Pappas Capital Announces the Passing of…

CeNeRx, expecting trial results and drug partner in 2012, raises $4.8M

Central nervous system drug development company CeNeRx BioPharma is developing an antidepressant whose novel mechanism causes fewer side effects, and the company is now in active talks with large pharmaceutical companies who could take the candidate, called TriRima, into phase 3 studies.

“We’re looking forward to (trial) results and a deal in 2012,” said CeNeRx CEO Barry Brand.

The Cary, North Carolina company has closed on a fundraise of $4.8 million that the company will apply to its portfolio of central nervous system drug candidates, chiefly TriRima, which is set to complete phase 2b trials early next year. Existing investors Perseus Soros Biopharmaceutical Fund, L Capital Partners, Pappas Ventures and Omega Funds all participated in the latest round. CeNeRx has raised more than $55 million to date.

TriRima is in a class of drugs called reversible inhibitors of monoamine oxidase, or RIMAs. The drug candidate works by blocking monoamine oxidase, an enzyme whose elevated levels are linked to depression. TriRima could be the first RIMA drug available in the United States.

CeNeRx is developing TriRima as a new drug for treatment-resistant depression. The current first line of antidepressants are selective serotonin reuptake inhibitors, or SSRIs, and serotonin-norepinephrine reuptake inhibitors, or SNRIs. But an estimated 30 percent to 50 percent of depression patients don’t respond to those drugs. Right now, the alternatives are atypical antipsychotics, which carry riskier side effects. TriRima would be a bridge between the safer first line of drugs and the more dangerous atypical antipsychotics, said Brand, a former GlaxoSmithKline (NYSE:GSK) executive who oversaw commercialization of several GSK antidepressants that include Paxil, Wellbutrin and Zyban.

TriRima is also safer in another regard. Because it has a different mechanism than a second major class of antidepressants called monoamine oxidase inhibitors, it does not lead to a potentially dangerous interaction with certain foods. MAO-Inhibitor antidepressants can affect the enzyme that metabolizes a compound called tyramine, found in fermented foods such as cheese and wine. That interaction, sometimes called a “cheese effect,” can cause a dangerous buildup of tyramine, which in turn increases cardiovascular risks.

There is considerable interest in developing novel antidepressants that comprise an estimated $20 billion market worldwide. But success in the field is far from assured. Winston-Salem, North Carolina-based Targacept (NASDAQ:TRGT) is in a high-profile partnership with AstraZeneca (NYSE:AZN) to develop TC-5214 for major depressive disorder. Targacept last month announced that the compound failed in the first of four phase 3 clinical trials for the compound.

CeNeRx’s compound appears promising, at least right now. The company is featured in the December report NeuroPerspective, published by NI Research. The report notes that RIMA drugs have shown a better side-effect profile in drugs that are now available in Europe.

“CeNeRx has put an exceptional amount of planning and care into the execution of the TriRima PhaseIIb, particularly in terms of monitoring patient enrollment and treatment compliance,” the report said. “While nothing is guaranteed in depression, this is a relatively high-likelihood-of-success trial.”

Before any partnership deals are struck, large pharmaceutical companies will be looking to see TriRima’s trial results. Many large pharmas have pared back their neurosciences operations. GSK in the last year has implemented cuts in neurosciences research as part of a review of its R&D efforts. Novartis (NYSE:NVS) recently announced it would close its neuroscience research facility in Switzerland. While Brand said he could not disclose which companies CeNeRx has spoken to, he said big pharma’s neuroscience R&D cuts mean that they’ll be looking to a small biotech such as CeNeRx to fill their pipeline.

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced completion of a $9 million financing. The financing includes a $5 million credit facility from MidCap Financial and $4 million in convertible debt from existing investors Aisling Capital, L Capital Partners and Pappas Ventures. CeNeRx plans to use the proceeds to advance its pipeline of promising clinical and preclinical stage compounds for mood disorders, neurodegenerative conditions and pain and spasticity.

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced that it has initiated a Phase II clinical trial for its lead product candidate TyrimaTM for the treatment of major depressive disorder (MDD). Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A). The primary objective of this Phase II trial is to evaluate the antidepressant efficacy of Tyrima in patients with confirmed MDD. The trial design incorporates a number of features intended to reduce the variability and placebo response often observed in MDD clinical trials.

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced completion of a $15 million Series B financing. Existing investors Aisling Capital, L Capital Partners and Pappas Ventures participated in the funding round. CeNeRx plans to use the proceeds to conduct a Phase II clinical trial of its lead product candidate TyrimaTM for the treatment of major depressive disorder (MDD), to further characterize its novel preclinical cannabinoid pipeline and potentially to acquire additional development stage compounds targeted at CNS disorders.

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced plans to advance its lead candidate TyrimaTM into Phase II trials for the treatment of depression and anxiety. This milestone is based on the positive results of the Tyrima Phase I program reported earlier this year and the recent completion of PET brain imaging studies showing that Tyrima penetrates the CNS and exhibits excellent pharmacokinetic and pharmacodynamic properties. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A).

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced plans to advance its lead candidate TyrimaTM into Phase II trials for the treatment of depression and anxiety. This milestone is based on the positive results of the Tyrima Phase I program reported earlier this year and the recent completion of PET brain imaging studies showing that Tyrima penetrates the CNS and exhibits excellent pharmacokinetic and pharmacodynamic properties. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A).

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced the initiation of human clinical trials of TyrimaTM, CeNeRx’ s new drug candidate with a triple mechanism of action for the treatment of depression and anxiety. Tyrima (formerly CX157) is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. The Phase I safety trials began this month following a successful review of the Investigational New Drug (IND) application for Tyrima by the U.S. Food and Drug Administration.

CeNeRx BioPharma, Inc., a start up bio-pharmaceutical company focused on developing new therapeutics for disorders of the central nervous system, today announced the completion of $18.5 million in series A financing.