Aphaia Pharma Announces Positive Results from Phase 2 Trial Evaluating its Lead Drug Formulation for Prediabetes Treatment
June 20 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 its Phase 2 trial
evaluating the company’s lead oral glucose formulation for
prediabetes treatment met its primary endpoint. The trial showed a
statistically significant improvement in glucose tolerance in
individuals with a pathological Oral Glucose Tolerance Test (OGTT)
after 6 weeks of APHD-012 administration compared to placebo, with
a positive safety profile.
"We are excited to demonstrate for the first time that the
mechanism of action of APHD-012 translates into clinical efficacy,”
said Steffen-Sebastian Bolz, M.D., Ph.D., chief scientific officer
of Aphaia Pharma. “In addition to showcasing the potential of our
oral glucose formulation to manage prediabetes progression, it also
underscores its promise to deliver clinical benefits across various
indications (e.g., diabetes, obesity, among others), given its
mechanism of action in restoring natural hormone release patterns
in the intestine. We look forward to analyzing the upcoming data
from our ongoing Phase 2 trial of APHD-012 in individuals with
obesity and associated metabolic diseases to determine the best
strategic path forward.”
Christian Sina, M.D., professor of Medicine at University of
Luebeck, director of the Institute of Nutritional Medicine at UKSH,
Germany, and principal investigator of the trial, added, “I am
highly impressed with the data. It marks the first instance of a
drug demonstrating effectiveness in OGTT with a positive safety
profile, which is crucial for a medication aimed at disease
prevention. Preventing diabetes is a priority in healthcare
programs due to the significant health and economic burden
associated with this disease. Despite efforts in diet and exercise,
effective therapies to prevent or delay the onset of type 2
diabetes are currently lacking, posing a challenge for individuals
who do not respond to lifestyle changes. I eagerly anticipate
supporting the next steps for the program, which has the potential
to open a new avenue for prediabetes treatment.”
Key Trial Results include:
- In a group of healthy, prediabetic
and diabetic patients, APHD-012 (6 weeks treatment) reduced OGTT
blood glucose levels at 120 minutes post-challenge from 9.00.6 to
7.90.6 mmol/L (n=23, p=0.01); placebo treatment in the same
patients had no significant effect (8.80.4 mmol/L versus 8.50.6
mmol/L; p=0.33)
- A subgroup analysis appears to show
that APHD-012 has a larger effect size in prediabetic patients
(8.70.4 to 6.80.5 mmol/L; n=12, p=0.003); placebo had no
significant effect in this subgroup (8.60.4 versus 8.20.6 mmol/L;
p=0.25).
- In a further analysis of
prediabetic patients, APHD-012 treatment reduced OGTT area under
the curve (AUC 0-120 minutes) from 126147 to 116336 min*mmol/L
(p=0.004, n=12); the placebo treatment had no significant effect on
AUC in this subgroup (125045 to 122553 min*mmol/L;
p=0.47).
- In all diabetic patients included,
APHD-012 treatment reduced OGTT blood glucose levels at 120 minutes
post-challenge (from 13.20.7 to 11.60.5 mmol/L; n=5, p=0.0006);
placebo was not effective in this group (11.40.5 versus 12.00.6
mmol/L; p=0.59).
- A total of 13 adverse events (AEs)
were reported for 8 subjects (27%) during the 6 weeks of APHD-012
treatment, while 7 AEs were reported for 5 subjects (17%) taking
placebo treatment; no serious AEs occurred during the course of the
study.
The Phase 2 trial (NCT05803772) (EudraCT 2022-003205-29) was a
randomized, double-blind, placebo-controlled, multi-center
proof-of-concept study that evaluated the safety and efficacy of
APHD-012 (12g dose of Aphaia’s oral glucose formulation) in
approximately 30 adults with prediabetes, diabetes or healthy
individuals in a cross-over design. Patients were randomized to
receive a once daily dose of either APHD-012 or APHD-012P, a
matching placebo, for six weeks, followed by a washout period of 4
weeks, and subsequent crossover to the other opposite treatment arm
for another 6 weeks. The primary endpoint of the trial is
APHD-012’s ability to improve glucose tolerance in individuals with
a pathological oral glucose tolerance test (OGTT) after 6 weeks of
administration. The Oral Glucose Tolerance Test (OGTT) is a
diagnostic test used to assess how well the body processes glucose
by measuring blood glucose levels after consuming a glucose-rich
drink. In individuals with diabetes and prediabetes, blood glucose
levels are higher than normal due to their inability to metabolize
glucose effectively.
About PrediabetesPrediabetes is a serious
health condition where blood sugar levels are elevated but not yet
in the type 2 diabetes range. Prediabetes is becoming increasingly
common and affects more than 10% of the population in Europe, the
U.S. and Asia. Individuals with prediabetes are at increased risk
of developing type 2 diabetes or associated complications, such as
stroke or cardiovascular disease. While lifestyle changes can help
prevent the progression from prediabetes to diabetes, there is a
clear medical need for new therapeutic approaches to help control
disease evolution before diabetes, cardiovascular disease and other
metabolic disorders manifest.
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