- Complete up to 3 cohorts in Part 1 of 501 trial
- Explore commercial manufacturing scale-up
- Develop superiority study for IkT-001Pro relative to standard-of-care in CML
Grab sources here: Company Website - Company Presentation
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And as I mentioned above, IKT has multiple potential catalysts to soak in right now. Check them out:
No. 1 IKT Potential Catalyst - FDA Ruling Paves Way For IKT To Move Forward With Key Clinical Trial
Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
- Advancing model studies of IkT-148009 in MSA; early data has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009 –
- MSA IND Opened, the 5th in the Company's history –
- Advancing model studies of IkT-148009 in MSA; early data has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009 –
- MSA IND Opened, the 5th in the Company's history –
- Planned Phase 2a '202' clinical trial will evaluate therapeutic benefit of IkT-148009 over 6 months –
BOSTON and ATLANTA, March 8, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration ("FDA" or "Agency") has lifted the full Clinical Hold on IkT-148009, the Company's c-Abl inhibitor, in Multiple System Atrophy (MSA) allowing the Company to proceed with its plans for a future Phase 2 clinical trial in MSA.
"We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in MSA," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "As with our work in Parkinson's, preclinical models have highlighted the therapeutic potential of IkT-148009 in MSA. One of two ongoing model studies has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009. With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population."
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The planned '202' trial will evaluate the safety, tolerability and pharmacokinetics of IkT-148009 in MSA patients over 6 months of once daily dosing at one of two oral doses. Secondary and exploratory endpoints will evaluate clinical benefit using a modification of the Total Unified MSA Rating Scale (UMSARS), assessment of quality of life. severity of symptoms arising from orthostatic hypotension, and the levels of neurofilament light chain in peripheral blood and spinal fluid. Additionally, biomarkers of treatment benefit will be explored by measuring levels of phosphorylated alpha-synuclein in spinal fluid, peripheral blood and skin. Clinical effect on the progression of atrophy will be monitored in the trial using MRI.
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Read the full article here.
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No. 2 IKT Potential Catalyst - A Low Float Could Set The Stage For Major Volatility
According to the Yahoo Finance website, IKT has a low float.
The website reports this profile to have approximately 18.48Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
Could positive 2023 company news help provide a near term spark?
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No. 3 IKT Potential Catalyst - The Potential Market For Treating Parkinson's Disease Is Immense (Projected Global Value Of Over $12Bn Within A Decade) (1)
With a focus on neurodegenerative and infectious diseases, IKT has an opp. to secure a significant share of this market.
Market research indicates that the global neurodegenerative disorder therapeutics market could see a compound annual growth rate of 8.1%, growing from $15.86Bn in 2022 to $17.14Bn in 2023.
This growth is expected to continue at a CAGR of 8.4%, reaching $23.65Bn in 2027, driven by an aging population with a higher prevalence of neurodegenerative disorders.
By 2050, the number of people over 60 years old is estimated to increase to 2.1 billion, with those over 80 years tripling to 425 million.
The Alzheimer's Association predicts that the number of Americans with Alzheimer's disease will rise to approximately 14 million by 2050, further increasing the demand for neurodegenerative disorder therapeutics.
Therefore, a treatment from IKT could be a truly game-changing opp.
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No. 4 IKT Potential Catalyst - Company Has Strong Partnerships With Leading Research Institutions
Collaborations are central components of IKT's strategy to build and advance their pipeline of product candidates.
Through the National Institutes of Health (NIH) research grants awarded to Dr. Werner, the company has subcontracted research projects in the biochemistry of neurodegeneration to Johns Hopkins University, Arizona State University, the University of Bordeaux and the Vienna (Austria) Medical University.
In oncology, IKT has subcontracted research work to the University of California, San Francisco and the CML Consortium and consulted with clinicians at the Memorial Sloan-Kettering Cancer Center and the Medical College of Wisconsin.
The company's research endeavors have been validated by private and public granting agencies, to include the Michael J. Fox Foundation, and the National Institute of Neurological Disease and Stroke, the National Cancer Institute and the National Institute of Allergy and Infectious Disease.
IKT believes that accessing external innovation is important to their success and they plan to remain active in accessing external innovation through business development activities and awarding of private, state and federal grants through institutions such as NIH and DoD.
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IKT Recap - 4 Potential Catalysts That Could Provide This Nasdaq Biopharma With A Breakout Spark
No. 1 - FDA Ruling Paves Way For IKT To Move Forward With Key Clinical Trial
No. 2 - A Low Float Could Set The Stage For Major Volatility
No. 3 - The Potential Market For Treating Parkinson's Disease Is Immense (Projected Global Value Of Over $12Bn Within A Decade
No. 4 - Company Has Strong Partnerships With Leading Research Institutions
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Coverage is officially initiated on IKT. Do this when you can:
