R&D HighlightsAlkermes today will provide details on the following new proprietary candidates:
- MMF Prodrug Program for the Treatment of Multiple Sclerosis: The company’s MMF prodrug program 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 and to offer advantages over the currently marketed dimethyl fumarate prodrug, TECFIDERA ®. Alkermes expects to file an Investigational New Drug (IND) application and initiate a phase 1 study in mid calendar 2014.
- ALKS 7106 for the Treatment of Pain: 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. Alkermes will present preclinical data showing 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.
- RDB 1419, a Cancer Immunotherapy Based on IL-2 and its Receptors: Alkermes will present preclinical data showing that RDB 1419, a novel biologic based on IL-2 and its receptors, preferentially expanded the number of tumor-killing cells involved in immunotherapeutic effects on cancer. Additional preclinical data demonstrated that RDB 1419 inhibited lung metastases in a model of lung cancer. The company will describe how RDB 1419 was engineered using its 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.