NetworkNewsWire
Editorial Coverage: Big pharma and life science companies are
making big news these days. The drug-development space is seeing
strong investor interest as these companies make breakthrough
advancements that address vast unmet medical needs. Strategic
M&A moves are adding spice to the gumbo for investors as
pioneering research remains focused on providing life-changing
treatments for those suffering from a myriad of disorders. One of
the largest and trickiest medical disorders of mankind may be on
the cusp of more effective treatment. Depression is often kept in
the dark and not talked about, but it is estimated that more than 17
million adults in the United States experienced at least one
major depressive episode in 2019 alone, while one out of every four
people in the world struggle with a diagnosable mental disorder.
Life sciences company Cybin
Inc. (Cybin Profile) is at the vanguard of new
therapeutic protocols that target these disorders. Cybin is intent
on developing psychedelic therapeutics along with unique delivery
mechanisms that target depression as well as other psychiatric and
neurological conditions. The company could benefit from two
game-changing announcements made in the past few days: the company
just completed its
previously announced reverse takeover and a groundbreaking
study published in JAMA Psychiatry reports that in a
recent study a treatment featuring psilocybin actually worked
better than typical antidepressant medications. Other
drug-development companies are experiencing similar milestone
moments. Last month Praxis
Precision Medicines Inc. (NASDAQ: PRAX) closed on
its upsized initial public offering of 11,500,000 shares of common
stock, resulting in aggregate gross proceeds to Praxis of $218.5
million. Earlier this year, AbbVie
Inc. (NYSE: ABBV) completed a transformative
acquisition of Allergan. Less than a year ago, Axsome
Therapeutics (NASDAQ: AXSM) realized more than $200
million when it closed on its public offering. And this summer
Relmada
Therapeutics Inc. (NASDAQ: RLMD) uplisted to
trade on the Nasdaq Global Select Market.
- Cybin’s reverse takeover creates new publicly traded company
focused on development of psychedelic therapeutics targeting
neurological, psychiatric conditions.
- Recent research observed that psilocybin treatment had “more
than four times greater effect” than usual antidepressant
medications.
- Cybin R&D pipeline includes multiple studies and
trials.
Click here to view
the custom infographic of the Cybin editorial.
Focused on Breakthrough Psilocybin
Therapeutics
Staggering amounts of big money are moving into the
drug-development sector, and Cybin Inc. is
seeing its share. The leading life sciences company recently
announced that it completed a reverse takeover transaction
announced last month; the company also expects to start trading
common shares on the NEO exchange as soon as week under the symbol
CYBN.
According to Cybin, the reverse takeover of Clarmin Explorations
Inc. will result in a unique public company. The new company will
focus on psychedelic drug development, unique delivery mechanisms,
and improved novel compounds and protocols that may finally offer
relief to the millions that suffer from depression and other
psychiatric or neurological conditions.
“We are very pleased to have completed the Reverse Takeover and
to have received conditional approval to list CYBIN’s shares on the
NEO Exchange,” said Cybin CEO Doug Drysdale. “We anticipate it will
help us to enhance our visibility within the investment community
and broaden our investor base, with the goal of building long-term
shareholder value. It also represents an important step forward in
advancing our development plans. We believe in the application of
psychedelic therapies and look forward to advancing them and our
other product candidates.”
In addition, Cybin Inc. previously announced the closing of a
private placement offering resulting in aggregate gross proceeds of
CDN$45 million. Cybin plans to use the net proceeds from this
offering to further develop the company’s psychedelic therapies and
nutraceutical products, as well as for working capital and general
corporate purposes. The offering included participation from
several new investors including RA Capital Management, Janus
Henderson Investors, Kearny Venture Partners, LifeSci Venture
Partners and Bail Capital.
Effect ‘More than Four Times Greater’
In a world where one out of every
four people struggle with a diagnosable mental disorder, people
are desperately searching for answers. Cybin is working to identify
answers and address an enormous unmet medical need. The company is
intent on becoming the first life sciences company to bring an
effective psilocybin therapeutic drug to market targeting major
depressive disorder (MDD), and a recent study may indicate that
Cybin’s focus is spot on.
Earlier this month, an article in the journal JAMA
Psychiatry reported the remarkable findings of a study
featuring the hallucinogen psilocybin. During the study, 27
patients received two doses of psilocybin on different days and
also received about 11 hours of psychotherapy; half the
participants began treatment immediately while the other half began
treatment eight weeks later. The research team observed that the
treatment had an effect “more than four
times greater” than the typical antidepressant medications.
"There was a significant reduction in depression in the
immediate-treatment group compared to those in the waitlist,"
reported Alan Davis, an author of the study and a faculty member at
both Johns Hopkins University and Ohio State University in an NPR
article titled “Rigorous Study Backs a Psychedelic Treatment for
Major Depression.”
"The effect happened within one day after the first session and
sustained at that reduced level through the second psilocybin
session all the way up to the one-month follow-up," Davis
continued.
“The study is notable for its scientific rigor,” said Charles F.
Reynolds III, MD, distinguished professor emeritus of
psychiatry at the University of Pittsburgh's School of Medicine.
“It offers, I think, a good deal of promise as a feasible approach
to treating particularly chronic forms of depression." Reynolds
also observed that the emergence of treatments such as psilocybin
may signal a new era in treatments.
At the Vanguard of Research
The JAMA report noted that additional research and
study on all aspects psilocybin is warranted, and Cybin has already
made significant strides. Earlier this year, Cybin entered into a
feasibility
agreement with IntelGenx Corp. for the development of an orally
dissolving film for the delivery of pharmaceutical-grade
psilocybin. This could become a groundbreaking advancement not just
for the delivery psilocybin therapeutics but also for more
effective treatments of mental disorders.
“Compared to oral psilocybin capsules, which are subject to
variable intestinal absorption and high first-pass metabolism in
the liver, the systemic bioavailability of orally dissolving
psilocybin film is expected to be quite high,” said Cybin chief
medical officer, Jukka Karjalainen MD. “Additionally, the dose of
psilocybin administered by an orally dissolving film is expected to
be a fraction of the requirement in oral capsules. These features
have the potential to increase both the safety and efficacy of
psilocybin when administered in this manner.”
As part of that agreement, Cybin is currently involved in an
oral-film bioequivalence study designed to compare molecular
delivery of psilocybin through its fast-acting oral films in
contrast to capsules. This is just one of the several clinical trials and
studies in the company’s rapidly growing pipeline.
The Cybin pipeline also includes:
- A phase 2a and phase 2b clinical trial to fast track drug
approval targeting Major Depressive Disorder (MDD).
- A clinical safety and efficacy study targeting microdosing that
may lead to a clinical trial for anxiety, ADHD and overall
cognitive flexibility
- A phase 2 clinical trial targeting addition through the
delivery of psilocybin through an oral film, with further studies
leveraging a transdermal, “slow-dose” delivery mechanism.
Mental disorders have long been misunderstood, attributed to
possession by evil or to personal shortcomings comings. Science has
debunked the stigmas and revealed that typically a chemical
imbalance occurs in the brain. The progress in therapeutics has
come a long way from exorcisms and shamans yet millions still
suffer. New therapeutics are coming that may well provide relief to
the suffering and opportunity to the savvy.
Smart Players Attracting Attention
Cybin isn’t the only company making headway in this area. Other
smart players are seizing opportunities to attract investors and
strengthen their position in the space.
Praxis
Precision Medicines Inc. (NASDAQ: PRAX) closed on its
upsized initial public offering of 11,500,000 shares of common
stock. The clinical-stage biopharmaceutical company translates
genetic insights into the development of therapies for central
nervous system (CNS) disorders characterized by neuronal imbalance.
The shares began trading on the Nasdaq Global Select Market
on Oct. 16, 2020, under the ticker symbol PRAX. Praxis has
established a broad portfolio, including five disclosed programs
across multiple CNS disorders including depression, epilepsy,
movement disorders and pain syndromes.
AbbVie
Inc. (NYSE: ABBV), a research-based global
biopharmaceutical company, announced today that it has completed its
acquisition of Allergan plc following receipt of regulatory
approval from all required authorities. The acquisition creates
biopharmaceutical company with leadership positions in five key
therapeutic areas: immunology, hematologic oncology, neuroscience
and Allergan aesthetics. The new company will have a robust
portfolio of on-market and pipeline assets well-positioned for
sustainable long-term growth.
Axsome
Therapeutics (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of CNS disorders, closed its
underwritten public offering of 2,300,000 shares of common
stock for $87 per share. Axsome’s core CNS product candidate
portfolio includes four clinical-stage candidates, including one —
AXS-05 — that is currently in a phase 3 trial and is being
developed for MDD. “Over the past several months, we continued to
advance our AXS-05 and AXS-07 product candidates towards NDA
submissions in major depressive disorder and migraine, and
intensified our commercial launch readiness activities,” reported Axsom CEO Herriot Tabuteau, MD.
Relmada
Therapeutics Inc. (NASDAQ: RLMD) started trading in July
2020 on the Nasdaq Global Select Market. A clinical-stage
company developing novel therapies for the treatment of CNS
diseases, Relmada has a lead program focused on REL-1017
(dextromethadone), an N-methyl-D-aspartate (NMDA) receptor
antagonist in development for the treatment of
depression. NMDA receptor antagonists may have utility in the
treatment of a range of psychiatric and neurological disorders
associated with a variety of cognitive, neurological and behavioral
symptoms.
With drug development capturing significant investor interest
and support, the timing couldn’t be better for companies intent on
making a difference in the lives of millions of people who suffer
from mental disorders.
For more information about Cybin, please visit Cybin Inc.
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