The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is charging higher on Friday.
In early afternoon trade the biopharmaceutical company’s shares are up a sizeable 6% to $2.55.
Why is the Paradigm share price charging higher today?
Investors have been fighting to get hold of Paradigm’s shares on Friday after the release of an announcement this morning.
According to the release, Paradigm has submitted its Investigational New Drug (IND) application to the US Food and Drug Administration (FDA). This is for the planned pivotal study and extension study with PPS (Zilosul) for the treatment of patients with Knee Osteoarthritis (OA). The company believes the submission of its IND application marks a significant milestone.
Management revealed that in preparation for the IND submission and commencement of the pivotal clinical program, Paradigm conducted meetings with key regulatory bodies. This was to ensure the clinical trial design would be acceptable on a global platform and meet all obligations required for registration upon successful trial results.
One of these was a pre-IND meeting in February last year with the FDA. At this meeting the two parties discussed the clinical trial protocol. Paradigm also received feedback from a Type-C meeting in December 2020, where the written response to questions posed by Paradigm was received from the FDA on the proposed clinical trial design.
In Europe, regulatory engagement with the EMA was also achieved via a virtual Scientific Advice meeting in September 2020.
Management commentary
Paradigm’s Chairman and CEO, Paul Rennie, commented: “It has been incredibly pleasing watching all modules of the IND submission come together and I am very thankful for the highly experienced and skilled Paradigm team for achieving this significant milestone on time for all of our stakeholders.”
“We believe that a harmonised clinical trial program that satisfies the requirements for registration with multiple global regulatory agencies will save Paradigm time and money as we approach registration and commercialisation of Zilosul.”
Mr Rennie also believes that the IND will give the company’s profile a boost and bring it into the radar of investors and potential partners.
“We anticipate the IND opening will provide further exposure to global investors and partners with the company already receiving an increase in global interest in our Phase 3 clinical program during our attendance this week at the 2021 BIO-Europe Spring Partnering conference where the company has participated in several partnering meetings.”
“We look forward to providing further detail on the final study design and timing once the IND has been opened following the 30-day review period with the FDA.”
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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.
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