Aphaia Pharma Provides Enrollment and Protocol Update for Phase 2 Trial in Individuals with Obesity
April 25 2024 - 8:30AM
Aphaia Pharma, a clinical-stage company harnessing
precision-targeted drug formulations to restore endogenous
endocrine balance for the treatment of obesity and associated
metabolic diseases, today announced that it has completed
enrollment in its Phase 2 trial evaluating the safety and efficacy
of a once-daily 12g dose of its oral glucose formulation (APHD-012)
to induce weight loss in individuals with obesity. The company also
announced that the U.S. Food and Drug Administration (FDA) has
approved the expansion of the trial’s protocol to further explore
the contribution of circadian effects in weight loss treatment. The
new protocol will include four additional cohorts, which will be
dosed with either 6g (APHD-006) or 8g (APHD-008) of Aphaia’s
formulation or their respective placebos twice per day.
With the expansion of the protocol, Aphaia aims to leverage the
beneficial effects of circadian timing, which are known to improve
metabolic diseases and weight control. Part of the strategy is to
readjust the patient’s internal clock and metabolism to optimize
long-term therapeutic outcomes for patients.
"We are delighted to have finalized enrollment of the two first
cohorts and look forward to releasing topline data from this first
part of the study by Q3 2024," said Steffen-Sebastian Bolz, M.D.,
Ph.D., chief scientific officer of Aphaia Pharma. "In addition, we
are excited to have received approval to move forward with the
twice-daily protocol of our oral glucose formulation as it will
enable us to evaluate whether treatment administration aligned with
circadian principles can potentially optimize treatment performance
and further enhance long-term benefit for patients.”
Aphaia’s oral glucose formulation distinguishes itself from
conventional obesity treatments, such as hormone replacement
therapies, through its capacity to restore the endogenous release
of the entire spectrum of metabolically active hormones. By
directly correcting the underlying pathomechanism to restore
physiological balance, it offers the potential to provide a
much-needed solution for chronic management of weight loss without
the side effects that may restrict long-term treatment with current
options.
The Phase 2 trial (NCT05385978) is a randomized, double-blind,
placebo-controlled, proof-of-concept study assessing the safety and
efficacy of Aphaia’s oral glucose formulation in adults with
obesity. It is comprised of two arms: Arm 1 includes two cohorts
totaling 174 patients randomized to receive a once-daily dose of
either APHD-012 (12g of Aphaia’s glucose formulation) or APH-012P,
a matching placebo, prior to main daily meals for six (Cohort 1) or
twelve months (Cohort 2). Arm 2 includes four cohorts with a total
of 54 additional patients randomized to receive either 6g
(APHD-006) or 8g (APHD-008) of Aphaia’s glucose formulation or
their respective placebos twice per day. The primary endpoint of
the trial is the change from baseline in percent weight compared to
placebo. The study will also evaluate exploratory secondary
endpoints, which are hallmarks of multiple metabolic diseases
closely associated with obesity.
About Aphaia’s drug candidateAphaia’s lead drug
candidate is a proprietary oral glucose formulation designed to be
released at discrete parts of the small intestine to restore
endogenous nutrient-sensing signaling pathways and stimulate the
release of the broad spectrum of enteric hormones that control
multiple homeostatic functions like appetite, hunger, satiety,
glucose metabolism and energy expenditure. This includes
glucagon-like-peptide 1 (GLP-1), peptide tyrosine-tyrosine (PYY),
glicentin and oxyntomodulin (OXM) among others.
About Aphaia PharmaAphaia Pharma is a
clinical-stage biopharmaceutical company with headquarters in
Switzerland, Canada and Puerto Rico. It harnesses proprietary
precision-targeted drug formulations to restore endogenous hormone
release from nutrient-sensing cells in the gastrointestinal tract
to treat and prevent metabolic disorders such as obesity and
associated diseases. Aphaia’s lead drug candidate, an oral glucose
formulation, has been shown to safely restore endogenous hormone
release in individuals with obesity. It is being evaluated in two
Phase 2 trials, one for chronic weight management in individuals
with obesity and the second to improve glucose tolerance in
individuals with prediabetes. The versatile design of Aphaia’s
technology platform provides an opportunity for the development of
treatments for multiple disease patterns.
Aphaia Investor ContactGünter JuchoChief
Financial Officerjucho@aphaiapharma.com
Media ContactMadelin HawtinLifeSci
CommunicationsAphaiaPharma@lifescicomms.com