Phase 3 Adult Efficacy and Safety Trial Data Presented at Psych Congress
Cingulate Closed a
Among other highlights, the Company announced data from its Phase 3 adult efficacy and safety trial, closed a
“We are pleased with the full data received from the Phase 3 adult efficacy and safety trial, and believe it amplifies our view that the effect size seen with CTx-1301 is positioned to provide substantial benefit to the millions of ADHD patients,” said
Cingulate Closed a
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Werth Family Investment Associates Converted
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Clinical Update
- CTx-1301:
Cingulate presented full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), onSeptember 8, 2023 , at the 36th AnnualPsych Congress , inNashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
The Phase 3 CTx-1301-022 study (NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. The study was not powered for statistical significance, nor was it achieved on the primary efficacy endpoint, but demonstrated a trend toward significance in improving Permanent Product Measure of Performance (PERMP) scores with CTx-1301 compared to placebo. Clinical Global Impression Scale [CGI-S]) scores with CTx-1301 compared to placebo also showed significant improvements with a 28.6% reduction and a p-value of < 0.001. CTx-1301 demonstrated a reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the dose-optimization period. During the randomized placebo-controlled period, CTx-1301 demonstrated a reduction in AISRS scores with an effect size of 5.45 and a p-value of <0.001.Cingulate commenced the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study in lateJuly 2023 and a Phase 3 pediatric dose-optimization onset and duration study in earlyAugust 2023 , with results expected in the first half of 2024.
Assuming positive clinical results from the upcoming Phase 3 trials,Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
- CTx-2103:
Cingulate is constructing a clinical program for CTx-2103 (buspirone) for the treatment of anxiety on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Based on the pharmacokinetic profile seen in the formulation study, which was completed inSeptember 2022 , CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to allow the Company to request a Pre-IND meeting with the FDA to discuss the design of the Company’s clinical and regulatory programs for CTx-2103. Based on feedback from the FDA, the Company will work towards an IND filing in the first half of 2024. - CTx-1302: A Phase 1/2 bioavailability study in ADHD patients for CTx-1302 (dextroamphetamine), Cingulate’s second asset for the treatment of ADHD, is planned for the second half of 2024. If results from this study are successful, pivotal Phase 3 clinical trials in all patient segments for CTx-1302 are expected to begin in 2025.
Third Quarter Results
Cash Position: As of
Management continues to evaluate additional strategies to obtain funding, which may include additional equity offerings, issuance of debt, or other capital sources, including potential collaborations with other companies or other strategic transactions.
Research & Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
About Cingulate®
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the
Consolidated Balance Sheet Data | ||||||||
2023 | 2022 | |||||||
Cash, cash equivalents and short-term investments | $ | 1,986,313 | $ | 5,356,276 | ||||
Total assets | $ | 5,870,258 | $ | 11,405,057 | ||||
Total liabilities | $ | 5,966,592 | $ | 7,523,035 | ||||
Accumulated deficit | $ | (86,008,746 | ) | $ | (69,408,496 | ) | ||
Total stockholders' equity | $ | (96,334 | ) | $ | 3,882,022 |
Consolidated Statements of Operations | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 3,923,852 | $ | 2,123,114 | $ | 10,508,395 | $ | 7,063,626 | |||||||||
General and administrative | 1,825,822 | 1,845,248 | 5,453,643 | 5,963,067 | |||||||||||||
Operating loss | (5,749,674 | ) | (3,968,362 | ) | (15,962,038 | ) | (13,026,693 | ) | |||||||||
Interest and other income (expense), net | (229,380 | ) | (58,885 | ) | (638,212 | ) | (44,512 | ) | |||||||||
Loss before income taxes | (5,979,054 | ) | (4,027,247 | ) | (16,600,250 | ) | (13,071,205 | ) | |||||||||
Income tax benefit (expense) | - | - | - | - | |||||||||||||
Net loss | (5,979,054 | ) | (4,027,247 | ) | (16,600,250 | ) | (13,071,205 | ) | |||||||||
Net loss per share of common stock, basic and diluted | $ | (0.30 | ) | $ | (0.36 | ) | $ | (1.16 | ) | $ | (1.16 | ) | |||||
Investor Relations
VP, Investor & Public Relations,
TDalton@cingulate.com
913-942-2301
mkreps@darrowir.com
214-597-8200
Media Relations
Elixir Health Public Relations
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