Start of process for preparing investigational medication for NIC-001

English translation

 

NIC-001 is Nanologica’s sublingual formulation of metoclopramide for treating gastroparesis patients. The process for preparing investigational medication for the clinical study has now started.

NIC-001 is a sublingual formulation of metoclopramide, which means it is a tablet that is put under the tongue where it dissolves. The drug is absorbed through the mucous membrane beneath the tongue and diffuses into the capillaries after which it enters the venous circulation without passing the gastrointestinal tract.

Gastroparesis patients have an impaired gastrointestinal tract and may have difficulties swallowing due to the nausea the illness may cause. A sublingual formulation, which does not pass the gastrointestinal tract, may then be beneficial. The expected advantage of NIC-001is a faster and more consistent symptom relief, and increased comfort for patients.

Following a competitive tender, an agreement with Recipharm has been signed for the process of preparing investigational medication for Nanologica’s clinical study of the drug candidate NIC-001.  Recipharm, who is an associated company to Nanologica, won the competitive tender in competition with two other parties. The production is expected to be finalized during the summer of 2020.

” We believe that this product has a large potential, both from an economical perspective as well as a patient perspective, as it could present an alternative treatment for a large patient population that today has few available options. With the agreement with Recipharm, we now advance the project further towards clinic”, says Andreas Bhagwani, CEO of Nanologica.

In mid-September, Nanologica’s patent application titled “Porous silica particles for use in compressed pharmaceutical dosage form” became public. This patent application relates to NIC-001 and aims to protect the technology for using porous silica particles in tablet form for the sublingual administration of one or more drugs.

The clinical trial aims to study the safety of NIC-001 and to compare its pharmacokinetic profile to the oral formulation of metoclopramide available on the market today. Even if the results are not better, or equal to, the present oral formulation, the project is believed to be well worth completing and is believed to have good preconditions of becoming profitable, as there are few treatment options available for this group of patients.

 

For further information, please contact:

Andreas Bhagwani, CEO Nanologica
Ph: +46 70 316 17 02 or e-mail: andreas.bhagwani@nanologica.com

 

About Nanologica AB (publ)
Nanologica was founded in 2004 and is a nanotechnology company developing nanoporous silica particles for applications within life science. Nanologica is world-leading in controlling the shape, size and type of porosity of silica particles. This knowledge is applied within drug delivery and chromatography (a separation technique used in drug development and drug production). The company’s mission is to contribute to better and cheaper treatments for patients worldwide through the technology platform NLAB Silica™. Nanologica’s stock (NICA) is listed on Spotlight Stock Market. For further information, please visit www.nanologica.com.

About NIC-001
NIC-001 is a reformulation of metoclopramide for the treatment of gastroparesis. Metoclopramide is a substance used to treat impaired motility of the gut, as well as nausea and vomiting, and is the only drug approved by the FDA for the treatment of gastroparesis. The efficacy of existing metoclopramide-based drugs varies however widely, and the drugs are ineffective for many patients. The purpose of NIC-001 is to address these issues by utilizing Nanologica’s technology platform to administer the active substance sublingually. The expected advantage of NIC-001is a faster and more consistent symptom relief, and increased comfort for patients.

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