The data for the disorder, called Angelman syndrome, suggests the OV101 15-milligram dose can improve sleep, movement skills and behavior for patients.
Ovid Therapeutics (NASDAQ:OVID) presented additional data from its Phase 2 STARS trial to treat a rare disease at the American Academy of Child and Adolescent Psychiatry (AACAP) meeting on Thursday (October 25).
As showcased in a poster presentation, the data for the disorder, called Angelman syndrome ,suggests the OV101 15 mg dose has improved sleep, movement skills and behavior of the patients. Angelman syndrome is a genetic disorder caused by the loss of a functioning gene.
In August, Ovid announced it met the primary objective of the trial, which was safety and tolerability that the drug had showed enough improvements in the symptoms of the disease.
“These results, together with those reported in August 2018, will help inform our discussions with the FDA when we meet with them later this year,” Jeremy Levin, CEO of Ovid, said in Thursday’s press release.
The STARS trial spanned 12-weeks and was placebo-controlled. A mix of 88 adolescent and adult patients with Angelman syndrome were enrolled in three separate groups. Groups were either dosed once or twice daily, or given the placebo.
The trial results saw in improvements in sleep domain, which includes: daytime sleepiness, changes in sleep efficiency and latency to sleep. The latter, also known as the amount of time it takes a person to feel awake, improved by close to 30 minutes versus the placebo.
Patients in the trial also slept at least 50 minutes less during the day, showing an improvement of close to four percent in the sleep efficiency in the naps. Overall sleep, however, was consistent with the placebo.
As for movement skills, the biggest change was in overall motor response, but other domains also saw improvements. The overall movement response was 54 percent while larger muscle movement were improved in 36 percent of the patients. From the Zeno Walkway, a track used to measure walking patients, results showed were slower and had a reduced walking flow.
After the study was finished, investigators found patients that had overall improvements in their disease had other behavior improvements. The reported improvements were in communication, challenging behavior and anxiety.
OV101 is a specialized receptor drug targeted to inhibit the central physiological process which has been discovered to cause neurodevelopmental disorders. The drug is also in development to treat Fragile X syndrome to relieve several effects of the disorders. From the US Food and Drug Administration (FDA), the drug has been granted orphan drug and fast track designations for both indications.
About one in 12,000 to 20,000 people are diagnosed with Angelman syndrome, according to the National Organization for Rare Diseases. Patients have delayed development, severe speech impairment, sleep disorders and other characteristics. There are currently no approved therapies for the disease.
Ovid has a pipeline robust with rare and neurological disorder candidates and has partnered with Takeda Pharmaceutical (TSE:4502) [for anything in particular?]
This current quarter, Ovid plans to start a one-year extension study. This trial will give previous patients in other studies with OV101 the opportunity to receive the treatment. It will also assess long term safety and tolerability among other objectives.
Ovid’s share price made a slight increase by 1.86 percent to US$5.48 over the trading period Thursday. Earlier in the day the increase went as high as 12.15 percent.
Over the next six months, the company could see an increase to as high as US$20, according the TipRanks based off analyst reports. Tyler Van Buren with Piper Jaffray issued a “Buy” target for the company two months ago.
As mentioned, investors can look forward to hearing about updates from the long-term study as well as updates from other programs in Ovid’s pipeline.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.