VTGN - Vistagen Poised To Begin Phase 1 Trial Of A Fast-Acting Antidepressant Nasal Spray In First Quarter Of 2023
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By Rachael Green,Benzinga
In therace to create faster-acting, safer antidepressants, Vistagen (NASDAQ: VTGN) is starting the year strong as it gets ready to launcha Phase 1 Trial of its novel pherine nasal spray for Major DepressiveDisorder (MDD). The trial, involving the Company’s newly optimizedformulation of PH10, is intended to confirm the favorable safetyprofile of PH10 established in three previous clinical studiesconducted in Mexico, including a published Phase 2A study for thetreatment of MDD. After receiving a “study may proceed” letterfrom the U.S. Food and Drug Administration (FDA) last Novemberfollowed by a Fast-Track designation from the FDA in December, thelate clinical-stage biopharmaceutical company is ready to start thePhase 1 trial in the first quarter of 2023.
Upcoming Phase 1 Clinical Trial Will Prepare Vistagen’s DrugCandidate PH10 for Phase 2B Research
On November 30, Vistagen announced that it had received a “study may proceed” letter from the FDA forPH10 as a treatment for MDD. The following week, the FDA granted Fast-Track designation to the pherine-based nasal spray. The FDA’s fasttrack program , meant to bring promising new treatments forserious conditions to patients sooner, makes Vistagen’s drugeligible for more frequent meetings and communications with the FDA– which can help ensure a smoother development and review processand, potentially, an earlier drug approval date.
The FDA’s decision togrant Fast-Track designation was based on Vistagen’s previouspreclinical and clinical research on PH10. In an earlier Phase2A study of PH10, for example, the MDD treatment was found tosignificantly reduce depressive symptoms in participants after onlyone week of treatment and at the eight-week study endpoint.
The upcoming Phase 1study will enroll 12 participants in a double-blind,placebo-controlled clinical trial with topline data expected by theend of the first quarter. The goal of the study is to confirm thefavorable safety data demonstrated in earlier clinical trials and laythe groundwork for a Phase 2B study of PH10 in MDD.
On December 21, Vistagenannounced its acquisition of Pherin Pharmaceuticals, a clinical-stage company developing apipeline of pherine drug candidates. The acquisition will giveVistagen full ownership of the intellectual property rights for bothPH10 and its Phase 3 pherine drug candidate, PH94B, allowing thecompany to stop paying royalties and milestone payments for thecompounds. The deal will also add three new pherine drug candidates toVistagen’s pipeline.
PH10 IsDesigned To Be A Fast-Acting Antidepressant With Minimal SideEffects
In thepast few years, research activity in the MDD space has picked upsignificantly as companies explore several new treatment options withdifferent mechanisms of action. That’s because the currentlyapproved antidepressants aren’t working for millions of people,leaving a massive unmet need that drug developers are racing to fill.
“Nearlytwo-thirds of diagnosed and treated depression patients do not achieveremission with first-line therapy. With 21 million adults in the U.S.suffering at least one major depressive episode in the past year,potentially millions of individuals are not getting the help theyneed,” said Vistagen CEO Shawn Singh in a statement about the upcoming Phase 1 trial for the MDD treatment.
While some excitingprogress has been made, Vistagen hopes its drug candidate, PH10, canaddress some of the shortcomings of the latest alternatives to hit themarket. PH10 is one of two pherine nasal sprays currently indevelopment at Vistagen. Pherines are a new class of synthetic chemosensory messenger drug candidatesthat may be able to provide fast-acting relief for depression andanxiety symptoms and several other unmet medical needs.
For the treatment ofdepression, PH10 is designed to activate chemosensory neurons in thenose that can then activate the limbic system, the areas of the braininvolved in emotional response. Researchers hypothesize that it doesthis possibly by triggering the release of more dopamine, serotonin,and norepinephrine, three hormones that play a role in mood andhappiness.
Thismechanism of action sets it apart from other drugs in development fordepression. COMPASS Pathways, PLC (NASDAQ: CMPS), for example,is working on COMP 360 – a psilocybin-based therapy fortreatment-resistant depression – which has shown promise in recentclinical trials. In one Phase 2b study, a single high dose of thepsilocybin compound was able to provide immediate symptom improvementwith results lasting up to 12 weeks.
However, being a psychedelic, the treatmentrequires psychological support from a specialty-trained therapistduring a psilocybin therapy session. While it may be helpful in thelong run, the time-consuming process isn’t as convenient as astandalone medication that could be taken daily or as needed withoutinterrupting the rest of the day.
Meanwhile, Relmada Therapeutics, Inc. (NASDAQ: RLMD) is developing REL-1017, a compound that works byblocking the N-Methyl-D-aspartate (NMDA) receptor in the brain. Thedaily oral treatment is meant to work similarly to ketamine-derivedtreatments like Johnson & Johnson’s (NYSE: JNJ) recentlyapproved Spravato, but without the psychotropic effects.
However, the late-stagebiotech announced top-line results from its Phase 3 trial of the drugcandidate last October, noting that it failed to achieve its primaryendpoint of significantly reducing depression symptoms compared to aplacebo.
PH10, onthe other hand, does not require the same systemic uptake to produceits fast-acting effects, according to Vistagen. The compound doesn’tcause the same psychotropic side effects as ketamine-based treatmentsbut has still managed to demonstrate rapid-onset and significantlasting results in the clinical studies completed so far. As trialsprogress, it could be worth keeping on the company as it leverages itsrecent wins to bring its drug to market quickly for the millionssuffering from depression.
This article was originally published onBenzinga here.
Vistagen (Nasdaq: VTGN) is a lateclinical-stage biopharmaceutical company aiming to transform thetreatment landscape for individuals living with anxiety, depressionand other CNS disorders. The Company is advancing therapeutics withthe potential to be faster-acting, and with fewer side effects andsafety concerns, than those that are currently available. Vistagen’sclinical-stage candidates are targeting multiple forms of anxiety anddepression. PH94B and PH10 belong to a new class of drugs known aspherines, which are investigational neuroactive steroid nasal spraysdesigned with a novel rapid-onset mechanism of action that activateschemosensory neurons in the nasal passages and can impact theolfactory-amygdala neural circuits without systemic uptake or directactivity on CNS neurons in the brain. Vistagen is passionate abouttransforming mental health care and redefining what is possible in thetreatment of anxiety and depression.
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