Alkermes unveils three new drug candidates

New Molecular Entities advancing for the treatment of multiple sclerosis, pain and cancer

Alkermes has unveiled three new drug candidates, including: a monomethyl fumarate (MMF) prodrug programme for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic.

According to Alkermes, these drug candidates demonstrate the company’s focus on unmet medical needs in specific patient populations and show the productivity of its expanded R&D capabilities.

The company’s MMF prodrug programme has resulted in novel, small-molecule prodrugs of monomethyl fumarate for the treatment of multiple sclerosis. Alkermes’ MMF prodrugs are designed to rapidly and efficiently convert to MMF in the body. Alkermes expects to file an Investigational New Drug (IND) application and initiate a phase 1 study in mid 2014.

ALKS 7106 is Alkermes’ novel, small-molecule drug candidate derived from the company’s opioid modulator platform. ALKS 7106 is a potent, oral opioid analgesic designed for the treatment of pain with intrinsically low potential for abuse and overdose death, two liabilities associated with other opioid medicines.

Preclinical data shows that ALKS 7106 had more potent analgesic properties than morphine and was well tolerated at doses far in excess of those required for analgesic action. Additional preclinical data for ALKS 7106 demonstrated a ceiling effect on neurotransmitter release over a broad concentration range, suggesting low potential for abuse and overdose death. Alkermes expects to file an IND and initiate a phase 1 study of ALKS 7106 in mid calendar 2014.

Preclinical data shows that RDB 1419, a novel biologic based on IL-2 and its receptors, preferentially expanded the number of tumour-killing cells involved in immunotherapeutic effects on cancer. Additional preclinical data demonstrated that RDB 1419 inhibited lung metastases in a model of lung cancer.

RDB 1419 was engineered using the company’s proprietary fusion protein technology platform to modulate the natural mechanism of action of a biologic and to provide safety and tolerability advantages over existing therapies. Alkermes expects to conduct IND-enabling activities for RDB 1419 in calendar 2014.

‘The three new drug candidates exemplify the productivity of R&D at Alkermes – which now spans small molecules and biologics – and represent significant opportunities for us to address unmet needs for patients with major, chronic diseases: multiple sclerosis, pain and cancer,’ said Dr Elliot Ehrich, Chief Medical Officer of Alkermes. ‘Our distinctive approach is to build on a foundation of known pharmacology and clinical practice, then apply our R&D expertise and novel insights to create proprietary medicines with real value for patients and treatment systems.

‘Alkermes employs a rigorous clinical development process that incorporates state-of-the-art clinical trial techniques and robust study designs so we can obtain data early in the development process to make rapid decisions about the most promising candidates in our pipeline.’

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