After the FDA lifted its full clinical hold on IkT-148009, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is back in play. Shares closed Monday over 12% higher on heavy volume, with investors sending the stock more than 19% higher intraday. While shares closed off their highs, the momentum behind Monday's action still puts multi-month trading level highs back in the crosshairs, with its current $0.75 a share price supporting a continuation of its bullish move.
But the lift isn't the only news driving new investor interest or supporting higher share prices. Last month, IKT raised $10 million to develop treatments for Parkinson's Disease and chronic myelogenous leukemia. The deal included $4.2 million in a private investment in public equity (PIPE) deal from New York-based Armistice Capital and $5.2 million from a confidentially marketed registered direct offering. The remaining funds accrued from banking fees and commissions.
But the big news is this. While February helped set the table financially, March is proving to be a pivotal month from a clinical perspective. And if all goes according to plan, IKT could deliver a best-in-class treatment against certain neurologic disorders.
IKT Moves Back Into The Clinic
The most significant part of that proposition: the IKT mission is again in progress. In fact, this clinical-stage pharmaceutical company, which is 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, is moving forward quickly to prove its treatment candidate provides a solution to debilitating neurological conditions. And with cash in the bank, IKT may be better positioned than ever to accelerate that mission.
Moreover, the FDA is helping its cause by lifting the complete Clinical Hold on IkT-148009, IKT's c-Abl inhibitor, in Multiple System Atrophy (MSA), opening the pathway for IKT to proceed with its plans for a planned Phase 2 clinical trial in MSA. The FDA's review of IKT's response and ultimate full release of the clinical hold on IkT-148009 in MSA is a valuable event in and of itself. Indeed, investors responded in kind, buying shares of IKT at a volume pace considerably higher than its average. In fact, at roughly 1.2 million shares traded on Monday, it's the third-highest trading pace since January. And the interest is warranted.
Preclinical models have highlighted the therapeutic potential of IkT-148009 in MSA, with one of two ongoing model studies showing a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009. Now, with the clinical hold lifted and the IND back open, IKT is again on the path to completing these studies before initiating its p[lanned Phase 2a trial for this patient population. So far, the data is impressive.
To date, the IkT-148009 candidate is demonstrating effective therapeutic action. Formula-wise, the drug is a potent, selective, brain-penetrant c-Abl tyrosine kinase inhibitor that has been shown to halt disease progression, protect and restore lost neurons and clear the underlying protein pathology in animal studies of Parkinson's disease. MSA is a rare form of Parkinsonism, which occurs in a different part of the brain and advances three times faster than ordinary Parkinson's disease. IKT is on track to beat it.
Demonstrating Effectiveness In Treating Neurologic Disorders
In previously published work, Inhibikase demonstrated that MSA may also be initiated by c-Abl modification of alpha-synuclein aggregates in the brain. During ongoing animal models of MSA, IKT has observed that IkT-148009 shows a substantial neuroprotective benefit, preventing functional loss in mice following 7-week, once-daily dosing. The next steps are for the company to continue to evaluate the functional benefit of IkT-148009 for an additional 3 months to assess whether IkT-148009 leads to clearance of alpha-synuclein aggregate pathology in the treated animals. That clock is already ticking and is excellent news from a value creation perspective.
IKT's planned '202' trial design intends to 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 the 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. The clinical effect on the progression of atrophy will be monitored in the trial using MRI. The most excellent part of these studies, aside from potentially saving thousands of lives and treating a debilitating condition, is that IKT can monitor progress.
That means updates are likely, which can lead to milestones getting reached that have the potential to become catalysts.
Significant Market Opportunity In-Play
Undoubtedly, the rewards from effectively treating MSA can be substantial, resulting from Multiple System Atrophy being a rapidly progressive orphan disease affecting the central and autonomic nervous systems. While all the aspects of its destruction aren't yet known, what is known is that MSA is characterized by pathological alpha-synuclein aggregation, which may lead to cell dysfunction and degeneration of neurons. Also known, it's significantly debilitating and can be fatal, and classified as a rare disease, with approximately three individuals per 100,000 individuals per year aged 50 years or older diagnosed with the disease.
And it has no preference for gender. MSA affects men and women equally, with the onset of symptoms typically occurring in the fifth or sixth decade of life. The worst part of the disease is its rapid progression, often leading to patients becoming wheelchair reliant. The patient's condition can go downhill from there, with varying combinations of extrapyramidal dysfunction, cerebellar ataxia, dysautonomia, and parkinsonism, also likely results of the disease. Currently, no disease-modifying or symptomatic therapies exist for MSA.
And that's where the value proposition lives for IKT. They have a drug candidate demonstrating impressive disease-fighting ability. For any biotech heading into a Phase 2 trial, that opens several doors of opportunity. Of course, companies can go it alone. But being in a Phase 2 trial lends credibility to the clinical initiatives, which can open discussions with big pharma interested in getting a running start to treat an unmet medical need that brings the potential for a substantial and sustained revenue stream. That includes those already in the space, like Pfizer (NYSE: PFE), Merck (NYSE: MRK), and Eli Lilly (NYSE: LLY), who often acquire rather than develop promising therapeutic candidates.
Still, without partnerships or licensing, IKT is exploiting a sweet spot of opportunity by being further along than many in developing therapeutics for Parkinson's disease and related disorders. Moreover, they are doing things differently, advancing a multi-therapeutic pipeline intending to target the treatment of Parkinson's disease inside and outside the brain and other conditions that arise from Ableson Tyrosine Kinases.
Set Up For A Bullish Ride In 2023
In other words, IKT isn't a single shot on goal company. They have multiple indications in their crosshairs, pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that IKT believes will provide a better patient experience with fewer on-dosing side-effects.
That's not all. The Company's RAMP™ medicinal chemistry program has identified several follow-on compounds to IkT-148009 to be potentially applied to other cognitive and motor function diseases of the brain. All told, back in the clinic and flush with cash, IKT looks better positioned than ever to capitalize on its opportunities. And if all stays on plan, they can do more than capitalize; they can maximize.
Thus, with an ambitious 2023 development plan, IKT is indeed positioned to recover the value lost as they move back into the clinic. And in doing so exposes a value investment opportunity whose bullish run may be far from over.
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