Durham’s Mycovia Pharma extends clinical trial of anti-fungal drug for yeast infections

WRAL TechWire | February 11, 2020

Mycovia Pharmaceuticals, a developer of drugs in women’s health, has initiated “extension studies” as part of its ongoing Phase 3 global clinical trial of its lead drug candidate for treating recurrent yeast infections in women. The Durham-based firm is developing oteseconazole (VT-1161), an oral antifungal product candidate, for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwide each year and for which there is currently no approved treatment in the United States. “We are delighted by the progress we’re making with our oteseconazole clinical program, including the VIOLET trials,” said Stephen Brand, PhD, senior vice president of Clinical Development at Mycovia, in a statement. “The addition of an extension component to these studies will enable us to further evaluate the long-term effectiveness of oteseconazole in preventing recurrent episodes of vulvovaginal candidiasis in women who remain disease-free at their last scheduled study visit at Week 48.”

Spotlight

November is Diabetes Awareness Month! November 14th marks the birthday of insulin co-discoverer Dr. Frederick Banting and is recognized globally as World Diabetes Day. It is an excellent opportunity to raise awareness about diabetes, a disease that is approaching epidemic proportions globally. Over 100 million Americans are diabetic or prediabetic. 9.4% of the U.S population has diabetes. Almost 25% of people living with diabetes will not even know they are sick.

Spotlight

November is Diabetes Awareness Month! November 14th marks the birthday of insulin co-discoverer Dr. Frederick Banting and is recognized globally as World Diabetes Day. It is an excellent opportunity to raise awareness about diabetes, a disease that is approaching epidemic proportions globally. Over 100 million Americans are diabetic or prediabetic. 9.4% of the U.S population has diabetes. Almost 25% of people living with diabetes will not even know they are sick.

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BUSINESS INSIGHTS

AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. The FDA clearance marks the company's transition into a clinical stage company. In addition to AM3101, the company's pipeline also includes AM1101, which is being developed for osteoarthritis, and AM2101, with an indication to treat degenerative disc disease. "We are very proud to announce the clearance for AM3101. Despite their commonality, service men and women have limited treatment options for acute meniscal tears. While suturing is often the most frequent approach, the failure rate for surgery is quite high due to the limited reparative capacity of much of the tissue. Our research has found that our Active Pharmaceutical Ingredient (API) provides pain relief and promotes regeneration of the meniscus, as well as several other structurally related joint tissues. In this way, the transition of Amplicore into a clinical stage company represents a critical development for all patients suffering from musculoskeletal conditions." Chief Executive Officer/Founder Dr. James Lin Amplicore also announced the addition of Steve Schrader to its advisory board. A high-impact financial leader with three decades of experience in corporate finance, Schrader has held Chief Financial Officer positions in a variety of industries, including an international auto glass company, a private healthcare company, a Fortune 500 public utility, and a NASDAQ-listed startup. Throughout his career, Steve has increased revenue and raised over $1.3 Billion in capital for companies. He has also taken two firms from start-up to manufacturing. Schrader will advise on financial planning and fundraising efforts. "Amplicore is a leader in developing injectable therapeutics for musculoskeletal disorders. I am excited to join the board during this pivotal time as they work to close their Series A investment round, and I look forward to being a part of their future success." ABOUT AMPLICORE, INC. Amplicore, Inc. is an early-stage biotech start-up company based on technology developed in the laboratory of CEO/Founder Dr. Chia-Ying Lin at the University of Cincinnati. Headquartered in Mason, OH, the company is dedicated to developing novel injectable therapeutics to serve unmet medical needs for degenerative musculoskeletal disorders. Unlike current therapies that focus solely on palliative treatment, Amplicore is also taking a regenerative approach to treating these disorders. The company's lead products, AM3101, AM1101, and AM2101, address significant deficiencies in the current standard of care for the treatment of acute meniscal tear, osteoarthritis, and degenerative disc disease, respectively. Amplicore's overall mission is to translate scientific innovation into effective but minimally invasive products that can be easily delivered to patients.

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PHARMA TECH

Specifica Announces Antibody Discovery Platform Transfer Agreement with Sanofi

Specifica | June 03, 2022

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody libraries and discovery tools, announced an agreement with the global healthcare company Sanofi under which Specifica’s patented Generation 3 Antibody Discovery Platform will be transferred to Sanofi. The comprehensive technology transfer package will enable the integration of Specifica’s Gen 3 platform into Sanofi’s antibody discovery programs. “We are absolutely delighted to partner with Sanofi and their cutting-edge antibody discovery teams by providing our complete antibody discovery platform through a combination of Gen 3 libraries, antibody optimization solutions, and integrated discovery tools. We look forward to the realization of our collaboration with Sanofi as they continue to pursue the development of life-changing treatments.” Ken Sharples, CEO and co-founder of Specifica Specifica’s Gen 3 libraries combine clinically validated antibody frameworks with compatible binding loop sequences (CDRs) from natural human antibodies that have been purged of sequence-based developability liabilities. The Gen 3 discovery platform consistently yields a broad diversity of specific and developable antibodies with very high affinities, thereby avoiding downstream hit-to-lead optimization bottlenecks such as affinity maturation and developability optimization. About Specifica Specifica is a rapidly growing antibody engineering company specializing in the creation of exceptional antibody libraries, using next-generation sequencing for quality control at all steps of construction and validation. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies directly from selections, minimizing the need for downstream affinity and biophysical engineering. Specifica provides its partners with exclusive libraries, each created from a unique donor diversity set not used for any other library, ensuring that each Gen 3 library is one of a kind. Specifica offers antibody library platforms in Fab, scFv and VHH formats. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery and optimization campaigns, or by full transfer of the platform technology. Additionally, Specifica recently introduced AbXtractTM, a powerful suite of antibody informatics tools, through its software partner OpenEye. Specifica is headquartered in Santa Fe, New Mexico

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BUSINESS INSIGHTS

Simulations Plus Collaborates with Multinational Pharmaceutical Company to Provide Modeling & Simulation Support for COVID-19 Treatment

Simulations Plus, Inc | June 24, 2022

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its Cognigen division worked with a major pharmaceutical company to implement modeling and simulation activities to support the development of a candidate COVID-19 therapy. This modeling and simulation work provided significant contributions towards regulatory submissions for the compound. Early in the COVID-19 pandemic, the pharmaceutical company initiated a collaboration to support the accelerated development of their compound. Together with scientists from the company, Sébastien Bihorel, Pharm.D., Ph.D., Senior Director of Pharmacometrics and Workflow Automation, led this cooperative team effort on behalf of Simulations Plus. Cognigen scientists provided real-time data processing and analysis, allowing for rapid knowledge updates about pharmacokinetics and efficacy in patients with COVID‑19 as the clinical trials proceeded. “We are extremely proud of this collaboration, which further underscores the importance and critical role of modeling and simulation in informing development-related decisions and improving the efficiency of drug development,” Jill Fiedler-Kelly, Cognigen division president About Simulations Plus Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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