From a business perspective, Ovid Therapeutics is walking faraway from its lead candidate OV101 in Angelman syndrome in quality form, with a long coins runway way to a deal with Takeda signed months in advance.
But that doesn’t suggest it became easy for CEO Jeremy Levin to abandon the as soon as promising medicine.
“It’s heart-rending. You have groups right here. You link to and also you recognize the households. You recognize what it method to them,” he stated in an interview. “They have many anecdotes about how the drug helped them, but you ought to look at statistics.”
And the ones statistics were not properly.
Even after accumulating tremendous evidence in a mixed bag of a section 2 trial and growing new endpoints particular to Angelman syndrome, OV101 failed to beat placebo in a past due-stage observe. Angelman syndrome reasons some of neurological symptoms various in severity which includes seizures, hassle snoozing and problems with motion or stability.
“I agree with very firmly: You both are going to essentially trade their lives with the drug, or you’re no longer,” Levin stated. “And in case you’re not going to try this, and you’ve got the resources to do some thing else … it is fine to make investments that money accurately then in other regions.”
Which brings this story to the financing. Ovid exceeded the rights to a drug called soticlestat returned to Takeda in March following a development settlement among the 2 groups that noticed the epilepsy remedy flow correctly through section 2. Closing of the deal netted Ovid $196 million upfront and a further $660 million in milestone payments further down the street.
“Financing became eliminated from the table,” Levin said, which allowed the organisation to reduce its losses on OV101 and shift cognizance to earlier pipeline assets.
RELATED: After farming an epilepsy med out to Ovid, Takeda brings it lower back into the fold
Ovid’s work to define clinical endpoints for Angelman syndrome for the duration of that sick-fated section 2 became no longer in useless. Once the FDA gave the desires a thumbs-up, at least 14 other companies started out shifting capsules into the pipeline for the sickness.
Levin and his group will stay in the sport, too, because the agency had “quietly and without an excessive amount of fuss” built up an early level pipeline of genetically targeted CNS capsules, such as one for Angelman syndrome.
“We felt everything we had learned about the field of CNS is that it’s going to explode. It’s at a cusp,” Levin said, likening it to immuno-oncology a decade ago. “We’re seeing the same pivot today in neurosciences.”
Ovid expects to be a leading neuroscience company in that race, with plans to file for three INDs over the next three years. Shortly after announcing plans to drop OV101, the company also said renowned Massachusetts Institute of Technology Professor Robert Langer, Sc.D., would be joining the scientific advisory board. The arrangement had been in the works for weeks.
Levin said the company was looking for advisers who understood the fundamental science and were “bold enough” to tackle neuroscience and ask difficult questions along the way. Langer is a legend at MIT, where he researches drug delivery methods, biotechnology and immobilized enzymes. He was the perfect fit for Ovid’s next act and agrees with Levin on where neuroscience is heading.
“The neurosciences are on the cusp of a scientific and, hopefully, therapeutic revolution. Ovid has an exciting approach to tackling the key questions that drive scientific research and new medicines in the central nervous system,” Langer said in a statement. “I am delighted to lead their scientific advisory board and look forward to helping drive advances in this important area.”
Levin and his group will stay in the sport, too, because the agency had “quietly and without an excessive amount of fuss” built up an early level pipeline of genetically targeted CNS capsules, such as one for Angelman syndrome.
RELATED: Ovid dumps lead program after lackluster showing in Angelman syndrome
Levin also has an aggressive business development plan—using that Takeda cash—that could bring in some new targets, companies or other deals.
“We’re very active. We’re looking very aggressively, very thoughtfully,” Levin said. “The question is, what matches the skills of the company and the mission, which is neurosciences?”
The original Takeda deal itself was strange, with the larger company actually licensing out development of a drug to the smaller one. These deals tend to be the other way around. Levin said “quite a number” of other large companies have come knocking asking about similar arrangements with assets they are stumped on.
