Cessatech pipeline
Cessatech is advancing a pipeline comprising three assets, all addressing an unmet medical need in the treatment of children. The lead candidate, CT001, a fixed-dose nasal spray for treating acute pain in children, is in the pre-launch phase in the US and the EU. CT002, a non-invasive intranasal sedation for children undergoing medical procedures (e.g., MRI scans), has an approved PIP in the EU. CT003, a topical anaesthetic, is currently in pre-clinical development
CT001 – a fixed-dose nasal spray for treating acute pain in children aged 1–17 years
Cessatech’s lead asset, CT001, is a nasal spray for acute pain relief for children aged 1-17 years who experience acute pain or pain related to medical procedures. CT001 offers fast onset, is easy to use, has an acceptable tolerability profile and a safety profile in line with known component properties and no new safety concerns identified.
The nasal spray contains a fixed combination of two well-known pain-relief medicines (ketamine and sufentanil) that are approved for injection in adults. In children, these medicines are only given separately by IV and have never been tested in combination. The fixed-dose combination offers a novel synergistic effect, allowing the sufentanil (opioid) dose to be lowered (approx. 30 percent) without reducing the analgesic effect and consequently the avoidance of undesirable side effects such as prolonged sedation and risk of respiratory depression.
CT001 development program and partnerships
CT001 is based on fifteen years of clinical experience and is a spin-out from Copenhagen University Hospital and Karolinska University Hospital in Sweden. The development program for CT001 included studies in children and adults, designed with a focus to evaluate the medicine’s efficacy, safety and usability in children. Over the course of clinical trials, the fixed-dose combination of CT001 has demonstrated a rapid, clinically meaningful reduction in pain scores, has an acceptable tolerability profile and a safety profile in line with known component properties and no new safety concerns identified.
Europe / ex-US
In Europe, Cessatech has entered an exclusive agreement with Proveca for the commercialization of CT001 world-wide excluding US. Proveca is leading the regulatory submission and commercialization of CT001 in Europe and has the exclusive rights to market and sell CT001 outside the US.
Proveca has submitted a Paediatric Use Marketing Authorisation (PUMA) Marketing Authorisation Application (MAA) for CT001 to the European Medicines Agency (EMA). Receiving a PUMA licensing grant Cessatech-developed product a Europe-wide paediatric licence, with associated regulatory exclusivity and better access to paediatric markets. In addition, patents applications have been submitted in major markets, of which some have been granted.
US
Cessatech has entered a co-development and commercialization royalty license agreement with STAQ Pharma and Ventis Pharma Corporation for CT001 in the United States, under which both parties will share development costs and net profits equally (50/50). As part of this collaboration, Ventis Pharma serves as Cessatech’s commercial partner, while STAQ Pharma acts as the manufacturing partner for the US market. STAQ contributes strong sterile manufacturing capabilities and extensive nasal spray expertise, supported by established collaborations with leading pediatric hospitals across the country. STAQ Pharma is an FDA registered outsourcing facility that enables CT001 to be marketed to their network of hospitals.