Diabetes kills more Americans every year than AIDS and breast cancer combined.
In addition to being lethal, diabetes is also famously costly to treat as a result of the state of current therapies and the many conditions that diabetes exacerbates, damaging the kidneys, liver, heart, feet and eyes. The American Diabetes Association estimates that one out of every seven dollars in U.S. healthcare is spent on diabetes and its complications, totalling $327 billion per year.
Beyond diet and exercise to prevent progression of the disease, treatment options vary from daily injections of insulin to oral drugs that help regulate appetite or more directly influence blood sugar levels. Scientists industry-wide are advancing alternatives to insulin that target Glucagon-like peptide-1 (GLP-1), a hormone that stimulates insulin release.
Meeting this medical need has become a massive industry. The global market for diabetes care devices and drugs could soon reach $85.6 billion, according to a forecast from Meticulous Research.
As diabetes patients move to self-management, biotech companies are seeking to give patients more autonomy over their care and lower barriers to treatment with less invasive therapies.
Bay Area companies represent just a slice of the 172 domestic drugs in development in 2019 to to treat diabetes or its related conditions, as tracked by PhRMA.
We’ve highlighted 10 drug candidates Bay Area biotechs are testing in clinical trials.
Rezolute Inc.
HQ: Redwood City
Drug name: AB101 (basal insulin injection)
What it does: The basal-bolus regimen, consisting of daily injections of long-acting (basal) and short-acting (bolus) is considered the gold standard for treating Type 1 diabetes because it mimics the body’s natural course of insulin production. AB101 would take this therapy one step further. It would release insulin slowly over the course of a week.
Status: Currently in Phase I trials.
NGM Biopharmaceuticals, Inc. & Merck & Co.
HQ: South San Francisco
Drug name: MK-3655 (also known as NGM313)
What it does: MK-3655 is an agonistic antibody administered through monthly injection as a potential therapy for two often comorbid conditions: type 2 diabetes, and nonalcoholic steatohepatitis, or NASH, a severe fatty liver disease.
Status: Preparing for Phase IIb study.
Drug name: NGM217
What it does: An antibody designed to restore function to specific areas of the pancreas and increase insulin production in patients with diabetes.
Status: Currently in Phase I clinical trial.
Coherus BioSciences
HQ: Redwood City
Drug name: CHS-131 (PPARy modulator and partial agonist)
What it does: CHS-131 is a daily oral drug to treat patients with insulin resistance. It’s currently being tested to treat Type 2 diabetes and a commonly comorbid condition, non-alcoholic steatohepatitis (NASH) a fatty liver disease that can also contribute to heart disease in diabetes patients.
Status: CHS-131 has completed Phase II testing in diabetes and multiple sclerosis patients. Coherus is set to begin further Phase II studies of the candidate’s feasibility to treat NASH patients.
Genentech
HQ: South San Francisco
Drug name: RG7880 (IL-22 receptor agonist)
What it does: RG7880 is an injectable drug candidate targeting diabetic foot ulcers and additionally being studied to help treat inflammatory conditions such as Crohn’s disease. Nerve damage and loss of sensation are common side effects of diabetes, which along with poor blood circulation to the foot can cause minor foot injuries to become catastrophic infections — resulting in 80,000 foot amputations from diabetic complications each year in the U.S. alone. RG7880 functions by mimicking the action of naturally occurring IL-22, a cytokine which Genentech scientists liken to both “doctor and bodyguard” for its crucial role in destroying invading bacteria and healing the wounds that let them in.
Status: Currently in a Phase II trial for treating inflammatory bowel disease (IBD).
ChemoCentryx, Inc.
HQ: Mountain View
Drug name: CCX-140 (CCR2 receptor antagonist)
What it does: A pill that inhibits a receptor in kidney cells known as CCR2 that’s thought to be the culprit for excess protein production in urine. Kidney damage is a common side effect of diabetes as it often coexists with conditions such as high blood pressure that subject kidneys to additional strain. Chronic high levels of glucose (a large-sized molecule) and protein degrade the kidneys’ essential filtering mechanism, accounting for why diabetes is the leading cause of renal failure in the U.S. and responsible for a majority of kidney transplants.
Status: Completed Phase II trials. ChemoCentryx is currently recruiting volunteers for further trials for populations of people with FSGS, a form of kidney disease, and or nephrotic syndrome (excess protein).
Kodiak Sciences
HQ: Palo Alto
Drug name: KSI-301 (VEGF inhibitor)
What it does: High glucose levels can damage blood vessels in the retina, causing them to swell or break (what’s known as a diabetic macular edema) and can even cause retinal detachment. The advanced stage of diabetic retinopathy is the leading cause of blindness among working-age adults. Frequent injections into eye tissue can help but is burdensome to patients and results in under-treatment. KSI-301, an anti-blood-vessel-growth inhibitor with an improved half-life in the eye, could reduce injections to a four-to-six month frequency.
Status: Currently in Phase Ib testing with plans to begin Phase II trials this year.
Carmot Therapeutics Inc.
HQ: Berkeley
Drug name: CT-868 (dual GLP-1/GIP receptor modulator)
What it does: This drug creates sensations of fullness following a meal, which could have an influential effect on the lives of patients living with diabetes, obesity, NASH, among other diseases.
Status: Currently in Phase I trials.
Gilead Sciences
HQ: Foster City
Drug name: selonsertib (ASK-1 inhibitor)
What it does: Selonsertib is designed to inhibit ASK1, a protein whose largest presence in the body is in the kidneys, and which studies have shown promotes inflammation, cell destruction and scarring when the body is subjected to oxidative stress — a side effect of many chronic diseases such as Type 2 diabetes and other often coexisting conditions of NASH (nonalcoholic steatohepatitis) and liver disease.
Status: Since February at least two Phase III trials of selonsertib have failed. Gilead is still waiting on results from their Phase II trial of a combination regimen of selonsertib, cilofexor and firsocostat for treating patients with advanced liver scarring from NASH.
Dance Biopharm Inc.
HQ: Union City
Drug name: Dance 501
What it does: Around three million people living with type 1 diabetes in the U.S. depend on daily insulin injections to survive, and it’s common for type 2 diabetes patients to delay treatment for years to avoid a treatment that can be uncomfortable and cumbersome. An alternative method, insulin inhalers, have been around since 2006, but Dance 501 looks to be a game-changer with improvements over past models’ design and safety. The palm-sized device is designed for easy use and is equipped with sensors that would enable patients to monitor and titrate their dosage, as well as integrate that data with existing diabetes-monitoring platforms from other companies.
Status: After securing $20.5 million in their latest funding round and major investment from electronics specialist Molex Ventures LLC, Dance is closer to bringing the 501 device to Phase 3 trials as soon as next year. Dance CEO Anne Whitaker told the Business Times that 501 is just the beginning — for the same device the company is also developing inhalable fast-acting and long-acting GLP-1 analogs, which in addition to diabetes treatment scientists are studying as a treatment for cardiovascular conditions, irritable bowel syndrome, and neurodegenerative diseases such as Parkinson’s and Alzheimer’s. Because they utilize the same deliver device, these analogs could see a speedy path to market not long after Dance 501’s goal of 2023.
“We aim to revolutionize what has been a multi-billion injectable market and convert much of that into an inhaled biologics market,” Whitaker said.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.