CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), announced completion of a $4.85 million financing. Existing investors Perseus Soros Biopharmaceutical Fund, L Capital Partners, Pappas Ventures and Omega Funds all participated in the financing. CeNeRx plans to use the proceeds to complete its ongoing Phase 2 trial of the improved formulation of its novel antidepressant TriRima as monotherapy in treatment resistant depression, as well as to support advancement of its pipeline of promising agents for a variety of CNS disorders.
“Our Phase 2 trial of TriRima in treatment resistant depression is proceeding very well and these funds will primarily be used to help complete the study,” said Barry Brand, Chief Executive Officer of CeNeRx. “The pace of enrollment has been excellent – we have enrolled almost 80% of the 360 patients targeted for this trial and hope to complete the study and report headline data by mid-2012.”
Treatment resistant depression represents a large and serious problem, with between 30-50% of depressed patients not responding to traditional antidepressant therapy. The only FDA-approved medications for treatment resistant depression are atypical antipsychotics, which are associated with significant safety concerns such as tardive dyskinesia, metabolic syndrome, hypoglycemia and diabetes. TriRima has the opportunity to fill this therapeutic gap and to be the first monotherapy for treatment resistant depression that avoids the safety issues of the atypical antipsychotics.
Mr. Brand continued, “As expected, thus far in this Phase 2 trial we have seen no signs of the food-associated hypertensive effects of conventional MAO inhibitors. In addition, blinded assays of the subjects in the trial reveal regimen compliance rates of greater that 90%, with patients exhibiting therapeutic drug levels at all measured time points. We look forward to reporting data from this TriRima Phase 2 trial during 2012.”
Depression has long been associated with reductions in key neurotransmitters (serotonin, norepinephrine and dopamine), but only recently have researchers come to understand what causes their depletion. New neuroimaging techniques have shown that these neurotransmitters are depleted due to the over- expression of monoamine oxidase A (MAO-A). TriRima is the first and only medication that specifically blocks MAO-A, thereby allowing neurotransmitter levels to normalize. This approach differs from traditional antidepressants, which seek to overcome low neurotransmitter levels primarily by concentrating the existing neurotransmitters in the gap between the neurons (the synaptic cleft), leaving the neurons themselves with a neurotransmitter deficit. By blocking MAO-A and allowing the neurotransmitters to return to normal levels, TriRima acts to correct the neurotransmitter deficit both within the neuron and within the synaptic cleft. TriRima’s target is accordingly differentiated and upstream to the approach of most traditional classes of antidepressants, with the potential for improved efficacy.
TriRima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A. TriRima acts to normalize the levels of three key neurotransmitters that positively affect mood and anxiety, and the selectivity and reversibility of TriRima are expected to eliminate or reduce the risk of food-associated cardiovascular effects of conventional MAO inhibitors.
Date: December 10, 2011
Source: CeNeRx BioPharma