Cingulate and Indegene announce agreement for lead ADHD drug - the first of its kind

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags ADHD Drug delivery Drug delivery systems Fda Clinical trial

An agreement has been reached to promote Cingulate Inc’s ‘first true entire active day medication’ designed to treat attention deficit hyperactivity disorder (ADHD).

Cingulate and Indegene made the recent agreement so Indegene could use its life-sciences commercial support expertise to help lead candidate CTx-1301 (dexmethylphenidate) a new investigational option being developed as an option for ADHD once it has received approval from the US Food and Drink Administration (FDA).

The companies said that of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, there is currently no available medication  offering a single oral dose that provides patients entire active-day efficacy. CTx-1301 aims to be the first medication to achieve fast onset of action - in 30 minutes or less - and efficacy that lasts up to 16 hours while improving patient tolerability.

Cingulate is hoping to move support to phase 3 clinical trials and will look to Indegene to effectively commercialize CTx-1301 nationwide following potential  FDA approval.

Cingulate recently announced the initiation of its first phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of this year (2023).

In addition, the company plans to initiate its pivotal phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“This agreement provides a clear path to commercialize CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20 billion market by providing the first true, entire-active-day treatment for ADHD.

“But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our Company,” said Shane Schaffer, Chairman and CEO, Cingulate.

“We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparalleled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm.

“Additionally, this allows Cingulate to focus on clinical development by reducing the internal resources and risks associated with building out these functional areas.”

Cingulate’s comprehensive agreement with Indegene covers most facets of the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support. The partnership is focused on driving revenue and is designed to ensure predictable cash outflow and continues through three years post-launch of CTx-1301.

“We believe the unique attributes of CTx-1301 differentiate Cingulate’s product from other available products in the market, which aligns well to Indegene’s omnichannel approach to raising awareness among physicians and patients,” said Timothy Moore, senior vice president of emerging biotech at Indegene.

CTx-1301, uses the Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

Cingulate says that while stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301, it says, is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

The company has initiated the first of two phase 3 clinical studies of CTx-1301 to support its NDA submission. The phase 3 fixed-dose trial in children and adolescents is scheduled to begin in the middle of this year (2023).

Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

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