CLINICAL TRIALS PROFILE FOR INVERSINE

All Clinical Trials for Inversine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00319319 ↗	Nicotinic Receptor Augmentation of SSRI Antidepressants	Completed	Donaghue Medical Research Foundation	Phase 2	2003-01-01	The purpose of this study is to determine whether the nicotinic receptor antagonist mecamylamine hydrochloride (Inversine) can augment SSRI-refractory major depression symptoms, quality of life and cigarette smoking outcomes. A total of n=60 SSRI-refractory patients who are on stable doses of an SSRI are being recruited into this 8-week double-blind, randomized, placebo-controlled trial.
NCT00319319 ↗	Nicotinic Receptor Augmentation of SSRI Antidepressants	Completed	Yale University	Phase 2	2003-01-01	The purpose of this study is to determine whether the nicotinic receptor antagonist mecamylamine hydrochloride (Inversine) can augment SSRI-refractory major depression symptoms, quality of life and cigarette smoking outcomes. A total of n=60 SSRI-refractory patients who are on stable doses of an SSRI are being recruited into this 8-week double-blind, randomized, placebo-controlled trial.
NCT00455650 ↗	Study of the Effects of Mecamylamine and Varenicline in Schizophrenia	Completed	National Alliance for Research on Schizophrenia and Depression	N/A	2007-03-01	We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.

Clinical Trial Conditions for Inversine

Condition Name

Condition Name for Inversine
Intervention	Trials
Depressive Disorder	1
Major Depressive Disorder	1
Pervasive Developmental Disorder	1
Tachycardia	1

Condition MeSH

Condition MeSH for Inversine
Intervention	Trials
Depressive Disorder	3
Depression	3
Depressive Disorder, Major	2
Disease	2

Clinical Trial Locations for Inversine

Trials by Country

Trials by Country for Inversine
Location	Trials
United States	5

Trials by US State

Trials by US State for Inversine
Location	Trials
Connecticut	2
Tennessee	1
Ohio	1
Massachusetts	1

Clinical Trial Progress for Inversine

Clinical Trial Phase

Clinical Trial Phase for Inversine
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Inversine
Clinical Trial Phase	Trials
Completed	5
Active, not recruiting	1

Clinical Trial Sponsors for Inversine

Sponsor Name

Sponsor Name for Inversine
Sponsor	Trials
Yale University	2
National Alliance for Research on Schizophrenia and Depression	2
National Institutes of Health (NIH)	1

Sponsor Type

Sponsor Type for Inversine
Sponsor	Trials
Other	10
NIH	1
Industry	1

Transforming Metabolic Disorders: The Promise of Inversago's INV-202 in Clinical Trials

Introduction to Inversago and INV-202

Inversago Pharma, a Canadian biotech company, has been at the forefront of developing innovative therapies targeting the CB1 receptor, particularly for metabolic disorders. Their lead molecule, INV-202, a first-in-class peripheral CB1 inverse agonist/antagonist, has shown promising results in recent clinical trials.

The Global Epidemic of Metabolic Disorders

Metabolic disorders, including conditions such as diabetic nephropathy, non-alcoholic steatohepatitis (NASH), obesity, hypertriglyceridemia, type 1 diabetes, and Prader-Willi syndrome, are a significant global health concern. These conditions affect a vast and growing number of patients worldwide, highlighting the urgent need for effective treatments[1].

Phase 1 Clinical Trial Results for INV-202

Inversago Pharma recently completed the Phase 1 clinical trial for INV-202, with encouraging results. The trial demonstrated favorable safety, tolerability, and pharmacokinetic profiles. Participants who received once-daily oral INV-202 showed data that exceeded expectations, prompting the company to proceed with INV-202 as their lead molecule and to advance it into later-stage clinical trials[1].

Safety and Tolerability

The Phase 1 trial indicated that INV-202 is well-tolerated, with no significant adverse effects reported. This is a crucial milestone, especially considering the historical challenges associated with CB1 blockers, which often included psychiatric side effects due to brain target engagement. Peripherally-acting CB1 blockers like INV-202 aim to avoid these issues while maintaining therapeutic benefits[1].

Pharmacokinetics

The pharmacokinetic data from the trial were supportive, showing a stable and predictable drug profile. This is essential for ensuring consistent efficacy and minimizing the risk of adverse effects in future trials.

Advancement to Phase 2 Clinical Development

With the successful completion of the Phase 1 trial, Inversago is set to launch Phase 2 clinical development for INV-202. This phase will further investigate the safety and efficacy of the drug in a larger patient population. The company's decision to proceed is backed by a strong preclinical package and the promising results from the initial trial[1].

Therapeutic Potential of Peripheral CB1 Blockers

Peripheral CB1 blockers, such as INV-202, offer a new approach to treating metabolic disorders without the psychiatric side effects associated with central CB1 blockade. This class of drugs has the potential to address a wide range of unmet medical needs, including complications from obesity, NASH, and other metabolic conditions[1].

Addressing Unmet Medical Needs

Inversago's focus on metabolic disorders aligns with a growing need for effective treatments. Conditions like diabetic nephropathy and NASH are becoming increasingly prevalent, and current treatments often fall short. INV-202 represents a potential breakthrough in managing these conditions and improving patient outcomes.

Market Analysis and Projections

Growing Demand for Clinical Trials

The global clinical trials market is expected to grow significantly, driven by the increasing prevalence of chronic diseases. This growth is fueled by the rising number of registered trials, particularly in regions outside the U.S. and EU, where cost-effectiveness and easier regulatory processes are attractive[3].

Economic and Market Outlook

In the broader economic context, 2025 is expected to see continued global economic growth, albeit with some challenges. The U.S. economy is projected to achieve a soft landing with a growth rate of around 2.0%, while other regions may face headwinds due to trade policy uncertainties and tariffs. This economic landscape could impact the funding and conduct of clinical trials, but the demand for innovative treatments like INV-202 is likely to remain strong[5].

Industry Expert Insights

Dr. François Ravenelle, CEO of Inversago

"The data collected on subjects who received once-daily oral INV-202 have exceeded our expectations," said Dr. François Ravenelle, Chief Executive Officer of Inversago. "Based on these data, we have decided to proceed with INV-202 as our lead molecule, while pursuing development of our pipeline of differentiated CB1 blockers."[1]

Dr. Glenn Crater, Chief Medical Officer of Inversago

"With so many people globally affected, INV-202 holds a lot of promise for treating metabolic disorders and their complications," said Dr. Glenn Crater, Chief Medical Officer of Inversago. "We have made significant progress in our understanding of CB1 receptor biology, and confirming the desired drug product profile."[1]

Comparative Analysis with Other Therapeutic Approaches

CRISPR Clinical Trials

While INV-202 is advancing through traditional small-molecule drug development, other innovative approaches like CRISPR gene editing are also making significant strides. For example, Intellia Therapeutics' CRISPR-based treatment for transthyretin amyloidosis has shown impressive efficacy in early trials, with deep reductions in toxic protein levels. However, these treatments are still in the early stages, and their long-term safety and efficacy are yet to be fully established[4].

Key Takeaways

• Successful Phase 1 Trial: INV-202 has completed its Phase 1 clinical trial with favorable safety, tolerability, and pharmacokinetic results.
• Advancement to Phase 2: Inversago is proceeding with Phase 2 clinical development to further investigate the safety and efficacy of INV-202.
• Therapeutic Potential: Peripheral CB1 blockers like INV-202 offer a promising approach to treating metabolic disorders without psychiatric side effects.
• Market Growth: The global clinical trials market is expected to grow significantly, driven by the increasing prevalence of chronic diseases.
• Economic Outlook: The economic landscape in 2025 may present some challenges, but the demand for innovative treatments is likely to remain strong.

FAQs

What is INV-202 and how does it work?

INV-202 is a first-in-class peripheral CB1 inverse agonist/antagonist developed by Inversago Pharma. It works by blocking the CB1 receptor in peripheral tissues, which can help treat metabolic disorders without the psychiatric side effects associated with central CB1 blockade.

What were the results of the Phase 1 clinical trial for INV-202?

The Phase 1 trial showed favorable safety, tolerability, and pharmacokinetic results, exceeding the company's expectations and prompting the advancement to Phase 2 clinical development.

What conditions is INV-202 intended to treat?

INV-202 is intended to treat a range of metabolic disorders, including diabetic nephropathy, non-alcoholic steatohepatitis (NASH), complications from obesity, hypertriglyceridemia, type 1 diabetes, and Prader-Willi syndrome.

How does INV-202 compare to other therapeutic approaches like CRISPR?

While CRISPR gene editing is a promising approach, INV-202 is a small-molecule drug that has already shown positive results in Phase 1 trials. CRISPR treatments are still in the early stages and require further testing to establish long-term safety and efficacy.

What is the expected market impact of INV-202 if it is approved?

If approved, INV-202 could significantly impact the market by providing a new and effective treatment for metabolic disorders, addressing a substantial unmet medical need and potentially capturing a significant market share in the growing clinical trials and pharmaceutical markets.

Sources

1. Inversago Pharma Completes Phase 1 Clinical Trial on First-in-Class Peripheral CB1 Blocker and Provides Strategy Update. Inversago Pharma, January 17, 2022.
2. Our economic and market outlook for 2025: Global summary. Vanguard, November 25, 2024.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]. Fortune Business Insights.
4. CRISPR Clinical Trials: A 2024 Update. Innovative Genomics Institute, March 13, 2024.
5. 2025 Annual Global Market Outlook. Russell Investments.