Study for hospitalized moderate to severe
cases in Kuwait terminated, while study for out-patient mild to
moderate cases continues in North America
Dr. Reddy’s Laboratories Ltd. (BSE: 500124,
NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its
subsidiaries together referred to as “Dr. Reddy’s”) and Global
Response Aid FZCO (GRA) today announced the termination of Avigan
Trial Study conducted in Kuwait focused on moderate to severe COVID
patients in a hospital setting.
The hospitalized patient study, conducted in Kuwait, on moderate
to severe patients was one of the studies in the overall clinical
program for Avigan, spanning the spectrum of Asymptomatic to severe
cases of COVID in both outpatient and in-patient setting. The
Phase-III study, being conducted in an outpatient setting on
patients with mild to moderate symptoms in North America by Dr.
Reddy’s, in partnership with Appili Therapuetics and Global
Response Aid, shall continue.
The data from the Kuwait CVD-04-CD-001 study involving
moderate-severe COVID 19 hospitalized patients did not show
statistically significant difference for the primary endpoint (i.e.
time to sustained hypoxia resolution) for Avigan vs. Placebo (7
days vs 8 days; p= >0.05). The full data analysis on 353
subjects would be available by the end of February 2021. Within
this group, there was sub group analysis carried out on 181
subjects in the low risk category. The Sub-group analysis of the
low-risk (low NEWS Score at admission) study cohort (n=181)
demonstrated a 3 day earlier discharge in Avigan group compared to
placebo group (8 days vs 11 days; p=0.0063) for time to hospital
discharge secondary endpoint. The sub group analysis data during
the initial interim analysis points towards the hypothesis with
clinically significant insights from this study that an antiviral
drug like Avigan may be effective as part of early treatment
initiation in COVID 19 patients and not effective in the late-stage
hospital treatment for moderate and severe COVID 19 patients.
Dr.Reddy’s, in partnership with Appili Therapuetics and Global
Response Aid, shall continue the Phase 3 pivotal study [PRESECO]
being conducted in North America in an out-patient setting. The
PRESECO study aims to determine the efficacy of Avigan as an early
treatment for COVID-19 patients with mild-to-moderate symptoms,
with the goal of alleviating symptoms and preventing disease
progression before the infection requires hospitalizations or other
intensive interventions. Additional observational studies to
evaluate efficacy of Avigan as part of early treatment in COVID 19
patients are also initiated.
Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Through its three
businesses - Pharmaceutical Services & Active Ingredients,
Global Generics and Proprietary Products – Dr. Reddy’s offers a
portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults, currency exchange rates, interest rates, persistency
levels and frequency / severity of insured loss events, (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no
obligation to update any information contained herein.”
About FUJIFILM Corporation, Tokyo, Japan is one of the
major operating companies of FUJIFILM Holdings Corporation. The
company brings cutting edge solutions to a broad range of global
industries by leveraging its depth of knowledge and fundamental
technologies developed in its relentless pursuit of innovation. Its
proprietary core technologies contribute to the various fields
including healthcare, graphic systems, highly functional materials,
optical devices, digital imaging and document products. These
products and services are based on its extensive portfolio of
chemical, mechanical, optical, electronic and imaging technologies.
For the year ended March 31, 2020, the company had global revenues
of $21 billion, at an exchange rate of 109 yen to the dollar.
Fujifilm is committed to responsible environmental stewardship and
good corporate citizenship. For more information, please visit:
holdings.fujifilm.com
About Global Response Aid (GRA) Agility (KSE/DFM: AGLTY),
one of the world’s leading logistics companies and AiPharma, an
innovative pharma research, development and commercialization
company based in Dubai,established Global Response Aid (GRA) to
address the market challenges created by the COVID-19 pandemic and
other threats to public health. GRA delivers innovative, effective
healthcare solutions through a range of pharmaceutical products and
technology platforms. It works closely with governments, regulatory
authorities, hospitals, clinics, healthcare providers, life
sciences companies, NGOs and public institutions to develop
strategies that allow them to tackle public health challenges. For
more information: www.globalresponseaid.com www.agility.com
About AiPharma AiPHARMA is an early-stage biotechnology
company with regional offices in Dubai and Tokyo. We take a highly
interdisciplinary approach to science, with our services building
upon work from leading academic labs in biophysics and algorithmic
design that enables the acceleration of life science research and
development in the pursuit of improved human health. For more
information: www.aipharmalab.com
About Appili Therapeutics Appili Therapeutics is an
infectious disease biopharmaceutical company that is purposefully
built, portfolio-driven, and people-focused to fulfill its mission
of solving life-threatening infections. By systematically
identifying urgent infections with unmet needs, Appili’s goal is to
strategically develop a pipeline of novel therapies to prevent
deaths and improve lives. As part of a global consortium, Appili is
sponsoring late-stage clinical trials evaluating the antiviral
Avigan® (favipiravir) for the worldwide treatment and prevention of
COVID-19. The Company is also advancing a diverse range of
anti-infectives, including a broad-spectrum antifungal, a vaccine
candidate to eliminate a serious biological weapon threat, and two
novel antibiotic programs. Led by a proven management team, Appili
is at the epicenter of the global fight against infection. For more
information, visit www.AppiliTherapeutics.com.
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135) MEDIA RELATIONS APARNA TEKURI
aparnatekuri@drreddys.com (PH: +91-40- 49002446)
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