IGC Pharma Reaches Previously Disclosed 146-Patient Enrollment Target in Phase 2 CALMA Trial, Advancing Toward Topline Analysis

IGC Pharma (NYSE American:IGC) reported that its Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer's dementia has reached the planned 146-patient enrollment, with all participants randomized at baseline.

Rhea-AI Summary

IGC Pharma (NYSE American:IGC) reported that its Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer's dementia has reached the planned 146-patient enrollment, with all participants randomized at baseline.

The company will allow limited over-enrollment to offset attrition and support robust modified intent-to-treat, end-of-treatment, and exploratory analyses ahead of database lock and topline results.

Positive

• Phase 2 CALMA trial hits full 146-patient randomization target
• Randomized, double-blind, placebo-controlled design supports rigorous efficacy and safety assessment
• Planned over-enrollment aims to secure robust evaluable population for analyses
• Progress toward database activities, site closeout, and topline analysis

Negative

• Enrollment milestone reached but no efficacy or safety topline data yet disclosed
• Need for over-enrollment highlights impact of patient attrition on evaluable dataset

Argus Jun 11 session

+0.53% close to close Open Argus

Details

News Market Reaction – IGC

In the Jun 11 session, IGC gained 0.53%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement confirms that the Phase 2 CALMA trial of IGC-AD1 has reached its 146-patient enrol...

Analysis

This announcement confirms that the Phase 2 CALMA trial of IGC-AD1 has reached its 146-patient enrollment target, marking a key operational step toward database lock and topline analysis. It follows earlier updates at 70–80% enrollment and added trial sites. While the release contains no efficacy data, it advances the Alzheimer’s agitation program toward a clearer clinical readout, against a backdrop of prior financings, an effective resale registration, and modest recent share-price volatility around CALMA news.

Key Figures

Enrollment target: 146 patients Randomized at baseline: 146 participants Follow-up timepoint: Week 2

Enrollment target

146 patients

Phase 2 CALMA trial enrollment goal reached

Randomized at baseline

146 participants

Patients randomized at baseline in CALMA Phase 2 study

Follow-up timepoint

Week 2

Attrition assessed between baseline, Week 2, and end-of-treatment

Previous Clinical trial Reports

5 past events · Latest: Jun 02

Same Type 5 events

1. Jun 02

   CALMA site added

   24h Move

   -1.7%

   Added Mount Sinai site with ~80% of targeted participants completed.

2. Apr 28

   Caregiver engagement

   24h Move

   -2.1%

   Caregiver outreach as CALMA reached ~80% enrollment and neared completion.

3. Apr 22

   New Dallas site

   24h Move

   +7.7%

   Kerwin Medical Center added; enrollment around 80% with neurology expertise.

4. Apr 14

   80% enrollment

   24h Move

   +4.4%

   Reached ~80% CALMA enrollment, entering final recruitment phase.

5. Apr 07

   Tandem site added

   24h Move

   +0.9%

   New Tandem Clinical Research site; enrollment over 70% complete.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

modified intent-to-treat, randomized, double-blind, placebo-controlled, +1 more

5 terms

modified intent-to-treat medical

"to account for attrition and support robust modified intent-to-treat, end-of-treatment"

A modified intent-to-treat (mITT) population is a version of a clinical trial analysis that includes most but not all people who were originally randomized, typically excluding those who never received the study treatment or lacked key baseline data. For investors, mITT matters because it can change how effective or safe a drug appears compared with a strict all-randomized analysis; thinking of it like judging a recipe only from cooks who actually made the dish helps explain how the choice of who is counted can shift results and influence regulatory and market reactions.

randomized medical

"The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

topline analysis technical

"ahead of database activities and topline analysis."Reaching 146 baseline"

A topline analysis is a high-level review of a company's most important headline numbers—typically sales (revenue), profit margins and other primary results—meant to show whether the business is growing or shrinking. It matters to investors because it provides a quick snapshot of performance and momentum, helping decide whether to investigate further or adjust valuations, much like glancing at a car’s speedometer to judge whether you need to slow down or speed up.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Company Continuing Limited Over-Enrollment Activities to Account for Attrition and Support Robust Modified Intent-to-Treat, End-of-Treatment and Exploratory Analyses

POTOMAC, MD / ACCESS Newswire / June 11, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced that its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's dementia has reached the Company's previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline.

The Company's prior enrollment updates described progress toward this 146-patient target. Based on observed and potential attrition between baseline, Week 2, and end-of-treatment assessments, IGC Pharma plans to continue limited over-enrollment to support the target evaluable population and strengthen the robustness of the dataset ahead of database activities and topline analysis.

"Reaching 146 baseline randomizations is an important operational milestone for CALMA and reflects the dedication of our investigators, study coordinators, patients, and caregivers," said Ram Mukunda, CEO of IGC Pharma. "As the trial enters its final phase, our focus is on generating a high-quality, evaluable dataset that can support a meaningful topline analysis and the continued development of IGC-AD1 for agitation."

The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study evaluating IGC-AD1 in patients experiencing agitation associated with Alzheimer's dementia. Agitation remains one of the most challenging neuropsychiatric symptoms affecting individuals living with Alzheimer's disease and their caregivers, creating a significant need for additional therapeutic options.

Following completion of limited over-enrollment activities and patient follow-up, IGC Pharma expects to proceed with database activities, site closeout activities, and subsequent topline analysis.

About IGC Pharma (dba IGC):

IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.

Contact Information:
Andres Sanchez
Investor Relations
info@igcpharma.com
+1 301-983-0998 / +1 (202) 569-2566

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did IGC Pharma (IGC) announce about the CALMA Phase 2 trial on June 11, 2026?

IGC Pharma announced that the Phase 2 CALMA trial reached its 146-patient enrollment target. According to IGC Pharma, all 146 participants have been randomized at baseline, marking a key operational milestone and moving the study toward database activities and topline analysis.

What is the IGC-AD1 CALMA trial for agitation in Alzheimer’s dementia?

The CALMA trial is a Phase 2 study of IGC-AD1 for agitation in Alzheimer’s dementia. According to IGC Pharma, it is randomized, double-blind, and placebo-controlled, evaluating IGC-AD1 in patients experiencing agitation, a challenging neuropsychiatric symptom with significant unmet treatment need.

How many patients are enrolled in IGC Pharma’s Phase 2 CALMA trial of IGC-AD1 (IGC)?

The CALMA trial has reached a target of 146 enrolled and randomized patients. According to IGC Pharma, 146 participants were randomized at baseline, and the company plans limited over-enrollment to maintain a robust evaluable population for modified intent-to-treat and end-of-treatment analyses.

Why is IGC Pharma planning limited over-enrollment in the CALMA IGC-AD1 trial?

IGC Pharma plans limited over-enrollment to account for patient attrition and protect the evaluable sample size. According to IGC Pharma, this approach is intended to strengthen the robustness of modified intent-to-treat, end-of-treatment, and exploratory analyses ahead of database activities and topline results.

What are the next milestones for IGC Pharma’s CALMA Phase 2 trial after full enrollment?

Next milestones include completing over-enrollment, patient follow-up, and then database and site closeout activities. According to IGC Pharma, these steps will be followed by topline analysis, which is expected to inform the continued development of IGC-AD1 for agitation in Alzheimer’s dementia.

How might the CALMA Phase 2 trial progress affect IGC (IGC Pharma) investors?

Reaching full enrollment advances CALMA closer to topline data, a potential catalyst for investors. According to IGC Pharma, achieving 146 randomized patients and planning robust analyses positions the company to generate evaluable data that may guide future development decisions for IGC-AD1.