Inhibikase Halts Parkinson’s Drug Development to Focus on PAH

Inhibikase Therapeutics, Inc. (IKT), a biopharmaceutical company with a market capitalization of $189.48 million, has announced the halting of further development of its Parkinson’s disease drug, risvodetinib, following the results of a Phase 2 clinical trial. According to InvestingPro data, the company has struggled with profitability, reporting negative EBITDA of $20.04 million in the last twelve months. The trial, which enrolled 126 participants with untreated Parkinson’s disease, met its primary endpoint of safety and tolerability. However, it did not show improvement in the top hierarchical efficacy measure against placebo.

The 201 Trial, which was designed to assess the safety and efficacy of risvodetinib, a selective inhibitor of non-receptor Abelson Tyrosine Kinases, involved patients who were approximately 14 months post-diagnosis. Participants were dosed in equal proportions at 50 mg, 100 mg, 200 mg, or placebo for 12 weeks. While the drug was generally well tolerated, with adverse events comparable to placebo, it failed to demonstrate significant improvement in combined motor scores on the Movement Disorder Society Universal Parkinson’s Disease Rating Scale (MDS-UPDRS).

However, some secondary endpoints showed promise. Risvodetinib at 100 mg dosage led to a nominal improvement in Part 2 of the MDS-UPDRS, and the 50 mg dosage showed a statistically significant improvement in the Schwab & England Activities of Daily Life Scale. Additionally, the analysis suggested a potential reduction in neuronal alpha-synuclein deposition, a hallmark of Parkinson’s pathology, across all doses.

Despite these findings, the company has decided to pause the development of risvodetinib to concentrate resources on advancing its lead program, IkT-001Pro, for treating pulmonary arterial hypertension (PAH). This strategic shift comes as the stock has shown significant momentum, with InvestingPro data revealing a 78.06% price increase over the past six months, despite challenging financial metrics including a current ratio of 0.85. Inhibikase is also considering strategic options for the risvodetinib program.

The data from the 201 Trial will be presented at a future medical meeting. As the company shifts its focus, it remains committed to exploring potential strategic options for risvodetinib. The information for this article is based on a press release statement filed with the U.S. Securities and Exchange Commission. For deeper insights into IKT’s financial health and future prospects, including 7 additional key ProTips and comprehensive valuation metrics, investors can access the detailed Pro Research Report available on InvestingPro, which provides expert analysis of over 1,400 US stocks.

In other recent news, Inhibikase Therapeutics has made several significant moves. The biopharmaceutical company’s shareholders have approved an amendment to the corporate charter, increasing the number of authorized common shares from 100 million to 500 million. This move, aimed at providing flexibility for future corporate needs, was received favorably, with over 62 million votes in support.

Inhibikase Therapeutics also terminated a material definitive agreement with H.C. Wainwright & Co., LLC, which allowed the company to sell shares of its common stock through the sales agent. Despite this, the company has secured approximately $110 million in private placement financing, led by Soleus Capital and other investors.

The firm’s financial performance showed a net loss of $5.0 million for the second quarter. In response, H.C. Wainwright revised its full-year 2024 earnings per share forecast for Inhibikase to ($2.75), a decrease from the prior estimate.

In the realm of analyst assessments, Jefferies initiated coverage on Inhibikase Therapeutics with a Buy rating, citing the potential of its lead drug candidate, IkT-001Pro. However, H.C. Wainwright adjusted its outlook on the company, reducing the price target to $5.00 from the previous $15.00, while maintaining a Buy recommendation. These are the latest developments for Inhibikase Therapeutics.

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