Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, has signed a Drug Product manufacturing contract with CoreRx for formulating Brilacidin into granular form in unit dose sachets.
Such drug product packaging in the form of sachets provides patients with a convenient, portable, quick-mixing “instant” Brilacidin oral rinse therapy.
Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy.
The CoreRx agreement for Drug Product production aligns with one signed in April with another leading CDMO to, in parallel, bulk produce a commercial-grade supply of Brilacidin. Both of these manufacturing agreements serve to prepare for, and expedite, Brilacidin’s continued clinical development. Brilacidin is a defensin-mimetic drug candidate with unique immunomodulatory, anti-inflammatory, and antibacterial properties.
“CoreRx is pleased to have been selected by Innovation Pharmaceuticals for the development of Brilacidin sachets,” said Todd R. Daviau, President and CEO. “Having a sachet as a convenient oral therapy is long overdue in the treatment of oral mucositis, and we look forward to working with Innovation Pharmaceuticals to develop this new formulation and provide clinical trial supplies for this important indication.”
“Packaging Brilacidin in an easy-to-use sachet would likely substantially enhance its appeal and adoption among patients at risk for oral mucositis,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “IV-based oral mucositis therapies present distinct challenges to patients already overwhelmed with the burden of cancer care—requiring visitation to a hospital or a doctor’s office, and up to an hour (or more) to administer the drug. Brilacidin packaged in a sachet, in contrast, allows patients the convenience of taking their medication whether they are at home or elsewhere. Sachets are an optimal way of delivering much-needed treatments to this substantial patient population in need of an effective and easy to administer therapy.”
“This agreement with CoreRx is yet another important milestone positioning Brilacidin as one of the most promising drug candidates in late-stage development for the prevention and treatment of oral mucositis,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “CoreRx is now a valued contributor to advancing our Brilacidin development plan.”
Source: Company Press Release