Biosergen and Alkem Laboratories have partnered to launch Phase II and Phase III clinical trials of the BSG005 drug for the treatment of invasive fungal diseases, in India.
The latest move comes after the companies signed a co-development and license agreement for the polyene macrolide BSG005.
As part of the partnership, Alekm will be granted an exclusive licence to market the drug in India.
Alkem will manage the first patient clinical trial, which is anticipated to be initiated after the regulatory approval.
In the trial, patients with severe fungal infections such as aspergillosis, candidiasis and mucormycosis, as well as those who are not tolerant or resistant to Amphotericin B are enrolled.
BSG005 demonstrated efficacy and safety in preclinical and Phase I trials. These advancements are making the product now a suitable treatment option for these patients.
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Both companies plan to expand the use of BSG005 for similar patient groups in the US and EU through pivotal studies, after the completion of the trials in India.
Alkem Laboratories managing director Mr Sandeep Singh said: “This is a strategic fit for Alkem’s portfolio given our presence in the acute care segment, especially in hospital-based treatment.”
Dr C B Sanjeevi at Karolinska Institute assisted Biosergen in establishing the collaboration with Alkem.
Alkem has two manufacturing, and research and development sites along with 144 abbreviated new drug applications in the US.