Biosergen, Alkem Collaborate to Develop an Anti-Infective for Severe Fungal Infections

Following successful clinical trials in India, Biosergen and Alkem aim to expand its use for similar patient groups in the US and EU via pivotal trials.

Norway-based Biosergen AB has partnered with Indian pharmaceutical firm Alkem Laboratories to co-develop and licence BSG005, an innovative polyene macrolide. 

BSG005 is being developed to treat severe and challenging invasive fungal diseases and is currently undergoing phase II and phase III trials for potential sale in the Indian market. 

Given India's high rate of life-threatening fungal infections, the company aims to conduct its first-ever clinical trial in India involving patients with severe fungal diseases. 

Reportedly, the trial will take place after the successful completion of two phase I studies. Moreover, the trial will focus on patients suffering from severe fungal infections such as mucormycosis (Black Fungus), aspergillosis, and candidiasis, and those who are intolerant or resistant to treatment with Amphotericin B.

Additionally, India's Alkem Laboratories will oversee the initial clinical patient trial, which is expected to start after regulatory clearance. The Indian pharmaceutical company will also invest in the clinical development of BSG005 and will further receive an exclusive licence to market it in India. 

Based on the safety and efficacy profile demonstrated in the preclinical studies and the phase I trials, BSG005 is expected to be a suitable treatment option for patients. 

Moreover, following successful clinical trials in India, Biosergen and Alkem aim to expand its use for similar patient groups in the US and EU via pivotal trials.

Sharing his views, Sandeep Singh, MD, Alkem Laboratories, said, 'œThis is a strategic fit for Alkem's portfolio given our presence in the acute care segment, especially in hospital-based treatment.'

Founded in 2004, Biosergen AB aims to develop innovative antifungal drugs based on the latest biopharmaceutical research and development. It targets the treatment of severe and challenging-to-treat invasive fungal diseases.

While established in 1973, Alkem Laboratories is a global player in the pharmaceutical sector. The Mumbai-based company aims to become a reliable supplier of high-quality APIs to pharmaceutical companies worldwide, contributing to the global healthcare ecosystem by forging partnerships and collaborations.

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