non-responders.”
NKS-3
Preclinical Data: 50% Reduction in Weight Rebound After Semaglutide
Discontinuation Diet-induced
obese mice treated with semaglutide for two weeks were subsequently given
either NKS-3 or vehicle for four weeks. Animals receiving NKS-3 exhibited
approximately 50% less weight rebound compared to control animals, while
preserving lean body mass. These
findings suggest NKS-3 has significant potential as both a standalone treatment
for obesity and as a maintenance therapy following GLP-1 treatment, addressing
a critical unmet need in obesity management.
“Weight
rebound is the biggest unresolved challenge in obesity treatment,” said Xavier Boidevezi, CEO and
Co-founder of EktaH. “Our preclinical data show 50% less weight regain after
stopping semaglutide, combined with a clinical profile that preserves muscle
mass and shows no serious adverse events. This positions NKS-3 as the weight maintenance
therapy urgently needed.”
Phase
I Data: Favorable Safety Profile with Early Efficacy Signals EktaH
has completed Phase I clinical studies encompassing both a first-in-human
safety trial in 27 healthy volunteers (2022–2023) and is conducting a Single
Ascending Dose / Multiple Ascending Dose (SAD/MAD) study in 120 patients with
obesity. Across all subjects dosed to date (87+), no serious adverse events
have been reported.
Preliminary
Data from the Ongoing MAD Study (n=18, 30-day treatment): •
Broad
applicability: 80% of obese participants (15/18) demonstrated fat taste
receptors responsive to EktaH’s modified fatty acid molecules (NKS-3 or NKS-5),
indicating that the mechanism has potential to treat a wide segment of the
obese population. •
Mechanism
confirmed in humans: 30-day treatment with NKS-3 or NKS-5 stabilized or increased fat
taste receptor sensitivity in all responsive patients, confirming the
preclinical mechanism of action. •
Encouraging
body composition changes: The NKS-5 cohort (n=7) showed an average fat mass reduction of
4.30% with a simultaneous slight increase in skeletal muscle mass of 0.36% at
four weeks. In contrast, the placebo and non-responder group gained 2.48% fat
mass over the same period. •
Clean
safety profile: No serious adverse events reported in any cohort.
The
full SAD/MAD study, encompassing 120 patients with obesity across multiple dose
levels, is expected to be completed in December 2026.
Anti-Inflammatory
Activity Supports Broader Metabolic Potential Beyond
its metabolic effects, NKS-3 demonstrated potent anti-inflammatory activity in
multiple experimental models, with significant reductions in key
pro-inflammatory cytokines and modulation of central inflammatory signaling
pathways. These findings support the potential of EktaH’s approach to address
the broader inflammatory component of obesity and metabolic diseases and
represent an additional pipeline opportunity.
Phase
II Development and Outlook EktaH
has received positive scientific advice from the UK’s Medicines and Healthcare
products Regulatory Agency (MHRA) on its Phase II clinical development plan.
The Phase IIa study (SERENITY-1) is a multicenter, double-blind,
placebo-controlled, randomized, dose-finding study of NKS-3 in 126 obese
subjects, with a 12-week treatment period and 12-week follow-up. Recruitment is
planned to begin in the first half of 2027. The
Company plans to share complete Phase I results before the end of 2026 and is
currently in discussions regarding its next financing round to support Phase II
execution.
About
EktaH EktaH is a clinical-stage
biotechnology company developing first-in-class oral therapies for obesity and
metabolic diseases. The Company’s proprietary platform targets fat taste
receptors (CD36 and GPR120) — a novel mechanism that naturally stimulates the
body’s endogenous release of satiety hormones including GLP-1, CCK, and PYY,
without the need for exogenous hormone administration. EktaH
holds worldwide exclusive licenses on its core fat taste receptor technology
(patents through 2044), with confirmed freedom-to-operate in Europe and the
United States. The Company’s pipeline includes two lead molecules (NKS-3 and
NKS-5) for obesity, an anti-inflammatory program, and next-generation agonists
in early development. EktaH is ISO 9001:2015 certified and is supported by an
international Scientific Advisory Board. Founded in 2021, EktaH is
headquartered in Dijon, France.
Investor
Contact Xavier
Boidevezi, CEO and Co-founder xboidevezi@ektah.fr
| +33 6 33 41 42 31 EktaH
SAS | 6 boulevard Gabriel, 21000 Dijon, France
Media Contact akampion Ines-Regina
Buth / Francina Agosti Tel. +49 30 23
63 27 68
Forward-Looking Statements This press release contains forward-looking statements within
the meaning of applicable securities laws. These statements involve known and
unknown risks, uncertainties, and other factors that may cause actual results
to differ materially from those expressed or implied. Forward-looking
statements include, without limitation, statements regarding the potential
therapeutic benefits of NKS-3, plans for clinical development, and expected
timelines. EktaH undertakes no obligation to update forward-looking statements
to reflect events or circumstances after the date of this release.