Phase 1 completed with data readout to be reported in Q3 2023
Preliminary data indicates good safety and tolerance up to highest dose
Neurocentrx (the Company), a biopharmaceutical company specialising in oral ketamine for the treatment of mood disorders and other neurological indications, today provides a positive update on the clinical development of its lead programme, Keticap®. Neurocentrx has operations in the UK and is embarking on a growth phase and seeking corporate partners and investors.
Keticap® is an oral immediate-release ketamine formulation intended for the treatment of mood disorders such as treatment-resistant depression (TRD) and bipolar depression. The programme is in a phase 1 trial, investigating its safety, tolerability, and pharmacokinetics/pharmacodynamics effects.
The study is being conducted at King's College London. It is a double blind, randomised, placebo-controlled, partial crossover comparison of single ascending oral doses of Keticap® in healthy adult men and women. 18 subjects were randomised, to receive placebo or Keticap® at ascending doses from 40 mg up to 240 mg. The last patient was recruited in May 2023.
The initial results indicate that Keticap® is safe and well tolerated up to the highest dose level and the formulation is delivering levels of active pharmaceutical ingredient (API) equivalent to therapeutic dose levels seen in efficacy and registration trials. The full readout is expected in Q3 2023.
Neurocentrx has commenced plans for a Phase 2 proof of concept study with Keticap® to treat patients with treatment resistant bipolar depression. The study will receive scientific input from a clinical advisory board that includes Professor Allan Young, Director of the Centre for Affective Disorders, at King's College London. The plan is to enrol the first patient later this year.
Additionally, Neurocentrx is collaborating with its academic colleagues to support the use of Keticap® in an academic-led trial to treat patients who have long-term illnesses associated with depression. This has an anticipated start date in 2024.
The Company is working closely with the UK Medicines and Healthcare products Regulatory Agency (MHRA) on its proposed development programme for TRD.
Carmel Reilly, CEO at Neurocentrx, commented:
"We are entering an exciting phase in the development of Keticap®, our oral capsule ketamine for human use, with the Phase 1 trial on track to complete soon. Since our inception our goal has been to develop oral ketamine formulations aimed at treating patients suffering from a wide range of highly debilitating mood conditions, including treatment resistant depression and bipolar depression, chronic anorexia depression and niche orphan indications."
Graeme Duncan, Head of Clinical Development at Neurocentrx, commented:
"We are proud to see the positive progress being made in the development of Keticap®. We continue our commitment to improving the lives of patients who suffer from a range of mood disorders and are not responding to standard therapies by providing a cost-effective treatment that can be taken at home. The preliminary data from our Phase 1 studies is very encouraging and we look forward to announcing the full data later this year.
-Ends-
Notes to Editors
About Neurocentrx
Neurocentrx is a UK-based biopharmaceutical company specialising in oral ketamine for the treatment of mood disorders and other indications. The Company's aim is to develop and patent a range of oral capsule formulations, including abuse-deterrent products which are intended for at home-use for a range of indications. For more information, please visit: www.neurocentrx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230512005164/en/
Contacts:
Neurocentrx
Carmel Reilly
Graeme Duncan
Email: contact@neurocentrx.com
Neurocentrx Instinctif Partners (Media)
Melanie Toyne-Sewell Giulia Lasagni Batoul Ali
Tel: 0207 457 2020
Email: neurocentrx@instinctif.com
