CFTX-2034 for PBH
An antibody-based SSTR5 agonist designed for the treatment of Post-Bariatric Hypoglycemia (PBH) which is a serious metabolic condition that can develop after weight loss surgery.
Phase
IND-enabling studies
Target
SSTR5
Modality
Antibody
Approach
Agonist
Development rights
Confo
3
Million +
bariatric surgery procedures since 2011 in the US
160
, 000 +
patients who are living with PBH in the US
Our drug candidate to treat PBH
PBH is characterized by excessive insulin production a few hours after eating.
This can result in dangerously low blood sugar levels. Symptoms include:
- Shakiness / tremor
- Palpitations
- Cognitive impairment
- Behavioral changes
- Loss of consciousness
- Seizures
- Coma
The quality of life and independence of people living with PBH is often seriously impacted due to the anxiety and fear of these events.
CFTX-2034 is an investigational antibody drug candidate with the potential to be an effective, safe, and long-acting treatment for PBH and other conditions of Hyperinsulinemic Hypoglycemia such as Congenital Hyperinsulinemia (CHI).
CFTX-2034 is designed for the treatment of Hyperinsulinemic Hypoglycemia, with its primary indication for development of Post-Bariatric Hypoglycemia (PBH).
PBH can develop particularly after sleeve gastrectomy and Roux-en-Y gastric bypass weight loss surgery.
In PBH-affected individuals, excessive insulin and incretin production following food intake results in low blood sugar levels, called hypoglycemic events. This can lead to shakiness / tremor, palpitations, cognitive impairment, behavioral changes and dangerously debilitating neuroglycopenic symptoms of loss of consciousness, coma and seizures.
Due to anxiety and fear of these events occurring, the quality of life and independence of people living with PBH is often seriously impacted (falls, inability to work and to drive safely).
The American Society for Metabolic and Bariatric Surgery reported more than 2.8 million bariatric procedures between 2011 and 2023 in the US.
Sleeve gastrectomy is the most performed surgery, and together with Roux-en-Y gastric bypass accounts for approximately 80% of the procedures with 30-50% of these individuals reporting symptoms at least 1 year postoperatively.
In a small percentage of patients, symptoms can be persistent or severe and require hospitalization, and in the worst cases, the surgery even needs to be reversed.
No medication has been approved for PBH. Dietary management and off-label pharmacotherapy offer some resolution for a subset of patients, but especially those individuals with refractory hypoglycemic events, are in need for an effective, safe and convenient treatment.
Somatostatin receptor 5 (SSTR5) is a class A G-protein coupled receptor (GPCR) which is a key regulator of insulin secretion in the pancreas and of incretin secretion in the intestines. Activation of SSTR5 effectively reduces insulin and incretin release, the root causes of postprandial hypoglycemic episodes in PBH.
The therapeutic potential of CFTX-2034 lies in restoring the balance of insulin and incretin secretion postprandially and reducing gastrointestinal motility. In preclinical studies, CFTX-2034 has been shown to suppress insulin and incretin levels, as well as glucose levels.
Due to its long-acting properties and highly selective nature for SSTR5, CFTX-2034 is envisioned to be a convenient treatment with minimal off-target effects.
PBH experts support the feasibility of the concomitant use of CFTX-2034 and GLP-1R agonists which are increasingly being used after bariatric surgery for additional weight management benefit and/or comorbidity recurrence.