- Company to share new positive, statistically
significant results across Cohort 4 (1050mg) from Phase 2 study of
MYMD-1 in sarcopenia, an age-related frailty disorder -
MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or
“the Company”), a clinical stage biopharmaceutical company
committed to developing novel therapies for age-related diseases,
autoimmune and inflammatory conditions, announced that it plans to
share information on the Company and its product pipeline,
including an update on recent positive phase 2 study results for
MYMD-1 in sarcopenia, at the upcoming BioFuture 2023 Meeting.
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the full release here:
https://www.businesswire.com/news/home/20231004139695/en/
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Chris Chapman, MD, president, director, and chief medical
officer at MyMD Pharmaceuticals, is scheduled to present at the
conference on October 6th, 2023, at 9:30am EST. Jenna Brager, PhD,
executive vice president of drug development at MyMD
Pharmaceuticals, is scheduled to participate in a panel discussion,
Longevity: Stopping Age-Related Disease at the Cellular Level on
October 5th, 2023, at 11:45am EST.
MyMD recently announced positive topline Phase 2 study results
in participants with sarcopenia/frailty which showed MYMD-1
demonstrated statistical significance in reducing serum levels of
TNF-α, IL-6 and sTNFR1, biomarkers common to a number of chronic
inflammatory diseases, and met all primary pharmacokinetic and
secondary safety and tolerability endpoints across multiple doses
over 28 days of treatment. New key findings from the Phase 2 study
showed that cohort 4 (1050mg) showed a reduction in TNF-α, a key
cytokine, across 28 days versus placebo (p=0.002 to 0.008).
“The scientific data clearly indicate statistical significance
across 28 days at the high dose group and we are extremely excited
about the completion of the phase 2 clinical trial,” said Dr. Chris
Chapman, MD, president, director, and chief medical officer at MyMD
Pharmaceuticals.
Continued Dr. Chapman, “We are pleased to share information
about our company and pipeline at BioFuture 2023, particularly
related to our lead candidate and next generation TNF-α inhibitor,
MYMD-1, which we believe is showing tremendous promise in
inflammatory diseases. Its potential to ease the burden of these
diseases, which affect millions of patients, caregivers and their
healthcare professionals, is what compels us to continue this
important research.”
The Company will present the clinical safety report to the FDA
with plans to seek future guidance for a Phase 3 clinical trial in
sarcopenia. If approved, MYMD-1 has the potential to be the first
drug approved by FDA for the condition, an age-related decline in
muscle mass and physical function which leads to greater risk of
hospitalization, disability, and death.
MyMD also recently announced that the U.S. Food and Drug
Administration (FDA) has accepted the Company’s Investigational New
Drug Application (IND) to evaluate the safety, efficacy,
pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor
MYMD-1® in patients with active rheumatoid arthritis (RA). Phase 2
trials are planned in RA.
MYMD-1 is an oral, next-generation TNF-α inhibitor with the
potential to transform the way TNF-α based diseases are treated due
to its selectivity and ability to cross the blood brain barrier.
Its ease of oral dosing is a significant differentiator compared to
currently available TNF-α inhibitors, all of which require delivery
by injection or infusion. MYMD-1 has also been shown to selectively
block TNF-α action where it is overactivated without preventing it
from doing its normal job of responding to routine infection. In
addition, in early clinical studies it has not been associated with
serious side effects known to occur with traditional
immunosuppressive therapies that treat inflammation.
About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage
biopharma company developing groundbreaking therapies for the
treatment of serious and debilitating autoimmune and inflammatory
diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally
available next-generation TNF-α inhibitor with the potential to
transform the way that TNF-α based diseases are treated. MYMD-1®,
with its small molecule design, improved safety profile and ability
to cross the blood brain barrier, has the promise to provide
meaningful therapeutic solutions to patients not served by current
TNF-α inhibitors and as a potential therapy for CNS-based
inflammatory and autoimmune diseases. The company has completed
Phase 2 studies of MYMD-1® for sarcopenia/frailty, as well as
early-stage trials for rheumatoid arthritis (RA), with the
potential to expand into other applications. The U.S. Food and Drug
Administration (FDA) has accepted the Company’s Investigational New
Drug Application (IND) to evaluate the safety, efficacy,
pharmacodynamics, and pharmacokinetics of oral TNF-α inhibitor
MYMD-1® in patients with active rheumatoid arthritis (RA).
MyMD’s second therapeutic candidate is Supera-CBD™, a novel,
synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times
more potent a CB2 agonist (activator) than plant-based CBD. The
U.S. Drug Enforcement Administration (DEA)’s scientific review
concluded Supera-CBD will not be considered a controlled substance
or listed chemical under the Controlled Substances Act (CSA) and
its governing regulations or require scheduling during development.
In addition to its potential role in managing addiction, anxiety,
chronic pain and seizures, Supera-CBD has also been shown to have
anti-inflammatory effects. For more information, visit
www.mymd.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release may contain forward-looking statements. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance, or achievements to be materially different from any
expected future results, performance, or achievements.
Forward-looking statements speak only as of the date they are made
and none of MyMD nor its affiliates assume any duty to update
forward-looking statements. Words such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and
other similar expressions are intended to identify these
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, without limitation: the timing
of, and MyMD’s ability to, obtain and maintain regulatory approvals
for clinical trials of MyMD’s pharmaceutical candidates; the timing
and results of MyMD’s planned clinical trials for its
pharmaceutical candidates; the amount of funds MyMD requires for
its pharmaceutical candidates; increased levels of competition;
changes in political, economic or regulatory conditions generally
and in the markets in which MyMD operates; MyMD’s ability to retain
and attract senior management and other key employees; MyMD’s
ability to quickly and effectively respond to new technological
developments; MyMD’s ability to protect its trade secrets or other
proprietary rights, operate without infringing upon the proprietary
rights of others and prevent others from infringing on MyMD’s
proprietary rights; and the impact of the COVID-19 pandemic or
similar public health emergencies on MyMD’s results of operations,
business plan and the global economy. A discussion of these and
other factors with respect to MyMD is set forth in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2022,
filed by MyMD on March 31, 2023, as may be supplemented or amended
by the Company’s Quarterly Reports on Form 10-Q. Forward-looking
statements speak only as of the date they are made and MyMD
disclaims any intention or obligation to revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20231004139695/en/
Investors: Robert Schatz (646) 421-9523
rschatz@mymd.com
Media: Andrea Cohen Sam Brown, Inc. (917) 209 7163
andreacohen@sambrown.com
MyMD Pharmaceuticals (NASDAQ:MYMD)
過去 株価チャート
から 5 2024 まで 6 2024
MyMD Pharmaceuticals (NASDAQ:MYMD)
過去 株価チャート
から 6 2023 まで 6 2024