Cessatech A/S

Equities

CESSA

DK0061411964

End-of-day quote NORDIC GROWTH MARKET Other stock markets 06:00:00 2024-04-25 pm EDT			5-day change	1st Jan Change
6.62 ^DKK	+1.85%		+5.08%	-8.82%

Feb. 29	Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2023	CI
2023	Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2023	CI

Cessatech announces last participant dosed in pivotal trial 0205 with lead candidate CT001

September 21, 2023 at 07:57 am EDT

Last participant has been randomised in clinical trial 0205 investigating efficacy and safety of CT001 relative to placebo and two comparative active arms
Primary aim is to show that CT001 offers a better pain reduction and safety profile compared to the comparative arms and placebo
Top-line results are anticipated during Q4 2023 once data has been analysed

Copenhagen, Denmark, 21 September - Cessatech A/S ("Cessatech" or "the Company") announces that the last participant has been randomized in clinical trial 0205, investigating the postoperative analgesic efficacy of CT001 in adults, following impacted mandibular third molar extraction, a randomised, double-blind placebo-controlled trial with 220 participants.

The trial is part of the Paediatric Investigation Plan (PIP) for CT001 nasal spray that has been agreed by the European Medicines Agency. The trial is conducted in adults as it is considered unethical to perform placebo-controlled pain trials in children. The previous trials 0201, 0204, and 0206 will be combined in a final modelling and simulation study to evaluate the dose response profile for CT001. The last clinical safety study 0202 is expected to be initiated later this year.

Jes Trygved, CEO, Cessatech
We are very pleased that we have now reached the important milestone with recruitment of the last participant in trial 0205. This trial is the biggest so far in Cessatech's history with 220 adults recruited and the clinical team, dental clinics and site have really worked hard to reach this important milestone. We are grateful to both the team and the adults that participated in this trial. We now wait with excitement for the next step, the remaining follow up visits and then data will get cleaned and results analysed. We expect to have top-line results during Q4.

For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com

About Cessatech
Cessatech A/S is a Danish pharmaceutical company committed to developing and commercializing evidence-based and innovative medicines for children for the treatment of paediatric acute pain. Its lead asset (CT001) is an analgesic nasal spray for the treatment of acute and planned painful procedures in children. The advantages include needle-free administration, easy administration, a fast-acting therapeutic effect, and being medically approved for children. CT001 is at its pivotal stage of clinical development, and CT002 is at the early development phase.

https://news.cision.com/cessatech/r/cessatech-announces-last-participant-dosed-in-pivotal-trial-0205-with-lead-candidate-ct001,c3835914

https://mb.cision.com/Main/19921/3835914/2310659.pdf

Latest news about Cessatech A/S

Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2023	Feb. 29	CI
Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2023	Nov. 16	CI
Cessatech A/S Announces the Paediatric Committee Agrees to Reduce the Number of Required Children in the Final Clinical Study with CT001 from 300 to 150 Children	23-10-25	CI
Cessatech Announces Last Participant Dosed in Pivotal Trial 0205 with Lead Candidate CT001	23-09-21	CI
Cessatech Wins EU Nod for Clinical Studies of Nasal Sedation Spray in Children; Shares Soar 21%	23-09-12	MT
Cessatech A/S Announces EMA's Paediatric Committee Agrees to Paediatric Investigational Plan for CT002 for Procedural Sedation	23-09-12	CI
Cessatech A/S Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2023	23-08-24	CI
Cessatech A/S Secures DKK 5 Million Loan Facility Agreement to Support the US Launch of its Lead Program CT001	23-08-17	CI
Cessatech A/S and Ventis Pharma Announce US Partnership for CT001	23-06-27	CI
Cessatech A/S Reports Earnings Results for the First Quarter Ended March 31, 2023	23-04-29	CI
Cessatech A/S Appoints Martin Olin as the Chairman of the Board	23-03-23	CI
Cessatech A/S Reports Earnings Results for the Fourth Quarter Ended December 31, 2022	23-03-01	CI
Cessatech A/S Reports Earnings Results for the Full Year Ended December 31, 2022	23-02-28	CI
Cessatech A/S Auditor Raises 'Going Concern' Doubt	23-02-27	CI
Cessatech A/S Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2022	22-11-18	CI
Cessatech to Raise $2 Million in Rights Offer	22-11-14	MT
Cessatech Reports Successful Outcome of Pharmacokinetic Trial in Children of Lead Candidate	22-09-23	CI
Cessatech A/S Reports First Patient Dosed in Pivotal Trial of Lead Product Candidate	22-09-05	CI
Cessatech A/S Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2022	22-08-19	CI
Cessatech A/S Announces Pivotal Trial 0205 Has Obtained Regulatory Approval	22-06-30	CI
Cessatech Reports Last Patient Dosed in Pharmacokinetic Trial in Children of Lead Candidate	22-05-16	CI
Cessatech A/S Reports Earnings Results for the First Quarter Ended March 31, 2022	22-04-19	CI
Cessatech A/S Announces Board Changes	22-03-17	CI
Cessatech Reports Successful Outcome of Bioavailability Trial 0204 with CT001	22-03-08	CI
Cessatech A/S Reports Earnings Results for the Fourth Quarter Ended December 31, 2021	22-02-24	CI

Chart Cessatech A/S

Duration

Period

More charts

Company Profile

Sector

More about the company

Income Statement Evolution

More financial data