This novel whole-body insulin-sensitizing approach is designed to address insulin resistance independent of weight loss
PITTSBURGH — As GLP-1 therapies reshape obesity care, one biotech company is betting that the root cause of Type 2 diabetes isn’t only excessive weight but a specific fat-cell dysfunction.
AdipoPharma LLC today announced that it has
completed dosing the second cohort of participants in a Phase 1 clinical trial
in the US of PATAS, a first-in-class insulin sensitizer designed to restore
normal glucose handling in adipose tissue, with the goal of addressing Type 2
diabetes at its biological source rather than indirectly through weight loss.
Global Type 2 diabetes continues to rise and
is projected to affect 1.3 billion people by 2050. Meanwhile, the global
insulin market continues to expand, underscoring the persistence of underlying
insulin resistance.
AdipoPharma’s approach centers on adipocytes,
or fat cells, which play a critical role in regulating whole-body insulin
sensitivity. When these cells become dysfunctional, systemic insulin resistance
follows with its detrimental effects throughout the body.
A Different Strategy in a Crowded Field
Most current therapies improve glycemic
control indirectly, usually by treating the symptoms instead of the root cause –
insulin resistance. PATAS is engineered to act directly on fat cells to improve
whole-body insulin sensitivity, independent of body weight.
“Fundamentally, it’s the combination of
insulin resistance and pancreatic failure that drives Type 2 diabetes,” said
Vincent Marion, Ph.D., Scientific Founder and President of AdipoPharma. “While
we were working to address insulin resistance in preclinical studies, we
realized that PATAS-mediated rebooting of the fat cells not only increased
insulin sensitivity but also resulted in powerful protection of the muscle.”
Preclinical data demonstrates that PATAS may improve
glucose intolerance, decrease insulin resistance, reduce fatty liver disease,
preserve lean muscle mass, and maintain pancreatic function; beneficial
outcomes that will need to be confirmed in clinical trials.
The company believes this mechanism could
complement existing anti-obesity drugs, particularly as the industry explores
ways to address muscle loss and persistent metabolic dysfunction.
Phase 1 Program
The ongoing first-in-human study is a
randomized, double-blind, placebo-controlled trial evaluating safety,
tolerability, and pharmacokinetics (how the drug behaves in the body) of PATAS.
Phase 1A includes single ascending doses in
healthy volunteers. Phase 1B is planned to evaluate multiple ascending doses in
patients with Type 2 diabetes. Initial safety data is expected later this year.
“The future of diabetes treatment isn’t just
about lowering glucose,” Vincent Marion, Ph.D., added. “It’s about restoring
metabolic as well as physical health and that, we believe, will open the door
to an innovative way of treating Type 2 diabetes.”
Launching Series B Financing
AdipoPharma has completed its Series A round
that funded the initiation of its Phase 1 program. The company is currently
raising its Series B financing to support completion of Phase 1B and advance
PATAS into Phase 2 clinical trials in patients with Type 2 diabetes with or
without anti-obesity medication.
“The missing piece in diabetes care has always
been targeting insulin resistance directly,” said Alan Cherrington, Ph.D.,
AdipoPharma Board Member, Professor of Molecular Biology at Vanderbilt
University, and former President of the American Diabetes Association. “PATAS is
designed to address the underlying cause of the disease, not just its
downstream effects, and we look forward to the results of the clinical study.”
With initial Phase 1 safety data expected
later this year, AdipoPharma aims to generate early clinical signals that could
position PATAS as a new approach in the treatment of insulin resistance and
Type 2 diabetes.
About AdipoPharma AdipoPharma is a clinical-stage biotechnology
company developing therapies that target adipocyte dysfunction to treat insulin
resistance and Type 2 diabetes. Its lead candidate, PATAS, is currently in
Phase 1 clinical development. For more information, visit www.adipopharma.com.
