In addition to the beginnings of the Jazz PTSD study, Revive announced its Phase III study of Bucillamine in patients with mild to moderate COVID-19 will continue.
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Jazz Pharmaceuticals is entering the new year with its newly-enrolled Phase II study of potential therapeutics for post-traumatic stress disorder. The Ireland-based company dosed the first patient in the mid-stage study of the potential first-in-class small molecule, JZP150.
Post-traumatic stress disorder (PTSD) is a common psychiatric condition that typically occurs following direct or indirect exposure to traumatic events and experiences. There is a significant burden associated with PTSD and, so far, there are no therapeutics developed that can treat the root cause of the disorder. Jazz Pharma hopes JZP150 will be the first to do so.
JZP150 is a highly selective inhibitor of the enzyme fatty acid amide hydrolase (FAAH). It is designed to address the underlying causes of PTSD, which include impairment of fear extinction and its consolidation. It is also being assessed for its potential to manage associated symptoms, including anxiety, nightmares and insomnia. As the company moves into mid-stage testing, JZP150 was granted Fast Track designation by the U.S. Food and Drug Administration for PTSD.
Rob Iannone, head of research and development and chief medical officer at Jazz, called the newly-dubbed designation a “notable recognition” of the unmet medical need in PTSD. Iannone said the regulatory agency recognized the potential benefits of JZP150’s novel mechanism of action to treat the debilitating disorder.
“The disease burden for PTSD can have a devastating impact on patients and their families for this common condition where the prevalence is expected to increase. Jazz is dedicated to developing and commercializing innovative medicines and progressing the clinical development of JZP150 is the start to a meaningful journey to help people living with PTSD,” Iannone said in a statement.
There are two antidepressants approved for PTSD, Zoloft and Paxil, but Jazz notes they have limited efficacy and do not address the root causes of the disorder. John H. Krystal, professor of translational research and professor of psychiatry, neuroscience, and psychology at Yale University, said JZP150 targets a novel mechanism in the brain. The Phase II study will provide greater information on the experimental treatment’s safety and efficacy in PTSD.
The Phase II clinical trial will assess two doses of JZP150 and will include 270 adults diagnosed with the disorder. The study’s primary endpoint will assess changes from baseline to end of treatment using a score from the Clinician-Administered PTSD Scale. The trial contains several secondary endpoints, including changes in the Clinical Global Impressions Severity scores and the Patient Global Impression of severity scales.
Revive Therapeutics Expands COVID-19 Study
In addition to the beginnings of the Jazz PTSD study, Canada’s Revive Therapeutics announced that its Phase III study of Bucillamine in patients with mild to moderate COVID-19 will continue following a nod from the Independent Data and Safety Monitoring Board. Bucillamine is an oral drug with anti-inflammatory and antiviral properties.
Revive said it has included trial participants from across the globe in order to bolster its chances of potential global regulatory approvals. With COVID-19 surging across Europe and Asia, the company has added additional trial sites in Turkey, where the virus is running rampant. Enrollment is expected to be completed in the first quarter of 2022.
Immunovant Plans Phase III Myasthenia Gravis Trial
Immunovant announced today that it “achieved alignment” with the FDA Division of Neurology 1 to advance its Phase III study in myasthenia gravis (MG). Immunovant will initiate its Phase III study of batoclimab in MG in the first half of 2022. Immunovant will assess two weekly doses of batoclimab, 680mg and 340mg, in MG patients. Details of the clinical trial will be presented in Jan. 5 investor call. A data readout is expected in 2024.
“Based on our market research, we believe that people living with myasthenia gravis desire to achieve significant clinical improvement and want to maintain this improvement without experiencing disease flares,” Pete Salzmann, Immunovant CEO said in a statement. “Our Phase III trial was designed around these insights and is intended to take advantage of batoclimab’s broad therapeutic window and a simple subcutaneous delivery device to provide a patient-friendly dosing experience.”
Palatin Technologies Begins Late-Stage Dry Eye Study
New Jersey-based Palatin Technologies launched its pivotal Phase III MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is expected to enroll up to 400 patients. Top-line results are currently expected in the second half of 2022.
Dry eye disease impacts more than 20 million people in the United States. It is characterized by insufficient moisture and lubrication in the eye’s anterior surface. This leads to dryness, inflammation, irritation, and in severe cases, permanent vision impairment.
The beginning of the MELODY-1 study marks the second melanocortin peptide Palatin has advanced into Phase III.
