{"id":26463,"date":"2012-04-16T03:57:07","date_gmt":"2012-04-16T07:57:07","guid":{"rendered":"http:\/\/asweetlife.org\/?p=26463"},"modified":"2015-12-30T03:26:45","modified_gmt":"2015-12-30T08:26:45","slug":"positive-results-for-biodels-ultra-rapid-acting-insulin","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=26463","title":{"rendered":"Positive Results for Biodel’s Ultra Rapid Acting Insulin"},"content":{"rendered":"

\"\"<\/a>Biodel Inc.\u00a0announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 — two proprietary ultra rapid acting formulations of recombinant human insulin (RHI).\u00a0The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the company’s previous\u00a0ultra rapid acting\u00a0insulin\u00a0formulation,\u00a0Linjeta, \u00a0used in Phase 3 clinical trials, but with improved injection site toleration characteristics.\u00a0<\/p>\n

The Phase 1 clinical trial was a single-center, randomized, double-blind, three-period crossover trial in 12 patients with type 1 diabetes.\u00a0 Each study drug was administered subcutaneously on separate days with a washout period between injections.\u00a0<\/div>\n
\n

In the phase 1 clinical trial, absorption rates of Biodel’s\u00a0ultra rapid acting\u00a0insulin’s BIOD-123 and BIOD-125 were significantly faster than that of Humalog as indicated by 64% and 54% reductions, respectively.\u00a0 In a previous clinical trial, the Linjeta formulation demonstrated a 61% reduction compared to Humalog.\u00a0 Peak metabolic effects were not significantly different between the three study drugs.\u00a0<\/p>\n

All three drugs were well tolerated, with injection site tolerability generally perceived by patients to be similar to that of their usual mealtime injections used at home.\u00a0 As measured on a 100 mm visual analog scale in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog.\u00a0 The VAS score for BIOD-125 was slightly higher as compared to Humalog.\u00a0 However, this score was markedly improved relative to the Linjeta formulation.<\/p>\n

The\u00a0encouraging\u00a0findings from these studies \u00a0will enable Biodel to advance the ultra rapid acting insulin into a Phase 2 clinical trial as early as next quarter.\u00a0 In parallel, the company will continue its development of ultra rapid acting insulin analog-based formulations, with the goal of advancing product candidates into a Phase 1 clinical trial later in 2012. \u00a0<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Biodel Inc. announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 — two proprietary ultra rapid acting formulations of recombinant human insulin (RHI). 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