Ovid Therapeutics Reports First Quarter 2018 Financial Results and Corporate Progress
- Data readouts for Ovid’s two lead programs expected in 2018: OV101 STARS trial for adults and adolescents with Angelman syndrome (AS) in third quarter and TAK-935/OV935 Phase 1b/2a trial for adults with rare developmental and epileptic encephalopathies (dEE) in second half
- Additional clinical trials planned in 2018 with OV101 for the treatment of adolescents and young adults with Fragile X syndrome and with TAK-935/OV935 for younger patient populations with dEE and additional rare epilepsies
“We have an exceptionally talented team at Ovid, and I could not be more pleased with their continued clinical and operational execution,” said
OV101 for Angelman Syndrome
- In March, Ovid announced completion of enrollment in the 12-week Phase 2 STARS trial evaluating OV101 for the treatment of adults and adolescents ages 13 to 49 years with a confirmed diagnosis of Angelman syndrome. AS has a wide range of symptoms and the burden of this disorder is significant. The primary endpoint of the ongoing STARS trial is safety and tolerability. The trial has exploratory secondary endpoints evaluating OV101 for disease activity in several key symptoms, including behavior, sleep, gross and fine motor skills, clinical global impression, and overall healthcare-related quality of life measures.
- The company expects topline data from the Phase 2 STARS clinical trial to be available in the third quarter of 2018. Data from this trial will help inform the next stage of development for OV101 in AS.
- In April, Ovid presented two poster presentations for OV101 in AS at the
American Academy of Neurology(AAN) 70th Annual Meeting. One poster described the baseline characteristics for the 88 patients randomized in the STARS trial. Twenty-five percent of patients enrolled are adolescents and 75 percent are adults.
OV101 for Fragile X Syndrome
- In March, Ovid announced plans to initiate in 2018 the Phase 2 ROCKET multi-dose, three-arm clinical trial evaluating OV101 for the treatment of up to 30 males ages 13 to 22 who are diagnosed with Fragile X syndrome. The primary endpoint will be safety and tolerability. Secondary endpoints are expected to include an evaluation of changes in behavior during 12 weeks of treatment with OV101.
- In April, Ovid presented three poster presentations for OV101 in Fragile X syndrome at AAN, including posters describing the economic and clinical burden of this severe disorder.
TAK-935/OV935 for Rare Developmental and Epileptic Encephalopathies
- Ovid and its collaboration partner,
Takeda Pharmaceutical Company Limitedcontinue to enroll patients in a Phase 1b/2a clinical trial of TAK-935/OV935 in adults with dEE. The primary endpoint of this study is safety and tolerability. Secondary endpoints include evaluation of pharmacokinetic (PK) parameters. The trial also includes exploratory endpoints evaluating the change from baseline in seizure frequency and 24-S-hydroxycholesteral (24HC) levels. Plasma 24HC is being further assessed as a potential biomarker for TAK-935/OV935, which may inform future clinical trial designs and help clinicians individualize the use of this investigational medicine. Topline data from the Phase 1b/2a trial are expected in the second half of 2018.
- Ovid announced today the plan to initiate in 2018 additional Phase 2 studies with TAK-935/OV935 in younger patient populations with dEE and additional rare epilepsies.
- At AAN, Ovid and Takeda presented six poster presentations for TAK-935/OV935, including study participant baseline characteristics from the Phase 1b/2a clinical trial in adults with dEE.
Upcoming Preclinical Data Presentations
- Ovid plans to present preclinical data for two of its programs at the 14th
Eilat Conference on New Antiepileptic Drugs and Device(EILAT XIV) taking place May 13 -16, 2018in Madrid, Spain. The oral presentations are expected to include new preclinical data for TAK-935/OV935 in dEE, and the first presentation of preclinical data for OV329, a next generation GABA aminotransferase (GABA-AT) inhibitor with the potential to treat treatment-resistant epilepsy.
First Quarter 2018 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss was
OV101 (gaboxadol) is believed to be the only delta (δ)-selective GABAA receptor agonist in development and the first investigational medicine to specifically target the disruption of tonic inhibition, a central physiological process of the brain that is thought to be the underlying cause of certain neurodevelopmental disorders. OV101 has demonstrated in laboratory studies and animal models to selectively activate the δ-subunit of GABAA receptors, which are found in the extrasynaptic space (outside of the synapse), and thereby impact neuronal activity through tonic inhibition.
Ovid is developing OV101 for the treatment of AS and Fragile X syndrome to potentially restore tonic inhibition and relieve several of the symptoms of these disorders. In preclinical studies, it was observed that OV101 improved symptoms of AS and Fragile X syndrome. Gaboxadol has previously been tested in over 4,000 patients (approximately 950 patient-years of exposure) and was observed to have favorable safety and bioavailability profiles.
TAK-935/OV935, which is being studied in developmental and epileptic encephalopathies, is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24S-hydroxycholesterol (24HC), which then exits the brain into the blood plasma circulation. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity. Recent literature indicates 24HC is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel, implying its potential role in central nervous system diseases such as epilepsy. To Ovid and Takeda’s knowledge, TAK-935/OV935 is the only molecule with this mechanism of action in clinical development.
TAK-935/OV935 has been tested in preclinical models to provide data to support the advancement of the drug into human clinical studies in patients suffering from rare epilepsy syndromes. A novel proprietary PET ligand, developed by
TAK-935/OV935 has completed four Phase 1 clinical studies, which have assessed tolerability and target engagement at doses believed to be therapeutically relevant. The
For more information on Ovid, please visit http://www.ovidrx.com/.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding (i) the initiation, progress, timing, scope and results of clinical trials for Ovid’s product candidates, (ii) the company’s preclinical and clinical development plans, (iii) the development of new therapies for previously unidentified disorders, (iv) the number of patients to be enrolled, (v) the timing of reporting of clinical data regarding Ovid’s product candidates, and (vi) the presentation of scientific date at scientific meetings. You can identify forward-looking statements because they contain words such as “will,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the
|Condensed Statements of Operations|
|For the Three
|For the Three
|Research and development||$||8,474,557||$||31,284,429|
|General and administrative||4,955,307||2,977,864|
|Total operating expenses||13,429,864||34,262,293|
|Loss from operations||(13,429,864||)||(34,262,293||)|
|Net loss attributable to common stockholders||$||(13,182,758||)||$||(34,238,810||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.54||)||$||(3.48||)|
|Weighted-average common shares outstanding basic and diluted||24,609,050||9,838,590|
|Selected Condensed Balance Sheet Data|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||74,158,546||$||87,125,600|
|Total stockholders' equity||$||72,088,199||$||83,436,503|
1Working capital defined as current assets less current liabilities
Senior Director, Investor Relations & Public Relations