Partnering
Vistagen is committed to exploring long-term strategic partnerships across our pipeline that may help unlock the potential value of our CNS portfolio of product candidates.
We welcome inquires related to co-development, licensing, and commercialization of our key product candidates across neuropsychiatric, and women's health conditions and disorders - with a shared goal of advancing the development and potential commercialization of these products.
For more information on partnering with Vistagen, please contact us at busdev@vistagen.com.
Types Of Partnering Opportunities:
Co-development
Joint clinical development arrangements with shared costs and rights across pipeline candidates.
In-licensing
Regional or global development and commercial rights acquired for drug candidates.
Out-licensing
Development rights granted to partners for select drug candidates.
Commercialization
Partnerships to maximize product launch, promotion, and distribution for approved or late-stage products.
Later-Stage Selective Partnering Opportunities
In addition to the featured opportunities described above, Vistagen may selectively evaluate U.S., global, and geographic strategic arrangements, co-development, or out-licensing opportunities related to our later-stage pherine pipeline programs, where external collaboration could accelerate development or unlock additional long-term value.
These assets include:
Refisolone (PH80)
Vasomotor Symptoms (VMS) of Menopause, and Premenstrual Dysphoric Disorder (PMDD)
Other Featured Opportunities
Each program profile summarizes where the asset stands, the partnership we’re seeking, and the science behind it.
PH15 is our intranasal pherine product candidate under development for the improvement of psychomotor or cognitive impairment caused by mental fatigue.
Partnering Interest
Vistagen is currently evaluating the potential Phase 2 development path forward for PH15 and the manufacturing, nonclinical and clinical programs required to support submission of a U.S. IND to facilitate further potential development of PH15 in the U.S.
Potential Partnering Areas
- Co-development opportunities
- Regional or global licensing opportunities
Mechanism of Action
- Thought to target nasal receptors that modulate the nasal-entorhinal cortex area/hippocampus cognition neurocircuits, which are known to be associated with psychomotor activity and cognition, without requiring systemic absorption or direct action on neurons in the brain.
- Currently PH-15 is differentiated from the MOA of all currently approved treatments to improve psychomotor impairment caused by mental fatigue.
Clinical Evidence1,2
- In a randomized, double-blind, placebo-controlled, crossover Phase 2A pilot study conducted in Mexico to explore the efficacy, safety, and tolerability of intranasal administration of PH15 on psychomotor performance as measured by reaction time in sleep-deprived participants, PH15 demonstrated a statistically significant improvement in reaction time and the number of errors on both isochronous and stochastic stimuli reactions tests as compared to placebo and caffeine in the sleep-deprived study participants.
- Demonstrated favorable safety data in all clinical trials completed to date.
1 Vistagen does not yet have statistically significant data on PH15 for cognitive impairment due to mental fatigue
2 Vistagen data on file, can be shared under confidentiality
PH284 is our intranasal pherine product candidate with a novel, rapid-onset, neurocircuitry-focused proposed MOA that, we believe, is differentiated from all current treatments for the loss of appetite associated with chronic disorders, such as cancer or heart disease.
Partnering Interest
Vistagen is evaluating the potential path forward for PH284, including an assessment of the manufacturing, nonclinical and Phase 1 clinical programs required to support a U.S. IND application for potential further Phase 2 clinical development of PH284 in the U.S. for the treatment of cancer cachexia or other appetite-related disorders.
Potential Partnering Areas
- Co-development opportunities
- Regional or global licensing opportunities
Mechanism of Action
- PH284 is thought to act by modulating the nasal-limbic amygdala-hypothalamic depressed mood and appetite control neurocircuits.
Clinical Evidence2
- In a double-blind, placebo-controlled exploratory Phase 2A study in Mexico designed to evaluate the efficacy, safety, and tolerability of intranasal administration of PH284 in female patients diagnosed with cachexia (induced by chronic loss of appetite) due to terminal cancer, PH284 induced a cumulative effect on mean Subjective Feeling of Hunger (SFH) scores, as compared to placebo.
- No unusual changes in body weight were observed in either the PH284 or placebo groups, though on average, there was a small gain in body weight for PH284 versus a small loss in placebo.
- PH284 demonstrated no serious treatment-related adverse events.
- All the adverse events reported were attributed to the underlying medical condition (cancer) and were not deemed to be related to the administration of PH284 or placebo.
2 Vistagen data on file, can be shared under confidentiality
AV-101 (4-Cl-KYN) is our oral prodrug candidate that targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous neurological diseases and disorders.
Partnering Interest
Vistagen is evaluating the potential path forward for AV-101, including potential third-party collaborative manufacturing, late-stage clinical development and commercialization of AV-101 for one or more neurological disorders involving the NMDAR.
Potential Partnering Areas
- Regional or global licensing opportunities
Mechanism of Action
- The active metabolite of AV-101, 7-chloro-kynurenic acid (7-Cl-KYNA), is a potent and selective full antagonist of the glycine binding site of the NMDAR that inhibits the function of the NMDAR.
- Unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker.
Clinical & Safety Profile
- In clinical and nonclinical testing completed to date, AV-101 has demonstrated favorable oral bioavailability and pharmacokinetic results.
- No binding of AV-101 or 7-Cl-KYNA to off-site targets was identified by an extensive receptor screening study.
- In all clinical trials completed to date, AV-101 has been well-tolerated with no psychological side effects or safety concerns.
- Nonclinical results also indicate that chronic administration of 4-Cl-KYN induces hippocampal neurogenesis and increases endogenous levels of KYNA, which also is a functional NMDAR glycine site antagonist.
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