Reviva Pharmaceuticals Reports RP5063 Positive Efficacy Results for Memory Deficits

SANTA CLARA, Calif.–(BUSINESS WIRE)–Reviva Pharmaceuticals, Inc., a privately held drug discovery and
development company, today presented new positive preclinical efficacy
data for memory deficits at the Society for Neuroscience annual meeting
in Chicago. RP5063 reverses and prevents subchronic
phencyclidine-induced declarative memory deficits and increases cortical
dopamine efflux in C57BL/6J mice. These results indicate that RP5063,
via multi-receptor mechanisms, ameliorates subchronic declarative memory
impairment. The potential of RP5063 to delay or prevent the emergence of
cognitive impairment is suggested by the prevention paradigm. Increasing
cortical DA efflux, in the prefrontal cortex one of the regions
implicated in declarative memory, may contribute to the beneficial
effect of RP5063 in cognition. These cognition results of RP5063 are in
line with the promising efficacy signals reported in the phase 1B
clinical trial in stable schizophrenia patients and the phase 2 trial in
acute schizophrenia. RP5063 Phase 3 trials in schizophrenia measuring
cognition outcome are in preparation.

“Cognitive impairment in schizophrenia is a major unmet medical need,”
said the senior author Herbert Meltzer, M.D., Ph.D., Department of
Psychiatry and Behavioral Sciences, Feinberg School of Medicine,
Northwestern University. “RP5063 increases dopamine but not
acetylcholine or glutamate in either prefrontal cortex or striatum
areas. This action is unique: RP5063 has a novel mechanism of action and
more selective effect on cognition.”

“This preclinical cognition data reaffirm the efficacy signals for
cognition already seen in the phase 1B and phase 2 clinical trials in
schizophrenia patients and also the unique mechanism of action of
RP5063,” said Laxminarayan Bhat PhD, President and Chief Executive
Officer of Reviva Pharmaceuticals. “We are optimistic that the Phase 3
clinical trials will further establish RP5063 cognition benefit for
treating schizophrenia.”

About Schizophrenia

Schizophrenia
is a serious, lifelong mental disease whose symptoms are generally
divided into three categories – Positive, Negative, and Cognitive.
Cognitive symptoms are across multiple domains including inattention and
poor memory. Many schizophrenia patients also suffer from depression,
mood swings and some even with bipolar-like states such as
schizoaffective disorder. Current antipsychotics may help relieve the
positive symptoms of schizophrenia but their effectiveness for treating
negative and cognitive symptoms tends to be poor. Approved treatments
also have serious dose limiting side effects, including troublesome
actions on motor function (movement), weight gain, and metabolic
symptoms (diabetes and hyperlipidemia), diminished sexual function, and
sedation with many patients failing to take their prescribed medications
because of these side effects. As a consequence, few patients are able
to regain their normal psychosocial function with these currently
available pharmacological and rehabilitation treatments. Hence, there is
still a major unmet medical and public health need for safer and more
effective alternative treatments of schizophrenia.

About RP5063

RP5063 is a novel atypical antipsychotic drug (APD) with relatively
unique pharmacology. Its principal action is potent dopamine-serotonin
stabilization, the result of partial agonist properties at dopamine (DA)
D2, D3, and D4 receptors, serotonin
(5-HT) 5-HT1A and 5-HT2A, and antagonist activity
at 5-HT2B, 5-HT6 and 5-HT7 receptors.
The multi-receptor profile of RP5063 includes a number of mechanisms
which have the potential to improve cognitive impairments in
neuropsychiatric and neurological diseases, particularly partial agonism
5-HT1A and 5-HT7 receptor antagonism, and possibly
D4 partial agonism. RP5063 is an orally active new chemical
entity (NCE) having effective patent life until September 2030 with
possibility of patent term extension up to additional 5 years.

RP5063 global phase 2 clinical trial results showed a robust remission
level efficacy for acute schizophrenia in addition to promising efficacy
signals for comorbid conditions cognition impairment and mood disorders.
RP5063 showed a very good safety and tolerability profile with no weight
gain, metabolic, cardiac or movement side effects, leading to good
acceptance and compliance with the treatment. RP5063 is also under
development for the treatment of major depressive disorder, bipolar
disorder, Tourette syndrome, attention-deficit/hyperactivity disorder
(ADHD), agitation in autism, and psychosis in Alzheimer’s and
Parkinson’s diseases. Cognitive impairment is a major unmet medical need
in these neuropsychiatric and neurological diseases.

About Reviva Pharmaceuticals Inc

Reviva Pharmaceuticals Inc. (Reviva), located in Santa Clara,
California, is a clinical stage pharmaceutical company focused on
developing a portfolio of internally discovered next generation
therapies that address unmet medical need in the areas of central
nervous system (CNS) and metabolic diseases. Reviva has a strong patent
portfolio and several products in the pipeline at various stages of
development.

Reviva’s leadership team has a strong background and a track record in
successful rapid product development, regulatory approval and
commercialization. Reviva was founded in 2006 and financed by angel
investors including medical doctors, successful entrepreneurs, and
professionals associated with the pharmaceutical and high-tech
industries. For additional information, please visit our website at www.revivapharma.com.

Forward Looking Statements

This press release contains forward-looking statements made pursuant to
the “safe harbor” provisions of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements reflect management’s current
knowledge, assumptions, judgment and expectations regarding future
performance or events, they give no assurance that such expectations
will prove to be correct. Forward-looking statements are subject to a
number of risks and uncertainties, but not limited to, our liability to
obtain additional capital on acceptable terms, or at all, including
additional capital which will be necessary to complete the clinical
trials, the availability of top-line-data-delays in enrollment, delays
caused by institutional review boards or regulatory agencies, shortage
of clinical trial supplies, dependence on clinical trial collaborators,
loss of any executive officers or key personnel or consultants. Undue
reliance should be placed on forward-looking statements, which speak
only as of the date they are made, and the facts and assumptions
underlying the forward-looking statements may change. Except as required
by law, Reviva disclaims any obligation to update these forward-looking
statements to reflect future information, events or circumstances.

Contacts

Reviva Pharmaceuticals, Inc.
Laxminarayan Bhat, PhD, +1 408-816-1454
Fax:
+1 408-904.6270
President and CEO
3900 Freedom Circle, Suite
101, Santa Clara, CA 95014
busdev.rp@revivapharma.com