Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 208

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 208
---
 DNP represents a significant area of unmet medical need. Current treatment options often provide limited relief, highlighting an opportunity for innovative therapies that can more effectively address both the physical and psychological dimensions of the condition.

DNP Diagnosis and Treatment Algorithm

The diagnosis of diabetic neuropathic pain (DNP) is multifaceted, requiring a combination of clinical assessment, neurological examination, and confirmatory diagnostic testing. Patients typically present with hallmark symptoms such as burning, tingling, or shooting pain in the extremities, often accompanied by sensory disturbances or loss of sensation.

A comprehensive patient history—focusing on diabetes duration and glycemic control—is a critical component of the diagnostic process. Neurological evaluations assess sensory function, deep tendon reflexes, and motor strength. To confirm peripheral neuropathy and exclude differential diagnoses, additional diagnostic modalities such as nerve conduction studies, electromyography (EMG), quantitative sensory testing, and imaging (e.g., MRI) may be employed. Effective diagnosis and ongoing management often require a multidisciplinary approach involving primary care providers, neurologists, endocrinologists, and pain specialists.

1Delveinsight - Diabetic Neuropathic Pain (DNP) - Market Insight, Epidemiology and Market Forecast -2034, published 2024

| Moore Financial Consulting |

| MIRA Pharmaceuticals, Inc. | April 2025   |
| Valuation                  | Page 9 of 28 |

Current Treatment Paradigm

The therapeutic management of DNP is two-pronged:

| 1. | Disease-Modifying                                                                     
 Interventions: Aimed at slowing or halting nerve fiber degeneration through optimized 
 glycemic control and management of metabolic factors.                                 |

| 2. | Symptomatic                                                                          
 Treatments: Focused on alleviating neuropathic pain and improving patient quality of 
 life, including physical and psychological functioning.                              |

Clinical guidelines generally recommend tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and γ-aminobutyric acid (GABA) analogs—namely gabapentin and pregabalin—as first-line pharmacologic agents. When first-line agents prove insufficient, second-line options such as opioids or topical therapies (e.g., capsaicin, lidocaine patches) may be considered.

Despite the availability of pharmacologic treatments, many patients report suboptimal pain relief or encounter tolerability issues, emphasizing the need for more effective and targeted therapies.

Ph