Addex Parkinson’s product progressing in early clinical trials
Neurologists have observed for decades that Lewy bodies, clumps of aggregated proteins inside cells, appear in the brains of patients with Parkinson’s disease and other neurodegenerative diseases. The presence of Lewy bodies suggests underlying problems in protein recycling and waste disposal, leading to the puzzle: how does disrupting those processes kill brain cells? One possible
Full Post: Discovery of potential important pathway for controlling cell loss and survival in Parkinson’s disease
Addex Pharmaceuticals has announced that it has completed the first part of a two-part Phase I clinical trial to evaluate the newly developed modified release formulation of ADX48621. ADX48621 is scheduled to start a Phase IIa proof of concept study for the treatment of levodopa associated dyskinesia in Parkinson’s disease during the first half of 2009.
Chief Medical Officer Charlotte Keywood said: “we are pleased by the progress of ADX48621 and are preparing to start the Phase IIa proof of concept trial to study its utility in Parkinson’s disease dyskinesia next year.”
Part One was a randomized two-way crossover comparison study in 12 healthy subjects to test the pharmacokinetics, safety and tolerability of the original active pharmaceutical ingredient (API) in capsule with the modified release capsule. The modified release formulation achieved the predefined pharmacokinetic criteria required to continue into Part Two. Tolerability and safety monitoring parameters also supported continuing the trial.
Part Two is a double-blind, placebo-controlled, multiple ascending, repeat dose study in 24 healthy subjects to test the safety, tolerability and pharmacokinetics of three different doses of the modified release formulation.
Addex also has initiated a separate Phase I crossover trial to study ADX48621 interactions with gender and food in about 15 older healthy male and female subjects.
Top-line data from both trials are expected by year-end.
ADX48621 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). Published studies by others using mGluR5 inhibitors have shown that this mechanism has efficacy in rodent and primate models of Parkinson’s disease - both to reduce Parkinson’s disease dyskinesia and as a levodopa sparing agent.
Dyskinesias in Parkinson’s disease patients are motor fluctuations that often result from chronic levodopa therapy. Although levodopa is widely regarded as the best available treatment for Parkinson’s disease, dyskinesias occur in more than half of patients after 5 to 10 years of levodopa therapy, with the percentage of affected patients increasing over time*. To date attempts to moderate dyskinesias via pharmaceutical treatments have been largely unsuccessful.
* Obeso JA, et al. The evolution and origin of motor complications in Parkinson’s disease. Neurology. 2000;55 (suppl 4):S13-S20.
Phosphagenics Limited (”Phosphagenics”) announced today that it has initiated a phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac. The trial will compare the bioavailability and penetration of the topically applied Voltaren(R) gel (1% diclofenac), one of the leading
Full Post: Phosphagenics’ diclofenac enters trial phase in humans
Labopharm Inc. has announced that its New Drug Application (NDA) for the Company’s novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA). The action date under the Prescription Drug User
Full Post: FDA accepts Labopharm’s NDA for formulation of trazodone
Ceregene, Inc., a biopharmaceutical company, has reported clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson’s disease. The trial did not demonstrate an appreciable difference between patients treated with CERE-120 versus those in the control group. Both groups showed an approximate 7 point improvement in the protocol-defined primary
Full Post: Ceregene announces data from phase 2 clinical trial of CERE-120 for Parkinson’s
Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational. The contract, awarded by the National Institute
Full Post: Sequella, Inc. drug compound SQ109 selected for phase 1B clinical trial program
Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, has announced that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers. This study supports the further development of the drug for multiple dsDNA infections. The Company has initiated the first Phase II multi-dose clinical trial in patients.
Full Post: Chimerix completes phase I study and starts phase II multi-dose trial for CMX001