Full Press Release Details
Relmada Therapeutics Licenses Phase 2 Bladder
Cancer Candidate, NDV-01, from Trigone Pharma, Ltd.
NDV-01 is a novel, sustained-release, intravesical
gemcitabine/docetaxel, ready-for-use product candidate for the treatment of non-muscle invasive bladder cancer (NMIBC, U.S. prevalence
of ~600,000 patients, with ~62,000 newly diagnosed patients annually)
Topline efficacy and safety Phase 2 data expected
to be reported at the American Urological
Association meeting (AUA), being held April 26-29, 2025 in Las Vegas
NDV-01 has the potential to be a first-line
therapy for NMIBC, presenting attractive
clinical benefits for clinicians and patients
CORAL GABLES, Fla., March 25, 2025 (GLOBE NEWSWIRE)
-- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", or "the Company"), a clinical-stage biotechnology company
committed to advancing innovative breakthrough therapies, today announced the completion of an exclusive licensing agreement with Trigone
Pharma, Ltd. (Trigone) for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) for the
treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The efficacy and safety of the NDV-01 are being evaluated in a Phase 2 study.
First data are expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas.
"We are delighted to add NDV-01 to our pipeline
as we believe it represents an exceptional value-creation opportunity for Relmada and our investors. The drug development expertise of
our Team provides flexibility to be opportunistic and consider programs that have the potential to be high-value assets and that can demonstrate
proof-of-concept in the near-term, regardless of therapeutic area. NDV-01 is an excellent fit with that profile," said Sergio Traversa,
CEO of Relmada Therapeutics.
"We believe Trigone's novel intravesicular
sustained-release formulation could enable NDV-01 to be a first-line therapy for non-muscle invasive bladder cancer, supported by several
differentiators including robust published clinical evidence with the gem/doce combination, NDV-01's good safety profile, easy dosing
procedure, and superior drug delivery profile. Together, we believe these features could enable both inpatient and outpatient clinic use,
sustained delivery out to 10 days, versus hours for conventional gem-doce delivery, and lead to NDV-01's rapid and broad adoption,"
continued Dr. Traversa.
Maged Shenouda, CFO of Relmada added, "We
believe NDV-01 is an excellent strategic complement to our recently acquired asset, sepranolone, a unique, Phase 2b-ready neurosteroid
with potential applications in the treatment of compulsion-related disorders. The addition of both NDV-01 and sepranolone to our development
portfolio achieves our principal objectives of diversifying our pipeline while balancing its risk and upside potential. Our goal is to
bring both programs to patients as soon as possible."
"There is a significant unmet need for effective
treatments for patients with non-muscle invasive bladder cancer who don't respond to BCG1 therapy," said Yair Lotan, MD,
Professor of Urology, and Chief of Urologic Oncology at UT Southwestern Medical Center at Dallas, Texas. "Based on multiple clinical
studies, the combination of gemcitabine and docetaxel has shown impressive efficacy with a manageable safety profile."
"What makes NDV-01 particularly promising
is its sustained-release formulation, securing prolonged dwell time and extensive treatment exposure to bladder tumors and enhancing anti-cancer
effects. This innovative approach has the potential not only to improve treatment effectiveness but also to improve patient compliance
by offering a convenient in-office treatment alternative to current hospital-based therapies, significantly reducing the burden on patients
and healthcare systems," said Dan Touitou, B Pharm, MBA, CEO of Trigone.
About the Clinical Program for NDV-01
NDV-01 is currently being evaluated in a Phase
2, Single-Arm Study (NCT06663137) to assess safety and efficacy in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC).
The study was designed to enroll up to 70 subjects with localized, non-metastatic, HG-NMIBC (ECOG score of 2 of less).
Topline data from the first 20 patients in the
study are expected to be presented at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas.
Relmada continues to evaluate additional strategic
product opportunities to leverage the extensive development capability that the Company has built over the past several years. Relmada
anticipates hosting an investor update on NDV-01's next development steps later in 2025.
About the NDV-01 License Agreement
Under the terms of the agreement, Relmada will
make a $3.5 million upfront payment and issue 3,017,420 shares of our common stock, which represent 10% of Relmada's outstanding
shares, for exclusive worldwide rights to NDV-01, excluding Israel, India and South Africa. (The shares will be locked up for 12 months
unless we agree otherwise.) In addition, Relmada will pay up to $200 million in development, regulatory and sales milestones pending successful
commercialization. Relmada will also pay a royalty of 3% on any net sales. Following the completion of the ongoing Phase 2 study, Relmada
will assume responsibility for NDV-01's development, manufacturing and commercialization.
NDV-01 is an investigational, innovative sustained-release
formulation of two complementary, well-established, chemotherapy agents, gemcitabine and docetaxel (gem/doce). It is designed for intravesical
dosing and intended to be an in-office ready-to-use therapy that is administered rapidly and requires no anesthesia or new or dedicated
equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequesters drug and releases it as the matrix gradually
NDV-01's formulation is specifically designed
to maximize local drug concentration and prolong exposure to gem/doce, while minimizing systemic toxicity. Unlike conventional intravesical
instillations, NDV-01 is designed to avoid peaks and troughs in drug concentration, ensuring a gradual and sustained release of gem/doce
over a 10-day period. This approach may potentially improve overall efficacy, reduce side effects, reduce the frequency of dosing and
improve patient compliance and outcomes. NDV-01 has the potential to be a first line (1L) therapy for HG-NMIBC, with further potential
for use in patients who have failed other therapies, including BCG immunotherapy, and expansion into other NMIBC subtypes, including intermediate-grade
NDV-01 is protected by several patents related
to methods of treatment and formulation whose terms go out to 2038.
About Gem/Doce in HG-NMIBC
Gemcitabine and docetaxel (Gem/Doce) therapy in
HG-NMIBC has been widely adopted in clinical practice. The highest efficacy has been demonstrated in sequential intravesical treatment
(Kates et al., 2020). A literature review suggests that there have been no major side effects reported in published studies or real-world
experience. The combination has not been approved by the FDA or EMA.
A Large and Growing Market for NMIBC Therapies
More than 90% of the approximately 83,000 new
U.S. cases of urothelial cancer are estimated to be bladder cancer. For the overall bladder cancer population, 5-year survival ranges
from 70 to 96% of patients, moving to 6% for patients with advanced disease. Roughly 75% of bladder cancer cases are classified as non-muscle
invasive (NMIBC) and approximately 50% of cases are classified as high-grade disease, considered to have increased risk of progression
and recurrence. Sources indicate that NMIBC has a 50-75% recurrence rate (over seven years) and that the U.S. prevalence of NMIBC is approximately
The US NMIBC market is estimated to be a multi-billion
opportunity. Global numbers are higher, in line with projections for significant growth due to the increasing incidence of bladder cancer
and the demand for effective, minimally invasive potential therapies like NDV-01. Approved treatment options remain limited (mainly the
immunotherapy, BCG, which has been supply constrained for some time), with high recurrence rates leading to frequent re-treatment and
progression. Other emerging programs include immunotherapy combinations, single agent chemotherapy formulations and targeted therapies.
NDV-01 stands out based on the large body of published data that support the efficacy of treatment with gemcitabine and docetaxel, its
ease of administration and potential for durability of action. Expansion beyond first-line treatment into use as a salvage treatment or
in other subgroups of NMIBC, including na ve patients, could further increase the opportunity for NDV-01.
About Trigone Pharma Ltd.
Trigone Pharma Ltd. is a privately-held specialty
pharmaceutical company focused on the development of a proprietary sustained-release platform designed to enhance the efficacy and safety
of established therapeutic agents for urologic diseases into the urinary bladder with clear unmet medical needs.
For more information, please visit https://trigonepharma.com/
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology
company committed to advancing innovative breakthrough therapies that have the potential to bring meaningful clinical benefits to targeted
patient populations.
Lead investigational program, NDV-01, for High-Grade
Non-Muscle Invasive Bladder Cancer, is being evaluated in a Phase 2 study. In addition, preparations are underway to advance sepranolone,