End-to-end Support: When specialists join forces to better serve HMNC Brain Health in its phase II clinical trial

FROM DRUG PRODUCT MANUFACTURING TO CLINICAL TRIAL SUPPLY MANAGEMENT

HMNC Brain Health is a disruptive clinical stage biopharmaceutical company pioneering Precision Psychiatry, powered by its AI Platform, and focusing on Treatment-Resistant Depression (TRD) and Major Depressive Disorder (MDD).

THE CLINICAL TRIAL

BH-200-03 European Phase II clinical trial
Nelivabon program is one of HMNC Brain Health’s flagship precision psychiatry programs for MDD, in which the company develops the drug candidate Nelivaptan (BH-200) together with a companion diagnostic test. The investigational medicinal product (IMP), BH-200, is a vasopressin 1b receptor antagonist.

Started in May 2023, the clinical trial is a 14-weeks, multicentre, doubleblind, randomised, placebo-controlled phase II study with an 8-weeks treatment period to assess the efficacy and tolerability of a fixed dose of BH-200 (250 mg BID) in outpatients with MDD. HMNC Brain Health expects 324 patients to be included in this clinical trial.

Delpharm Development and Creapharm Clinical Supplies (now Myonex) have collaborated to fully meet HMNC Brain Health’s need and makes its task easier while handling end-to-end operations for both non-GMP technical batches and clinical batches:

“Our strategic alliance with Delpharm & Creapharm has enabled us to take forward our compound to a Phase II clinical study as per the planned timelines. We look forward to continuing our successful collaboration for our next projects as well.”

Daniel Gehrlach,
Associate Director, HMNC Brain Health

Providing solutions for manufacturing challenges

Due to limited API availability, Delpharm was able to reposition manufacturing batches size and reached a successful dissolution profile. The teams adapted the manufacturing planning in order to handle the technical batches manufacturing with conform and robust process and results in a short timing, due to the API’s synthesizing requirements and specifications. DELPHARM Development team was able to adapt the capsule quantity of each dosage according to the clinical trial design which evolved during the project.

The right blinding strategy

Effective blinding includes all the related traits of the drug AND of its packaging. To ensure BH-200 50 mg, BH-200 100 mg and placebo caps likelihood, size 0, Swedish-orange hard gelatine capsule are used for manufacturing of dosage strengths 50 mg and 100 mg and matching placebo (without nelivaptan dose). The primary and secondary packaging steps are fitted to the maximum quantity available of each dosage and placebo at time. The QC check ensures the likelihood as a mandatory prerequisite.

Distributing IMP all over Europe

250 shipments are planed, from Creapharm (now Myonex) Le Haillan to the clinical sites in 7 European countries. To meet local regulations, Creapharm’s (now Myonex) depot partner in Serbia acts as the importer and broker for clinical distribution to this country. Every treatment unit is labelled in the 11 languages requested to address the target countries in the clinical trial. Booklet labels were designed by Creapharm’s (now Myonex) Project Management team. The variable data are printed in-house for more flexibility.