PharmaShots Interview: BioCorRx' Brady Granier Shares Insights on the New Agreement with Recro to Support BICX104
In an interview with PharmaShots, Brady Granier, CEO, President, and Director at BioCorRx shared his views on the companies existing collaboration & expands with the signing of a new development and manufacturing agreement to support BICX104 for opioid use disorder
Shots:
- The companies have expanded an ongoing collaboration by signing a new development and manufacturing agreement to support BICX104 for opioid use disorder. This agreement expands the previous signed master services agreement b/w BioCorRx & IriSys
- Recro will offer analytical validation services and cGMP manufacturing of registrational batches to support BioCorRx's NDA for BICX104 with the US FDA
- BICX104 is a biodegradable, long-acting SC pellet of naltrexone for OUD which is being developed under BioCorRx. Additionally, BioCorRx has received the US FDA's clearance to move into human trials for BICX104 and is expected to start the first-in-human clinical trial shortly
Tuba: Can you please share a brief description of the BICX104 naltrexone pellet?
Brady: BICX104 is a one-gram pellet of nearly pure naltrexone about the size of the tip of one's pinky finger. It is subcutaneously implanted in the belly flat and should dissolve over three months. It is currently being studied and developed to address both opioid and alcohol use disorders.
Tuba: How will this drug help people to overcome their addiction?
Brady: Once implanted, naltrexone, a drug that has been FDA-approved for many years, is released in the body and reaches the brain where it blocks the same receptors that opioids bind to. It's designed to do this for a few months, thereby blocking the effects, as well as the cravings, for these substances. Naltrexone is a proven treatment and our pellet is a new delivery method aimed at aiding patient adherence to treatment.
Tuba: Can we take a quick look at the BICX104 study design for P-I?
Tuba: Highlight BioCorRx's agreement with Recro pharma. How will it be helpful in the advancement of BICX104?
Brady: IRISYS, a company now owned by Recro Pharma, has been our R&D manufacturing partner since the early stages of the program. We have engaged with them to expand that relationship to clinical and commercial batch manufacturing. With Recro recently acquiring IRISYS, we feel it brings an added level of support and expertise to the overall project.
Tuba: Are there any other indications BioCorRx is accessing with BICX104?
Brady: We have guidance from the FDA via our initial Pre-IND meeting that we can use the data to seek approval for alcohol use disorder as well. There could be other indications in the future.
Tuba: Are there any other products in the BioCorRx pipeline?
Brady: We are always evaluating other products but they would be very early stage and as a small company, our main objective is to get this potentially life-saving product, BICX104, on the market.
Tuba: Can we discuss the fund that BioCorRx received from NIDA? What more are you expecting from such authorities for the development of BICX104?
Brady: We have been very grateful for the support from NIH/NIDA over the years. They have been great partners and continue to be great partners. This is a very important project for them and the general public. We recently received an additional $3.4 million to support the project for a total of nearly $9.2 million to date and we are currently accessing what other needs we may have as we progress.
Tuba: Tell us more about the statistical data of people in the US who are addicted to drugs or alcohol/the people suffering from substance use disorders.
Brady: According to the National Institute for Drug Abuse (NIDA), drug overdoses have spiked almost 30 percent during the coronavirus pandemic
A study from the National Institute on Drug Abuse found that the relapse rate for those with substance abuse issues ranges from 40 to 60 percent.
More than 93,000 Americans died from drug overdoses in 2020, the highest number on record, according to the Centers for Disease Control and Prevention (CDC). Fentanyl was involved in more than 60% of those overdoses deaths last year. The estimate of over 93,000 translates to an average of more than 250 deaths each day, or roughly 11 every hour.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has stated that U.S. adults bought more alcohol during most months of 2020 than the previous 3 years.
Tuba: In comparison with other therapies that exist in the market for substance use disorders, how is BICX104 unique?
Brady: BICX104 is unique because it fills a current void in the currently available FDA-approved opioid antagonist treatments. Naltrexone is effective for opioid use disorder and other indications which is unique to other forms of medication-assisted treatment and it also doesn't involve withdrawals once discontinued. When looking at strictly naltrexone products, it is unique in that it's designed to last multiple months after one administration, however, it can be removed if required for any reason. Another characteristic, although not unique, is that it completely degrades over time and is absorbed by the body.
Brady Granier is the CEO, President, and Director of BioCorRx. He has 9 years of combined experience in the Healthcare and Behavioral Health Field & earned his Bachelor of Science Degree in Nursing in 1995 and was a member of Sigma Theta Tau Honor Society and Phi Kappa Theta. Mr. Granier specialized in the critical care areas of ER/ICU/CCU and CICU. He has 9 years of combined experience in the Healthcare and Behavioral Health Field
Source: Nursing in Practice
About Author: Brady Granier is the CEO, President, and Director of BioCorRx. He has 9 years of combined experience in the Healthcare and Behavioral Health Field. Mr. Granier earned his Bachelor of Science Degree in Nursing in 1995 and was a member of Sigma Theta Tau Honor Society and Phi Kappa Theta. Mr. Granier specialized in the critical care areas of ER/ICU/CCU and CICU
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